Cholesterol Management Center, Coloserod

Cholesterol & Triglycerides Health Center

Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is optimal.

Congratulations! Your total cholesterol level is in the Desirable range, and your level of "bad" LDL cholesterol is near optimal.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is borderline high. If your LDL goes higher, your total cholesterol level could become Borderline High. Consider reducing the amount of foods you eat with saturated fats and increasing physical activity. If you get more exercise, your level of "good" HDL cholesterol may increase, which could also help to keep your levels of LDL and total cholesterol in check.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL. The HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is in the Desirable range, but your level of "bad" LDL cholesterol is Very High. This may mean that your level of high-density lipoprotein (HDL), or "good" cholesterol, is too low. It is best to have a high level of "good" HDL and a low level of "bad" LDL because the HDL helps keep your LDL level in check. Ask your doctor for your HDL level. If your HDL is low, increasing your physical activity can increase it, which may help reduce your LDL level.

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center .

Your total cholesterol level is Borderline High, but fortunately your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have other non-measured increases in LDL-like particles that can increase heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center .

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is Borderline High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. Your level of "bad" LDL cholesterol is High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is Borderline High. But your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol is High, but your level of "bad" LDL cholesterol is optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center .

Your total cholesterol is High, but your level of "bad" LDL cholesterol is near optimal. This could mean you have a high level of high-density lipoprotein, or "good" HDL cholesterol, which protects against heart disease. Or you could have elevated secondary lipids, such as non-HDL particles that increase the risk of heart disease. Your LDL level also could be optimal if you are taking a statin medication. Please check with your doctor to get your complete lipid profile and see if you may need additional treatment. In the meantime, find more information on WebMD's Cholesterol Health Center .

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is Borderline High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels!

Your total cholesterol level is High. Your level of "bad" LDL cholesterol is High, too. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe medication, such as statins. Following medication, dietary, and exercise instructions should result in improvements.

Your total cholesterol level is High, and your level of "bad" LDL cholesterol is Very High. Working to bring down your total cholesterol decreases your LDL cholesterol level. You can do this by exercising more and eating less food with saturated fats. Check food labels! If you are struggling to bring down your total cholesterol and LDL cholesterol levels, your doctor may prescribe statins or other cholesterol-lowering medications.

Thank you for signing up for the WebMD Cholesterol Newsletter!

You'll find tips and tricks as well as the latest news and research on Cholesterol.

Ultrabac® 8, Ultrabac

ULTRABAC® 8

Clostridium Chauvoei-Septicum-Haemolyticum-Novyi-Sordellii-Perfringens Types C and D Bacterin-Toxoid

For use in healthy cattle and sheep as an aid in preventing blackleg caused by Clostridium chauvoei . malignant edema caused by Cl. septicum . bacillary hemoglobinuria caused by Cl. haemolyticum, black disease caused by Cl. novyi . gas gangrene caused by CI. sordellii . and enterotoxemia and enteritis caused by Cl. perfringens Types B, C and D. Although Cl. perfringens Type B is not a significant problem in North America, immunity is provided by the beta toxoid of Type C and the epsilon toxoid of Type D. Ultrabac 8 consists of killed, standardized cultures of Cl. chauvoei . Cl. septicum . C l. haemolyticum, Cl. novyi, Cl. sordellii . and Cl. perfringens Types C and D, with an adjuvant.

Aids in the prevention of diseases caused by the clostridial agents indicated above.

Helps prevent eight clostridial diseases (including diseases caused by CI. haemolyticum and CI. perfringens Types B, C and D), which continue to be of economic importance in cattle. Clostridium bacteria are universally present and produce potent toxins that can result in rapid death of otherwise healthy animals.

Helps provide comprehensive clostridial protection in one vaccine.

Subcutaneous (SC) dose is 5 mL followed by a second dose given four to six weeks later. Annual revaccination with a single dose is recommended.

For CI. haemolyticum, repeat the dose every 6 months in animals subject to re-exposure.

ULTRABAC® 8

Clostridium Chauvoei-Septicum-Haemolyticum-Novyi-Sordellii-Perfringens Types C and D Bacterin-Toxoid

For use in healthy cattle and sheep as an aid in preventing blackleg caused by Clostridium chauvoei . malignant edema caused by Cl. septicum . bacillary hemoglobinuria caused by Cl. haemolyticum, black disease caused by Cl. novyi . gas gangrene caused by CI. sordellii . and enterotoxemia and enteritis caused by Cl. perfringens Types B, C and D. Although Cl. perfringens Type B is not a significant problem in North America, immunity is provided by the beta toxoid of Type C and the epsilon toxoid of Type D. Ultrabac 8 consists of killed, standardized cultures of Cl. chauvoei . Cl. septicum . C l. haemolyticum, Cl. novyi, Cl. sordellii . and Cl. perfringens Types C and D, with an adjuvant.

Aids in the prevention of diseases caused by the clostridial agents indicated above.

Helps prevent eight clostridial diseases (including diseases caused by CI. haemolyticum and CI. perfringens Types B, C and D), which continue to be of economic importance in cattle. Clostridium bacteria are universally present and produce potent toxins that can result in rapid death of otherwise healthy animals.

Helps provide comprehensive clostridial protection in one vaccine.

Subcutaneous (SC) dose is 5 mL followed by a second dose given four to six weeks later. Annual revaccination with a single dose is recommended.

For CI. haemolyticum, repeat the dose every 6 months in animals subject to re-exposure.

Ice Cream Flavors, Ranison

Our homemade ice cream has been a staple of the Coulee Region since 1933. It was first sold under the name Super Ice Cream and later changed to Ranison in the early 60’s. Our New York French Vanilla is our most popular flavor. The kids love the fruit flavor of our Blue Moon. Some of our other popular flavors include our Maple Nut, Butter Pecan, and Grape Nut. Stop in and try a scoop of your favorite on a cone or take it to go and share with others!

Prices are subject to market changes. Listed prices do not include tax.

Pints | $2.40 each | 2 for $4.35

Hand Packed Containers

Pints | $2.60 each

Half Gallon | $4.59 each | 2 for $8.70

2.5 Gallon Wholesale | $19.00 each

2.5 Gallon Retail | $24.00

3 Gallon Retail | $26.00 each

Scoops Plain Sugar Waffle

Cherry Chocolate Chip

Chocolate Peanut Butter

Cookies - N - Cream

New York French Vanilla

Spiced Apple Pie

Chocolate with Brownie

Mint Chocolate Chip

New York with Grape Nut Cereal

Vanilla, Cotton Candy and Blue Moon

Black Raspberry Revel

Cappuccino - N - Cookies

Sundae Flavors: strawberry, cherry, blueberry, pineapple, caramel, butterscotch.

Note: Fruit sundaes made with real fruit.

Hot Fudge Sundae $2.65

Turtle Sundae $3.03

Sodas & Floats $2.51

16 oz. | 20 oz. | 24 oz.

Shakes $2.46 | $2.84 | $3.37

Malts $2.65 | $3.08 | $3.60

Flavors: dreamsicle, blueberry, butterscotch, cappuccino, caramel, cherry, chocolate, pineapple, root beer, strawberry, vanilla.

Avalanche 16 oz. | $3.36

Avalanche Mixers: Snickers, Heath, M&M, Oreo, Reese’s Peanut Butter Cups.

© Copyright 2015 Ranison Ice Cream & Candy | All Rights Reserved

Sequinan Indication, Action Of Sequinan, Interactions, Sequinan

Sequinan [in more detail]

Sequinan Indication:

For the treatment of schizophrenia in adults and in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17.

Sequinan Mechanism Of Action:

Blockade of dopaminergic D2 receptors in the limbic system alleviates positive symptoms of schizophrenia such as hallucinations, delusions, and erratic behavior and speech. Blockade of serotonergic 5-HT 2 receptors in the mesocortical tract, causes an excess of dopamine and an increase in dopamine transmission, resulting in an increase in dopamine transmission and an elimination of core negative symptoms. Dopamine receptors in the nigrostriatal pathway are not affected by risperidone and extrapyramidal effects are avoided. Like other 5-HT 2 antagonists, risperidone also binds at alpha(1)-adrenergic receptors and, to a lesser extent, at histamine H1 and alpha(2)-adrenergic receptors.

Sequinan Drug Interactions:

Food Interactions:

Erdon Gel Ohne Rezept, Erdon Gel

Diclofenac ohne rezept

Diclofenac is used primarily for the treatment of inflammation and pain caused by conditions such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is also effective in treating soft tissue inflammations due to tendinitis and bursitis, and treating dysmenorrhea (menstrual cramps). Diclofenac is an NSAID. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Use Diclofenac as directed by your doctor!

Take Diclofenac by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.

Take Diclofenac with a full glass of water (8 oz/240 mL) as directed by your doctor.

If you miss a dose of Diclofenac, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Diclofenac.

Store Diclofenac at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diclofenac out of the reach of children and away from pets.

Do NOT use Diclofenac if:

you are allergic to any ingredient in Diclofenac or to bovine (cow) protein

you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)

you have recently had or will be having bypass heart surgery

you have severe kidney problems

you are in the last 3 months of pregnancy.

Contact your doctor or health care provider right away if this applies to you.

Some medical conditions may interact with Diclofenac. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of kidney or liver problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)

if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation

if you have high blood pressure, blood disorders (eg, porphyria), bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases

if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you smoke, drink alcohol, or have a history of alcohol abuse

if you are taking an antibiotic or an anti-seizure medicine. The risk of liver problems may be increased with some of these medicines.

Some medicines may interact with Diclofenac. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin), aspirin, clopidogrel, corticosteroids (eg, prednisone), heparin and other blood thinners (eg, dalteparin), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased

Acetaminophen because the risk of liver problems may be increased

Probenecid because it may increase the risk of Diclofenac's side effects

Cyclosporine, lithium, metformin, methotrexate, oral NSAIDs (eg, ibuprofen), or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Diclofenac

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Diclofenac.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diclofenac may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

Diclofenac may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Diclofenac with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.

Serious stomach ulcers or bleeding can occur with the use of Diclofenac. Taking it in high doses, for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Diclofenac with food will NOT reduce the risk of these effects. If you have severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling, contact your doctor or emergency room right away.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

Diclofenac is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not take aspirin while you are using Diclofenac unless your doctor tells you to.

Check with your doctor or pharmacist before you take acetaminophen while you are taking Diclofenac. The risk of liver problems may be increased.

Do not switch between different forms of Diclofenac (eg, enteric-coated tablets, immediate-release tablets, capsules) unless your doctor tells you to. They may not provide the same amount of medicine to your body.

Lab tests, including kidney function, liver function, blood electrolyte levels, complete blood cell counts, and blood pressure, may be performed while you use Diclofenac. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Diclofenac with caution in the elderly; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.

Diclofenac should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.

Pregnancy and breast-feeding: Diclofenac may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Diclofenac while you are pregnant. It is not known if Diclofenac is found in breast milk. Do not breastfeed while taking Diclofenac.

Rockville Elder Law, Columbia Elder Law, Maryland Elder Law - Felinton Elder Law - Estate Planning C

Felinton Elder Law & Estate Planning Centers provides legal guidance to preserve a family's assets.

ARE YOU LOOKING FOR A ROCKVILLE. COLUMBIA. FREDERICK, MARYLAND, WASHINGTON D. C. OR FLORIDA ELDER LAW FIRM? Look no further! With over 33 years of experience, our elder law services are customized to you and your family.

WE COVER ALL ASPECTS OF ELDER LAW for aging, illness and incapacity including Medicaid Planning, Veterans Benefits, Nursing Home Planning, Asset Protection and Advocating for our clients.

WITH PROPER ESTATE PLANNING one can ensure their health care needs will be met, and their assets will be distributed according to their wishes. There are many options available to people in the estate planning process, including wills, living trusts, testamentary trusts, durable powers of attorney, and living wills. However, not all options are right for everyone.

The estate planning services we provide include Health Care Proxy, Powers of Attorney, Probate. Last Will and Testament, Revocable Living Trusts, Asset Protection Trusts and Pet Trusts.

MINDY ALSO HOSTS A WEEKLY TV SHOW . "Senior Solutions" on the Montgomery Municipal Cable Channel 16 where she discusses topics impacting seniors and their families.

MINDY FELINTON IS ACCREDITED BY THE DEPARTMENT OF VETERANS AFFAIRS (VA) for the preparation, presentation and prosecution of claims for benefits for wartime veterans age 65 and older. We provide legal services for Pensions, Compensation, Medical Care, Housing Assistance, Cemetery Assistance and Burial Assistance.

WE ARE A FULL SERVICE LAW FIRM with offices in Maryland, Washington D. C. and Florida, covering the legal issues affecting the lives of the elderly, their loved ones and all who are interested in preparing their legal and financial affairs for the future to protect their loved ones. Our focus is to provide you with an individualized plan for the future and to protect and preserve the lifetime of savings you and your loved ones have worked so hard to accumulate.

MS. FELINTON IS A MEMBER of the Maryland, Pennsylvania, District of Columbia and Florida Bar Associations.

Interview with Mindy

Selgin (Selegiline) - United Pharmacies, Selgin

Selgin

Description

Selgin (Selegiline) is used to help control the symptoms of Parkinson`s disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) in people who are taking levodopa and carbidopa combination. This medicine may help people with Parkinson`s disease by decreasing the dose of levodopa/carbidopa needed to control symptoms, stopping the effects of levodopa/carbidopa from wearing off between doses, and increasing the length of time that levodopa/carbidopa will continue to control symptoms.

This medicine is in a group of medications called monoamine oxidase type B (MAO-B) inhibitors. It works by increasing the amount of dopamine (a natural substance that is needed to control movement) in the brain.

Dosage and Administration

Selgin (Selegiline) tablets should be taken orally. Patients may be directed to take this medication twice daily. In order to avoid difficulty sleeping, patients are often directed to take this medication at breakfast and lunchtime. The standard maximum dosage is 5mg twice per day.

Patients should always consult their physician before taking this drug, and never exceed the dosage prescribed to them. If your physician has directed you to take this drug together with another drug to treat Parkinson`s disease, such as levodopa, you may be instructed to decrease your dosage of levodopa after you have been taking selegiline for 2 to 3 days.

Patients should be aware that it may take a few weeks for the full effects and benefits of this drug to be noticed. You should never discontinue taking this drug unless you have been directed to do so by your physician.

Selgin (Selegiline) may cause stomach upset, loss of appetite, nausea, heartburn or dry mouth. These effects should subside as your body adjusts to the medication. If they continue or become bothersome, inform your physician. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use saliva substitute.

Infrequently, this medication may increase the skin`s sensitivity to sunlight. If this happens to you, avoid prolonged sun exposure, wear protective clothing and use a sunscreen. Avoid sunlamps. This medication can cause dizziness and lightheadedness especially during the first few days of therapy. Avoid tasks requiring alertness if you experience these effects.

Notify your physician promptly if you develop any of the following side effects: severe headache, chest pain, irregular heartbeat, tremors, clumsiness, confusion, involuntary movements (especially of the hands or face), nightmares, hallucinations, difficulty breathing, difficulty urinating. If you notice other effects not listed above, contact your physician or pharmacist.

Selgin (Selegiline) should not be used with the certain other medicines, as a serious reaction may occur. Inform your physician of all medicine you are taking before the commencement of treatment.

Consult your physician about the need to watch your intake of foods containing tyramine. It is possible consuming tyramine - containing foods while using this medication could cause headache and/or increased blood pressure and could lead to a medical emergency. Tyramine food precautions should be observed for at least 2 weeks after you stop using this medication.

Ibupal, Ibupal

Arthritis - Ibupal (Brand name: motrin)

Motrin is used for treating rheumatoid arthritis, osteoarthritis, menstrual cramps, or mild to moderate pain. Motrin is an NSAID. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Use Motrin as directed by your doctor.

Take Motrin by mouth with or without food. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.

Take Motrin with a full glass of water (8 oz/240 mL) as directed by your doctor.

If you miss a dose of Motrin and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about the proper use of Motrin .

Store Motrin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Motrin out of the reach of children and away from pets.

Active Ingredient: Ibuprofen.

Do NOT use Motrin if:

you are allergic to any ingredient in Motrin

you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)

you have recently had or will be having bypass heart surgery

you are in the last 3 months of pregnancy.

Contact your doctor or health care provider right away if any of these apply to you.

Some medical conditions may interact with Motrin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal product, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)

if you have a history of swelling or fluid buildup, lupus, asthma, or growths in the nose (nasal polyps), or mouth inflammation

if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases

if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you drink alcohol, or you have a history of alcohol abuse.

Some medicines may interact with Motrin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased

Probenecid because it may increase the risk of Motrin 's side effects

Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Motrin

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Motrin.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Motrin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

Motrin may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Motrin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.

Serious stomach ulcers or bleeding can occur with the use of Motrin. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Motrin with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Do not take more than the recommended dose or use for longer than prescribed without checking with your doctor.

Motrin has ibuprofen in it. Before you start any new medicine, check the label to see if it has ibuprofen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not take aspirin while you are using Motrin unless your doctor tells you to.

Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be done to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Motrin with caution in the elderly; they may be more sensitive to its effects, including stomach bleeding and kidney problems.

Motrin should be used with extreme caution in children; safety and effectiveness in children have not been confirmed.

Pregnancy and breast-feeding: Motrin may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Motrin while you are pregnant. It is not known if Motrin is found in breast milk. Do not breastfeed while taking Motrin .

All medicines can cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach pain or upset.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

Tag Archives: Ibupal

Ibuprofen (Brufen)

Ibuprofen (Brufen) is used for relief of symptoms of arthritis, primary dysmenorrhea, fever, and as an analgesic, especially where there is an inflammatory component. Ibuprofen functions in the body by blocking the action of a substance in the body called cyclo-oxygenase that is involve in the production of various chemicals in the body such as prostaglandins that causes inflammation, pain, and swelling. In other words, Ibuprofen is used to relieve pain and inflammation. Ibuprofen reduce inflammation caused by the body’s own immune system, is an effective painkiller, relieves pain such as muscular aches and pains, headache, backache, period pains, rheumatic pains, neuralgia, and dental pains. Ibuprofen also reduces the symptoms of colds and flu.

The recommended dose varies with body mass and indication. Generally, the oral dose is 200–400 mg (5–10 mg/kg in children) every 4–6 hours, adding up to a usual daily dose of 800–1,200 mg. 1,200 mg is considered the maximum daily dose for over-the-counter use, though under medical direction, the maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Take this medication by mouth with a full glass (8 ounces or 240 milliliters) of water unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this drug. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Do not take the over-the-counter product for more than 10 days unless otherwise directed.

Other Names : Advil, Apsifen, Arthrofen, Brufen, Cuprofen, Ebufac, Fenbid, Galprofen, Genpril, Haltran, Ibrufhalal, Ibu, Ibufac, Ibufem, Ibugel, Ibular, Ibuleve, Ibumousse, Ibuspray, Inoven, Isisfen, Junifen, Librofem, Lidifen, Manorfen, Menadol, Migrafen, Motrin, Novaprin, Orbifen, PhorPain, Relcofen, SeclodinU, niprofen, ACT-3, Actiprofen, Rafen, Tri-Profen, Novo-Profen, Cipgesic, Emflam, Ibugesic, Ibupal, Ibucare, Panafen, Profinal, Artril, Bebol, Ibu-600, Biophen, Anadin Ultra, Biatain-Ibu, Feverfen, Hedex Ibuprofen, Ibuleve, Pedea, Phor Pain, Radian-B Ibuprofen, Ibu-Tab, Ibu-4, -6, -8, Ibu, Cramp & Body Aches, NeoProfen, Saleto-200, Femicaps, Femmex Plus, Pedibu, Lumbax

Recent Posts

Pages

Blood Pressure - Cardilock (Brand Name Tenormin) (Atenolol), Cardilock

Blood Pressure - Cardilock (Brand name: tenormin)

Common use Tenormin is a beta-adrenergic blocking agent. Its role is to block the effects of adrenergic drugs, such as adrenaline or epinephrine, on nerves of the sympathetic nervous system. Tenormin reduces the heart rate and is used for treatment of abnormally rapid heart rhythms, arterial hypertension, angina, acute myocardial infraction, tachycardia (different types), ventricular fibrillation and others.

Dosage and direction Take Tenormin before meals or at bedtime. Your dose depends on your condition and should be administered by your doctor. Take the medication exactly as prescribed. Do not change the dose and do not stop suddenly treatment even if you feel better as hypertension often has no symptoms. Avoid drinking alcohol. Let your surgeon know if you are taking Tenormin if you plan to be operated.

Precautions Do not take Tenormin if it was not Tenormin should be taken with a glass of water once a day at the same time. Do not stop taking the medication suddenly as it may worsen your condition. Continue taking the medication even if you feel fine as hypertension and diseases of a heart maybe a life long illness. Inform your surgeon if you take Tenormin, if you need to be operated.

Hypersensitivity, sick sinus syndrome, sinus bradycardia (rate slower than 50 per minute), atrioventricular block (degree II and III), arterial hypotension, acute or chronic heart failure, peripheral blood flow disorders, breastfeeding. Cautiousness should be exercised in patients with diabetes, hypopotassemia, pulmonary emphysema, asthma, liver and kidney diseases pregnancy and with other conditions.

Possible side effect Side effects are rare and transient if occur. They may include weakness, fatigue, dizziness, headache, depression, dreaming, insomnia, memory loss, abdominal cramps, diarrhea, constipation, nausea, fever, impotence, lightheadedness, slow heart rate, low blood pressure, numbness, tingling, cold extremities, and sore throat and also allergy.

Drug interaction Tenormin can aggravate conditions of patients with asthma, chronic bronchitis, or emphysema. In patients with slow heart rates and heart blocks, Tenormin can slow up heart rates considerably. Tenormin reduces the force of heart muscle contraction and worsens conditions of patients with heart failure. Non-steroidal anti-inflammatory drugs, estrogens, sympathomimetics, xanthines weaken hypotensive effect of Tenormin.

Missed dose Never take a double dose of this medication. If it is almost time of the next dose just skip the missed portion and continue taking the medicine according to the schedule.

Overdose Symptoms of an overdose are uneven heartbeats, shortness of breath, dizziness, weakness, fainting, bluish-colored fingernails, convulsions. If you experience this, call your doctor immediately.

Storage Tablets should be stored at room temperature between 25-25 C (68-70 F) away from light and moisture.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Alfarnate In Axarquia, Costa Del Sol, Andalucia, Spain, Farnat

Size of Municipality: 34 km2 Altitude: 925 m Distance to Malaga: 49 km Distance to coast: 45 km Average sunshine per day: 7.47 hrs Population: 1,600 Inhabitants: Alfarnate?os

Alfarnate is the most northerly village of Axarquia . situated 49 kilometres from Malaga and 45 kilometres from the coast at Torre del Mar on the scenic Route of Olive Oil and Mountains . It lies on a fertile plain sheltered and hidden by the surrounding Sierra Alhama and Sierra El Jobo mountains at an altitude of 925 metres, and has a population of 1,600. Against the mountain backdrop, the flat cultivated land forms a contrasting scene.

The economy is based on agriculture, the main products of which are olives, almonds, chickpeas, cherries and cereals. The cherries grown in the area are large and tasty and celebrated each year at an annual festival. For the occasion, a large marque is erected in the park where the different producers offer their wares, accompanied by music and folklore to entertain the thousands of visitors. Details of this and Alfarnate?s other annual festivals can be found at the fiestas link at the bottom of this page.

Typical of the area, the village has prehistoric origins with later Moorish occupation and architecture. Unlike most other villages in Axarquia, Alfarnate is flat with wide streets. The river Palancar winds through the village dividing it in two joined by three picturesque bridges. The name, Alfarnate, is derived from the 10th century Arab Al-farnat which means flour-mill. The 16th century church of Santa Ana has a Mudejar minaret.

The town is overlooked by the small Cerro del Santo Cristo mountain, which has a sanctuary on top of the same name, where outdoor mass is sometimes held. The buildings in the town are mostly two storey and typically whitewashed. The most historic street, Calle Secretar?a, houses numerous 16th century buildings and the Plaza del Ayuntamiento where bullfighting used to take place during the September festival.

In the 19th century the town was an important bandit centre, due to its geographical location on the road between Malaga and Granada. Just outside of the village is an inn built in 1690, the Venta de Alfarnate, where bandits took refuge from their pursuers. It was a haunt for famous bandits El Tempranillo and Luis Candelas and is now a museum and restaurant where delicious regional dishes are prepared and served.

Official Fiestas: April 25th September 12th Popular Fiestas: Early February - Fiesta of the Virgen de la Candelaria Late April - Festival of San Marcos Early May - May Day Mid June - Festival of San Antonio End June - Day of the Cherry Mid September - Feria of Alfarnate

Useful Numbers: Emergency Doctor: 061 Emergency Police: 091 Town Council: 952 759 028

Your #1 Choice For Boats For Sale In Maine, Finprostat

Your #1 Choice for Boats for Sale in Maine

Hamlin’s Marine wants you to enjoy every moment on the water.

For over twenty years Hamlin’s Marine has delivered on a simple promise… ”If you purchase a boat from Hamlin’s Marine, we’ll always be there when you need us.” Hamlin’s Marine offers convenience and assurance with our locations in Waterville and Hampden, staff of twenty-five dedicated employees, and a fleet of service trucks.

At Hamlin’s we only sell boats that we can stand behind. Our manufacturers include Bennington Pontoons. Stingray. Mastercraft. Cutwater. Northcoast. Puffin. Alumacraft. Achilles. Scout Boats. and Yamaha Outboards. These manufacturers lead the industry in quality construction, and make it easier to serve you when it matters most.

So come on in and choose from our selection of new and used Pontoon Boats, Tow Boats or any other fishing boats or family fun boats. With two easy locations in Waterville, Maine (Boat Sales and Service) or Hampden, Maine (Boat Sales, Service, and Marina) it couldn't get any more convenient. Choose Hamlin’s Marine as your boat dealer, service center, marina, and indoor storage facility, and we promise you’ll make wonderful memories on the water in Maine.

At Hamlin's Marine we stand behind all of our boats for sale in Maine .

Why Buy From Hamlin's Marine:

31 Years in Business

#1 Yamaha Outboard Dealer in New England for 5 Years in a Row

Alumacraft is America's #1 selling Deep V Aluminum Fishing Boat

Multiple Locations to serve you

Fleet of ten service and delivery trucks

Skin Allergy Causes And Treatments, Allecet

Skin Allergy Causes and Treatments

Updated September 13, 2016

Skin allergies can be very annoying and bothersome. While all the conditions leading to skin allergy cause red, itchy skin, there are a number of differences in the causes as well as treatments and side effects.

What Are Skin Allergies?

Skin allergies are one of the many different skin conditions that may impact you. At a basic level, skin allergies are an allergic reaction to a normally harmless substance.

Your immune system normally fights a foreign substance and removes it from your body. When the immune system sees a substance as foreign and reacts, you can develop an allergic skin rash. When your body interacts with one of the triggers mentioned below, you develop a reaction to the trigger that most others do not and you end up with symptoms.

Common Signs & Symptoms of Skin Allergy

When you experience a skin allergy, you might experience a combination of the following:

Atopic Dermatitis Versus Contact Dermatitis: How to Tell the Difference

Love Essential Oils? Make Sure You're Not Allergic

While you would expect to develop similar symptoms if you come into contact with the trigger again, you may develop any of these symptoms with any exposure.

Common Causes of Skin Allergies

A number of different triggers can lead to skin allergy, including:

What Are Common Allergic Skin Conditions?

A number of different allergic skin conditions may impact you, including:

Eczema. Also referred to as atopic dermatitis, this skin condition most frequently starts in the first couple years of life, but it can first appear in an adolescent or adult.

In the first several months of life the rash may occur almost anywhere, but most commonly occurs on the extensor surfaces (e. g. knee and elbow), chest, cheeks, and scalp—areas where the child is able to scratch and further irritate the skin. The rash is often red, itchy, scaly, and crusty. It may also ooze and generally spares the diaper area.

In older children, adolescents, and adults, the rash most commonly occurs in the flexural areas (behind the knees and opposite area of the elbow). Scratching and rubbing of the skin may result in an exaggeration of normal skin markings and abnormal pigmentation called lichenification. This may result in a leathery bark-like appearance that is often referred to as a “atopic dirty neck.” The rash can also occur anywhere on the eyebrow, hands, neck, and face.

Contact Dermatitis . This reaction is most commonly due to an irritant, but an allergic reaction is also possible. Inflammation of the skin results after contact between an allergic trigger substance and your skin.

Most Common Location for Eczema

Atopic Dermatitis Treatment for About $10 A Month

While the rash can look very similar to eczema, the rash normally only occurs where the skin has had contact with the offending agent. The face, eyelids, neck, hands, and feet are commonly affected areas. While poison ivy, poison oak, and poison sumac are the most common causes of allergic contact dermatitis, nickel allergy (commonly seen in jewelry), cosmetics, antibiotic creams, rubber, and the chemicals on shoes also commonly lead to this skin allergy.

Hives . Urticaria, the medical term for hives, is an itchy rash that can indicate a significant underlying medical condition. You may notice raised pink/red bumps that appear to be of various sizes and shapes. The raised pink/red spots have pale centers on the skin. The hive spots may quickly change in location, size, and shape. While you may experience itching, it is usually not significant enough to lead to breaking skin.

Hives are generally treated with an over-the-counter antihistamine. It won’t cure the hives, but it will relieve itching and potentially decrease the number of skin lesions.

Hives are not contagious.

Foods (e. g. peanuts, eggs, nuts, and shellfish), latex, medications (especially antibiotics such as penicillin and sulfa, aspirin, and ibuprofen), insect stings, and physical stimuli such as pressure, cold, heat, exercise, or sun exposure can all cause hives.

Angioedema. Most commonly associated with hives, angioedema is a swelling that might involve lips, the eyes, and the hands and feet. Patients describe an abnormal stinging or tingling sensation, but it is generally not itchy or red.

When to See Your Doctor

Angioedema and hives are significant allergic skin conditions that can be part of a medical emergency. If you have angioedema of the face and neck there is a risk that you could develop significant breathing problems. These problems can be treated with systemic steroids to help decrease swelling and other symptoms. You should seek care immediately for any breathing problems or a significant worsening of symptoms.

The most serious reaction to a trigger, anaphylaxis. is a medical emergency that must be treated with an injection of epinephrine.

Is There Such a Thing as a Sun Allergy?

Eritrofarm, Eritrofarm

Antibiotics - Eritrofarm (Brand name: erythromycin)

Product Description Common use Erythromycin is in a group of drugs called macrolide antibiotics. Erythromycin is used to treat many different types of infections caused by bacteria. It is also used to prevent bacterial endocarditis and attacks of rheumatic fever.

Dosage and direction Take Eritrofarm exactly as it was prescribed for you. Take each dose with a full glass (8 ounces) of water. Erythromycin can be taken on an empty stomach or with food or milk. Do not crush, chew, break, or open an enteric-coated or delayed-release pill. Swallow the pill whole.

Precautions Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Contraindications Do not use this medication if you are allergic to erythromycin, or if you are also taking cisapride (Propulsid) or pimozide (Orap). If you have liver disease or myasthenia gravis, you may need a dose adjustment or special tests to safely take erythromycin. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Erythromycin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Possible side effects Get emergency medical help if you have any of these signs of an allergic reaction to erythromycin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: chest pain, uneven heartbeats, feeling light-headed or fainting; nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or diarrhea that is watery or bloody. Less serious Eritrofarm side effects may include: mild nausea, vomiting, diarrhea, or stomach pain; dizziness, headache, feeling tired; vaginal itching or discharge; or mild itching or skin rash.

Drug interaction Many drugs can interact with erythromycin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Missed dose Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Overdose Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, diarrhea, stomach pain, or hearing loss.

Storage Store this medication at room temperature away from moisture and heat.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. The specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Product Description Common use Erythromycin is in a group of drugs called macrolide antibiotics. Erythromycin is used to treat many different types of infections caused by bacteria. It is also used to prevent bacterial endocarditis and attacks of rheumatic fever.

Dosage and direction Take erythromycin exactly as it was prescribed for you. Take each dose with a full glass (8 ounces) of water. Erythromycin can be taken on an empty stomach or with food or milk. Do not crush, chew, break, or open an enteric-coated or delayed-release pill. Swallow the pill whole.

Precautions Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Contraindications Do not use this medication if you are allergic to erythromycin, or if you are also taking cisapride (Propulsid) or pimozide (Orap). If you have liver disease or myasthenia gravis, you may need a dose adjustment or special tests to safely take erythromycin. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Erythromycin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Possible side effects Get emergency medical help if you have any of these signs of an allergic reaction to erythromycin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: chest pain, uneven heartbeats, feeling light-headed or fainting; nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or diarrhea that is watery or bloody. Less serious erythromycin side effects may include: mild nausea, vomiting, diarrhea, or stomach pain; dizziness, headache, feeling tired; vaginal itching or discharge; or mild itching or skin rash.

Drug interaction Many drugs can interact with erythromycin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Missed dose Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Overdose Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, diarrhea, stomach pain, or hearing loss.

Storage Store this medication at room temperature away from moisture and heat.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. The specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Terfex, Terfex

To give you the best prices we have decided to give BIG discounts to people buying in bulk. If you are buying more than 10 of a single item we can give you discounts. This means you will be getting the goods at wholesale prices and can make ALOT of money reselling it to friends, family or even in your shop! Buying in bulk at these cheap prices also means you could resell on ebay and make yourself some extra money on the side.

If you are wanting to order more than 10 of a single item, please fill out the form below and one of our staff will get back to you with a quote.

Name Of Product And Amount (and your country):

Live Help & Support!

Want help? Call us at or click below for live chat.

Tuesday 20 September, 2016

Copyright ? 2003-2009 Terfex. com

Buy Apo-Doxan (Cardura) Online Without A Prescription, Apo-Doxan

Buy Apo-doxan (Cardura) Without Prescription

Apo-doxan (Cardura) Description

Apo-doxan is a perfect remedy in struggle against hypertension, symptoms of benign prostatic hyperplasia or enlarged prostate.

Apo-doxan acts by relaxing the blood vessels and muscles of bladder and prostate.

Apo-doxan is also known as Doxazosin, Apo-doxann, Cascor, Doxadura, Doxacard.

Generic name of Apo-doxan is Doxazosin.

Brand names of Apo-doxan are Apo-doxan, XL Apo-doxan.

Apo-doxan (Cardura) Dosage

Apo-doxan is available in:

1mg Low Dosage

2mg Standard Dosage

4mg Increased Dosage

Take Apo-doxan tablets orally once a day with or without food in the morning or in the evening, extended-release tablets take once a day with a breakfast.

Do not crush or chew it.

If you want to achieve most effective results do not stop taking Apo-doxan suddenly.

Apo-doxan (Cardura) Missing of dose

Do not take double dose. If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule.

Apo-doxan (Cardura) Overdose

If you overdose Apo-doxan and you don't feel good you should visit your doctor or health care provider immediately.

Apo-doxan (Cardura) Storage

Store at room temperature below 30 degrees C (86 degrees F) away from moisture and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children.

Apo-doxan (Cardura) Side effects

Apo-doxan has its side effects. The most common are:

migraine

fatigue

gain of weight

muscle pain

arthralgia

weakness

problems with vision

runny nose

problems with sexual life

lightheadedness

diarrhea

stomach pain

Less common but more serious side effects during taking Apo-doxan:

allergy reactions (urticaria, breathing difficulties, rash, and eruption)

irregular heartbeat

chest pain

fainting

painful erection

pounding heartbeat

Side effects manifestations are not only depend on medicine you are taking but also depend on your health state and on the other factors.

Apo-doxan (Cardura) Contra-indications

Do not take Apo-doxan if you are allergic to Apo-doxan components.

Do not take Apo-doxan if you're pregnant or you plan to have a baby, or you are a nursing mother.

Be careful using Apo-doxan if you take HIV/AIDS medicines (nelfinavir (such as Viracept), atazanavir (such as Reyataz), indinavir (such as Crixivan), saquinavir (such as Invirase, Fortovase), ritonavir (such as Kaletra, Norvir)); clarithromycin (such as Prevpac, Biaxin); ipratropium (such as Atrovent); nefazodone; telithromycin (such as Ketek); voriconazole (such as Vfend); antihistamines; itraconazole (such as Sporanox); ketoconazole (such as Nizoral); ED medicines (vardenafil (such as Levitra); sildenafil (such as Viagra), tadalafil (such as Cialis); high blood pressure medicines; ulcers, irritable bowel disease medicines, urinary medicines, Parkinson's disease, motion sickness medicines.

It can be dangerous to use Apo-doxan if you suffer from or have a history of prostate cancer, chest pain (angina), intestines narrowing or blockage, liver disease, short bowel syndrome, hypertension.

Do not stop taking Apo-doxan suddenly.

Apo-doxan (Cardura) Frequently asked questions

Q: What is Apo-doxan?

A: Apo-doxan is a high-quality medication which is taken in treatment of symptoms of benign prostatic hyperplasia or enlarged prostate, hypertension. Apo-doxan acts by relaxing the blood vessels and muscles of bladder and prostate.

Q: How should I take Apo-doxan?

A: Apo-doxan is available in tablets (1 mg, 2 mg, 4 mg). Take Apo-doxan tablets orally once a day with or without food in the morning or in the evening, extended-release tablets take once a day with a breakfast. Do not crush or chew it. If you want to achieve most effective results do not stop taking Apo-doxan suddenly.

Q: What should I do in case of overdose?

A: Do not take Apo-doxan tablets in large quantities. In case of Apo-doxan overdosage, you need to visit doctor or health care provider immediately.

Q: Is it possible to drink alcohol?

A: No, it is forbidden to drink alcohol.

Buy Apo-doxan (Cardura) online, buy Apo-doxan (Cardura) online without a prescription, buy Apo-doxan (Cardura) without prescription, buy Apo-doxan (Cardura) cheap, buy Apo-doxan (Cardura) without a prescription, buy Apo-doxan (Cardura) from Canada, buy Apo-doxan (Cardura) Canada, order Apo-doxan (Cardura) online, order Apo-doxan (Cardura) online no prescription, order Apo-doxan (Cardura) without prescription, Apo-doxan (Cardura) oral pill

Gold Cross Paracetamol, Duokapton

Gold Cross Paracetamol

Chemical Name

Chemical Formula

Other Brand Names

2-A

A-Mycin

A-Per

Abdine

Abrol

Abrolet

Acamol

Acamoli

Ace

Acecat

Acenol

Acephen

Acertol

Acet

Aceta

Acetafen

Acetagen

Acetalgin

Acetalis

Acetamin

Acetaminofen

Acetaminofen

Acetaminofen MK

Acetaminophen

Acetaminophen and Codeine Phosphate

Acetaminophen and Pentazocine hydrochloride

Acetamol

Acetazone Forte

Acetolit

Aceval

Actadol

Actol

Adalgur

Adco-Paracetamol

Adinol

Adol

Adol PM

Adol Sinus

Adolef

Adorem

Aeknil

Afebryl

Agurin

Aldolor

Algiafin

Algicalm

Alginox

Algisedal

Algocod

Algopirina

Algostase

Algostase mono

Algotropyl

Alikal

Alivax

Alphamol

Alvedon

Ametrex

Amifen

Amipar

Amol

Anacin

Anadin Paracetamol

Analgan

Analgiplus

Analper

Ananty

Andox

Anexsia

Anhiba

Anti-Gripe Asclepius

Antidol

Antigriphine

Antigrippine

Anyrume

APA

APAP

Apap C Plus

Apap Extra

Apap Noc

APC-Acetaminophen

Aphlogis

Apiret

Apiretal

Apiretal Codeina

Apo-Acetaminophen

Apo-Oxycodone/Acet

Aporex

Apotel

Apracur Granulado

Apyrene

Arfen

Arthrifen Plus

Asta

Atamel

Atasol

Atenemen

Atmiphen

ATP

Atralidon

Azur

Azur compositum

Baby Rinolo

Babyfever

Becetamol

Ben-u-ron

Benuron

Benylin Cold and Sinus

Beres Febrilin

Besemax

Besenol

Biogesic

Biogrip-T

Bodrex

Bodrex forte

Brexin

Buscopan compositum

Buscopan plus

Butapap

Calapol

Calonal

Calpol

Calpol 6 plus

Calpol Paediatric

Calsil

Capital and Codeine Phosphate

Captin

Catajap

Causalon

Cebion Febbre

Cefecon D

Cefekons

Cemol

Cetadol

Cetafrin

Cetal

Cetalgin

Cetamol

Chefarine

Children's Bufferin

Children's Panadol

Children's Tylenol

Citrosan

Claradol

Co-Becetamol

Co-Becetamol fur Kleinkinder

Co-Dafalgan

Co-Efferalgan

Cocarl

Cod Efferalgan

Codalgin

Codipar

Codipar Plus

Coditam

Coldrex Sinus

Contac

Contac Cold & Sore Throat, Non Drowsy

Contra-Schmerz P

Contraneural

Contratemp

Copyrkal

Cotibin Compuesto

Couldrex

Coxumadol

Crocin

Croix Blanche

Cupanol

Curadies Paracetamol

Curpol

Curpol Junior

Cytramon-P

Dafalgan

Dafalgan Bebe

Dafalgan C

Dafalgan Codeine

Dafalgan Enfant

Dafalgan Odis

Dafalgan Pediatrie

Dafalgan plus C

Daga

Daimeton

Daleron

Daleron C

Daleron C junior

Dalminette

Daro Hoofdpijnpoeder

Daro Paracetamol

Darvocet

Day & Night

Daygrip

Decolgen ACE

Demogripal C

Dentonibsa

Dentopain [+ Ibuprofen>

Depalgos

Depyrin

Dexamol

Dexamol Kid

Dhamol

Dialgine

Dimetapp Daytime Cold Extra Strength

Dirox

Disprol

Distalgesic

Doc Para

Docpara

Docparacod

Docpelin Paracetamol

Dolal

Dolel

Dolevar

Dolex

Dolgesic

Dolgesic Codeina

Doliprane

Dolitabs

Dolko

Dolocare

DoloCitran C

Dolofebril

Dolol Instant

Dolomedil

Dolomol

Dolomolargesico

Dolostop

Dolotec

Dolprone

Doluvital

Dolviran

Dopagan

Dopalgan

Dopalogan

Dopamol

Dorbigot

Doregrippin

Dorocol

Doxyfene

Dozol

Dristan N. D.

Dumin

Duokapton

Duorol

Dymadon

Efagesic

Eferalgan

Efetamol

Effect

Efferalgan

Efferalgan Vitamina C

Efferalganodis

Ekosetol

Emidol

Empacod

Empaped

Emtacetamol

Enddol

Endocet

Enelfa

Enelfa Dr. Henk

Erphamol

Espaven

Ethics Paracetamol

Expandox

FAP

Farmadol

Fast

Fea

Febrax

Febrectal

Febrectal Infantil

Febrex

Febricet

Febridol

Febrilix

Felibrix

Femerital

Fevac

Fevadol

Feverall

Fevrin

Fibrex

Fibrexin

Fibrimol

Filanc

Finimal

Finimal C

Fitamol

Flaviston E

Flectadol

Flogodisten

Fludeten

Fludrex

Fluental

Flutabs

Fortamol

Frenagial

Gabbrocet

Gamatherm

Gelocatil

Gelocatil Codeina

Gelonida

Geluprane

Genapap

Genebs

Geniol-P

Genspir

Geralgine-P

Getol

Gitas Plus

Go-Gesic

Gripakin

Gripostad

Grippex

Grippostad

Grippostad Heissgetrank

Hapacol

Head-O

Hedex

Hepa

Hexplider-C

Hot Coldrex

Hydrocodone bitartrate and Acetaminophen

Ibumol

Ibupain

Infadrops

Infants' Feverall

Infants' Tylenol

Infapain

Influbene C

Influbene N

Intaflam

Iremax

Isalgen Compuesto

Itamol

Itedal

Ixprim

Jagcin

Junior Parapaed

Kafa

Kafa Flashtabs

Kafa plus Koffein

Kapake

Kelvin

Kenox

Kinderparacetamol

Kinderparacetamol CF

Kitadol

Kodipar

Kolibri

Korylan

Lanamol

Lekadol

Lemgrip

Lemsip

Lensen

Liquiprin

Lisopan

Lonarid

Lortab

Lotem

Lupocet

Lusadeina

Mafidol

Mafidol Compuesto

Maganol

Magnidol

Malex

Malidens

Mann

Medamol

Medibudget Schmerztabletten Paracetamol

Medinol

Medinol Paediatric

Medipyrin

Mejorax

Mejorax Infantil

Methoxacet

Mexalen

Midol Night-Time

Midrid

Midrone

Migraeflux MCP

Migralave + MCP

Migrane-Neuridal

Migranerton

Minafen

Minofen

Minoset

Miralgin

Momentum

Muscadol

Myogesic

Mypaid

N-Paracetamol

Nactop

Napa

Napacod

Napafen

Napamol

Naprex

Nasa

Nasamol

Nedolon

Neo Rheumacyl

Neomol

Neopap

Neopyrin

Neverdol

Niocitran

Nodipir

Nodrof

Norco

Norflex CO

Norgesic

Normotemp

Novalsung

Novo Asat

Novo-Gesic

Nufadol

Nuosic

Octadon

Omol

Optalidon Schmerztabletten

Optipyrin

Oskadon

Ottopan

Oxycet

Oxycodone and Acetaminophen

Pacimol

Painamol

Painamol Plus

Paldesic

Pamol

Pamol Flash

Panacare

Panacetamol

Panadeine

Panado

Panadol

Panadol 7+ years

Panadol Actifast

Panadol Adultos

Panadol Antigrippine

Panadol Artrose

Panadol Baby

Panadol Baby & Infant

Panadol C

Panadol Codeine

Panadol Extend

Panadol Extra

Panadol Femina

Panadol Infantil

Panadol Junior

Panadol Night

Panadol Plus

Panadol Rapide

Panadol Zapp

Panaflam

Panagesic Adultos

Panagesic Infantil

Panam Retard

Panamax

Panaram

Panasorbe

Panasorbe (Sanofi-Aventis - Produtos farmaceuticos, S.)

Panets

Panets Baby

Panodil

Panodil Zapp

Para

Para-C

Para-don

Para-G

Para-Suppo

Para-Tabs

Para-z-mol

Paracap

Paracare

Paracen

Paraceon

Paracet

Paracetam

Paracetamol / Ascorbinezuur

Paracetamol / Codeine A

Paracetamol / Codeine PCH

Paracetamol A

Paracetamol Agrand

Paracetamol AL

Paracetamol AL comp.

Paracetamol BC

Paracetamol beta

Paracetamol Brifarma

Paracetamol CF

Paracetamol Cinfamed

Paracetamol Cuve

Paracetamol DM

Paracetamol dura

Paracetamol EG

Paracetamol elac

Paracetamol Elixir

Paracetamol Extra Fort

Paracetamol Fairmed

Paracetamol FLX

Paracetamol for Chlidren

Paracetamol G Gam

Paracetamol G. E.S.

Paracetamol Grunenthal

Paracetamol Hanseler

Paracetamol HTP

Paracetamol Infantil

Paracetamol L. CH.

Paracetamol Lch

Paracetamol Lichtenstein

Paracetamol LPH

Paracetamol Merck

Paracetamol Merck

Paracetamol MK

Paracetamol PCH

Paracetamol PT Copii

Paracetamol Q-Generics

Paracetamol Ranbaxy

Paracetamol Rosch

Paracetamol Roter

Paracetamol SAD

Paracetamol SmithKline Beecham

Paracetamol Tablets

Paracetamol Therapeuticon

Paracetamol Triangle Pharma

Paracetamol Winthrop

Paracetamol Winthrop

Paracetamol Zikidis

Paracetamolis L

Paracetamolo

Paracetol

Paracin Kid Tabs.

Paracof Roter

Paracor

Paracotene

Paradex

Paradol

Paradote

Paradrops

Parafil

Parafludeten

Parafon Forte

Parageniol

Parahexal

Parakapton

Paralen

Paralgan

Paralgin

Paralief

Paralink

Paralyoc

Paramax

Paramed A. L.S.

Paramidol

Paramol

Paramolan

Paranox

Paranox-S

Parapaed

Parapyrol

Parasedol

Parasupp

Paratab

Paratabs

Paratral

Parclen

Parol

Paroma

Parox Meltab

Parsel

Paximol

Pazital

Pe-Tam

Pediatrix

Pendol

Percocet

Perdolan

Perdolan Bebe

Perdolan Codeine

Perdolan Enfant

Perfalgan

Perfalgan Kinder

Perfalgan Paediatric

Perfusalgan

Pharex Paracetamol

Pharmacare Paracetamol

Pharmadol

Phrenilin

Pinex

Pinex Comp.

Pirofen

Piros

Plicet

Plivamed

Plovacal

Pmol

PMS-Oxycodone-Acetaminophen

Polmofen

Pontalsic

Poro

Pracetam

Praxion

Prefer

Primadol

Primiza

Profenal

Progesic

Prolief

Prontopyrin

Propoxi 66

Propoxyphene Hydrochloride and Acetaminophen

Propoxyphene napsylate and Acetaminophen

Propyretic

Pyradol

Pyral

Pyralen

Pyralgin

Pyrex

Pyrexin

Pyrexon

Pyrigesic

Ramol

Rapidol

Rapidon

ratio-Emtec-30

ratio-Oxycocet

Razimol

Relaxibys

Relaxon

Reliv

Remedeine

Remedol

Reset

Resolvebohm

Revanin

Rhinofebryl

Robaxacet

Robaxisal Compuesto [+ Methocarbamol

Rokamol

Roxicet

Roxilox

Rubophen

Salzone

Sanador

Sanaflu

Sanalgin

Sanalgin N

Sanicopyrine

Sanipirina

Sanmol

Sapramol

Saridon

Scopamin Plus

Scopma Plus

Sedalito

Sedo-Febril Pediatrico

Sensamol

Servigesic

Setamol

Sifenol

Silpa

Sinalgia

Sinapol

Sinaspril Paracetamol

Singrips

Sinmol

Sinofree

Sinuclear

Sinugesic

Sinumax

Sinutab

Sinutab Sinus Non Drowsy

Sistenol

Six Plus Parapaed

Snaplets-FR

Solpadol

Spashi Plus

Spasmend

Spectrapain

Spironolactone Altizide EG

Stop Grip

Sudafed Head Cold and Sinus Extra Strength

Sudafed PE Sinus + Pain Relief

Sudafed Sinus Pain

Sudafed Sinus Pain Relief

Supofen

Supracalm

Tachiforte

Tachipirin

Tachipirina

Tafirol

Talacen

Talgo

Talgo Codeina

Talvosilen

Tamen

Tamol

Tandamol

Tapsin

Tapsin Infantil

Tazamol

Teedex

Tempil

Tempol

Tempra

Teralgex

Termacet

Termalgin

Termalgin Codeina

Termalgin Flashtab

Termalgine

Termocatil

Termofren

Tetradox

Theraflu Zatoki

Thomapyrin

Tiffy

Tilalgin Efe

Tilderol

Timidal

Tinten

Tiptipot Aldolor

Titretta

Tramacet

Tramadol hydrochloride and Acetaminophen

Tramil

Treupel

Treupel Dolo Paracetamol

Triatec-30

Trimedil

Turpan

Tydenol

Tydol

Tylenol

Tylenol Children's Decongestant

Tylenol Cough

Tylenol Kinder

Tylenol Sinus

Tylenol Ultra Relief

Tylenol with Codeine

Tylephen

Tylex

Tylol

Tylol Plus

Tylox

Ultracet

Ultracod

Ultrafen

Ultragin

Umbral

Vegantalgin

Vermidon

Vestax

Vick

Vick Vitapyrena

Vicks Paracetamol

Viclor

Vicodin

Vimergol

Vimoli

Vivimed

Volpan

Winadol

Winasorb

Witte Kruis

Woodward's Paracetamol

Xcel

Xepamol

Xpa

Xumadol

Zaldaks

Zaldiar

Zalidar Efe

Zapain

Zaramol

Zerin

Zolben

Zolben C

Zydone

Etisux, Etisux

Product Description Common use Erythromycin is in a group of drugs called macrolide antibiotics. Erythromycin is used to treat many different types of infections caused by bacteria. It is also used to prevent bacterial endocarditis and attacks of rheumatic fever.

Dosage and direction Take erythromycin exactly as it was prescribed for you. Take each dose with a full glass (8 ounces) of water. Erythromycin can be taken on an empty stomach or with food or milk. Do not crush, chew, break, or open an enteric-coated or delayed-release pill. Swallow the pill whole.

Precautions Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Contraindications Do not use this medication if you are allergic to erythromycin, or if you are also taking cisapride (Propulsid) or pimozide (Orap). If you have liver disease or myasthenia gravis, you may need a dose adjustment or special tests to safely take erythromycin. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Erythromycin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Possible side effects Get emergency medical help if you have any of these signs of an allergic reaction to erythromycin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: chest pain, uneven heartbeats, feeling light-headed or fainting; nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or diarrhea that is watery or bloody. Less serious erythromycin side effects may include: mild nausea, vomiting, diarrhea, or stomach pain; dizziness, headache, feeling tired; vaginal itching or discharge; or mild itching or skin rash.

Drug interaction Many drugs can interact with erythromycin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Missed dose Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Overdose Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, diarrhea, stomach pain, or hearing loss.

Storage Store this medication at room temperature away from moisture and heat.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. The specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Product Description Common use Erythromycin is in a group of drugs called macrolide antibiotics. Erythromycin is used to treat many different types of infections caused by bacteria. It is also used to prevent bacterial endocarditis and attacks of rheumatic fever.

Dosage and direction Take erythromycin exactly as it was prescribed for you. Take each dose with a full glass (8 ounces) of water. Erythromycin can be taken on an empty stomach or with food or milk. Do not crush, chew, break, or open an enteric-coated or delayed-release pill. Swallow the pill whole.

Precautions Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Contraindications Do not use this medication if you are allergic to erythromycin, or if you are also taking cisapride (Propulsid) or pimozide (Orap). If you have liver disease or myasthenia gravis, you may need a dose adjustment or special tests to safely take erythromycin. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Erythromycin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Possible side effects Get emergency medical help if you have any of these signs of an allergic reaction to erythromycin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: chest pain, uneven heartbeats, feeling light-headed or fainting; nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or diarrhea that is watery or bloody. Less serious erythromycin side effects may include: mild nausea, vomiting, diarrhea, or stomach pain; dizziness, headache, feeling tired; vaginal itching or discharge; or mild itching or skin rash.

Drug interaction Many drugs can interact with erythromycin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Missed dose Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Overdose Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, diarrhea, stomach pain, or hearing loss.

Storage Store this medication at room temperature away from moisture and heat.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. The specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Product Description Common use Erythromycin is in a group of drugs called macrolide antibiotics. Erythromycin is used to treat many different types of infections caused by bacteria. It is also used to prevent bacterial endocarditis and attacks of rheumatic fever.

Dosage and direction Take erythromycin exactly as it was prescribed for you. Take each dose with a full glass (8 ounces) of water. Erythromycin can be taken on an empty stomach or with food or milk. Do not crush, chew, break, or open an enteric-coated or delayed-release pill. Swallow the pill whole.

Precautions Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Contraindications Do not use this medication if you are allergic to erythromycin, or if you are also taking cisapride (Propulsid) or pimozide (Orap). If you have liver disease or myasthenia gravis, you may need a dose adjustment or special tests to safely take erythromycin. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Erythromycin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Possible side effects Get emergency medical help if you have any of these signs of an allergic reaction to erythromycin: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: chest pain, uneven heartbeats, feeling light-headed or fainting; nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or diarrhea that is watery or bloody. Less serious erythromycin side effects may include: mild nausea, vomiting, diarrhea, or stomach pain; dizziness, headache, feeling tired; vaginal itching or discharge; or mild itching or skin rash.

Drug interaction Many drugs can interact with erythromycin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Missed dose Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Overdose Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, diarrhea, stomach pain, or hearing loss.

Storage Store this medication at room temperature away from moisture and heat.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. The specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Lithium Carbonate - Fda Prescribing Information, Side Effects And Uses, Lithii

Lithium Carbonate

Lithium Carbonate CAPSULES, USP Rev. 10/15 Rx Only

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels. Facilities for prompt and accurate serum lithium determinations should be available before initiating therapy (see DOSAGE AND ADMINISTRATION ).

Lithium Carbonate Description

Each capsule for oral administration contains 150 mg, 300 mg or 600 mg of Lithium Carbonate. In addition, each capsule contains the following inactive ingredient:

600 mg: Colloidal Silicon Dioxide, Stearic Acid and Talc.

Capsule shell for the 150 mg potency contains: Gelatin and Titanium Dioxide.

Capsule shell for the 300 mg potency contains: D&C Yellow #10, FD&C Green #3, FD&C Red #40, FD&C Yellow #6, Gelatin and Titanium Dioxide.

Capsule shell for the 600 mg potency contains: Titanium Dioxide, Gelatin and FD&C Red #40.

The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol, and Synthetic Black Iron Oxide.

Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94, and an emission line at 671 nm on the flame photometer.

Lithium Carbonate is a white, light, alkaline powder with molecular formula Li 2 CO 3 and molecular weight 73.89.

Lithium Carbonate - Clinical Pharmacology

Preclinical studies have shown that lithium alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of lithium action in mania is unknown.

Indications and Usage for Lithium Carbonate

Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology.

Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder.

Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur.

Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.

Contraindications

Lithium should generally not be given to patients with significant renal or cardiovascular disease, severe debilitation or dehydration, or sodium depletion, and to patients receiving diuretics, since the risk of lithium toxicity is very high in such patients. If the psychiatric indication is life-threatening, and if such a patient fails to respond to other measures, lithium treatment may be undertaken with extreme caution, including daily serum lithium determinations and adjustment to the usually low doses ordinarily tolerated by these individuals. In such instances, hospitalization is a necessity.

Warnings

Lithium toxicity is closely related to serum lithium levels, and can occur at doses close to therapeutic levels (see DOSAGE AND ADMINISTRATION ).

Unmasking of Brugada Syndrome:

There have been postmarketing reports of a possible association between treatment with lithium and the unmasking of Brugada Syndrome. Brugada Syndrome is a disorder characterized by abnormal electrocardiographic (ECG) findings and a risk of sudden death. Lithium should generally be avoided in patients with Brugada Syndrome or those suspected of having Brugada Syndrome. Consultation with a cardiologist is recommended if: (1) treatment with lithium is under consideration for patients suspected of having Brugada Syndrome or patients who have risk factors for Brugada Syndrome, e. g. unexplained syncope, a family history of Brugada Syndrome, or a family history of sudden unexplained death before the age of 45 years, (2) patients who develop unexplained syncope or palpitations after starting lithium therapy.

Pregnancy:

Lithium may cause fetal harm when administered to a pregnant woman. There have been reports of lithium having adverse effects on nidations in rats, embryo viability in mice, and metabolism in vitro of rat testis and human spermatozoa have been attributed to lithium, as have teratogenicity in submammalian species and cleft palates in mice. Studies in rats, rabbits and monkeys have shown no evidence of lithium-induced teratology. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebstein’s anomaly. If the patient becomes pregnant while taking lithium, she should be apprised of the potential risk to the fetus. If possible, lithium should be withdrawn for at least the first trimester unless it is determined that this would seriously endanger the mother.

Lithium-Induced Renal Effects:

Chronic lithium therapy may be associated with diminution of renal concentrating ability, occasionally presenting as nephrogenic diabetes insipidus, with polyuria and polydipsia. Such patients should be carefully managed to avoid dehydration with resulting lithium retention and toxicity. This condition is usually reversible when lithium is discontinued.

Morphologic changes with glomerular and interstitial fibrosis and nephron-atrophy have been reported in patients on chronic lithium therapy. Morphologic changes have also been seen in bipolar patients never exposed to lithium. The relationship between renal functional and morphologic changes and their association with lithium therapy has not been established.

When kidney function is assessed, for baseline data prior to starting lithium therapy or thereafter, routine urinalysis and other tests may be used to evaluate tubular function (e. g. urine specific gravity or osmolality following a period of water deprivation, or 24-hour urine volume) and glomerular function (e. g. serum creatinine or creatinine clearance). During lithium therapy, progressive or sudden changes in renal function, even within the normal range, indicate the need for reevaluation of treatment.

Precautions

General:

The ability to tolerate lithium is greater during the acute manic phase and decreases when manic symptoms subside (see DOSAGE AND ADMINISTRATION ).

The distribution space of lithium approximates that of total body water. Lithium is primarily excreted in urine with insignificant excretion in feces. Renal excretion of lithium is proportional to its plasma concentration. The half-life of elimination of lithium is approximately 24 hours. Lithium decreases sodium reabsorption by the renal tubules which could lead to sodium depletion. Therefore, it is essential for the patient to maintain a normal diet, including salt, and an adequate fluid intake (2500-3000 mL) at least during the initial stabilization period. Decreased tolerance to lithium has been reported to ensue from protracted sweating or diarrhea and, if such occur, supplemental fluid and salt should be administered.

In addition to sweating and diarrhea, concomitant infection with elevated temperatures may also necessitate a temporary reduction or cessation of medication.

Previously existing underlying thyroid disorders do not necessarily constitute a contraindication to lithium treatment; where hypothyroidism exists, careful monitoring of thyroid function during lithium stabilization and maintenance allows for correction of changing thyroid parameters, if any. Where hypothyroidism occurs during lithium stabilization and maintenance, supplemental thyroid treatment may be used.

Information for the Patients:

A condition known as Brugada Syndrome may pre-exist and be unmasked by lithium therapy. Brugada Syndrome is a heart disorder characterized by abnormal electrocardiographic (ECG) findings and risk of sudden death. Patients should be advised to seek immediate emergency assistance if they experience fainting, lightheadedness, abnormal heart beats, or shortness of breath.

Outpatients and their families should be warned that the patient must discontinue lithium therapy and contact his physician if such clinical signs of lithium toxicity as diarrhea, vomiting, tremor, mild ataxia, drowsiness, or muscular weakness occur.

Lithium may impair mental and/or physical abilities. Caution patients about activities requiring alertness (e. g. operating vehicles or machinery).

Drug Interactions:

Combined use of haloperidol and lithium: An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) followed by irreversible brain damage has occurred in a few patients treated with lithium plus haloperidol. A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.

The possibility of similar adverse interactions with other antipsychotic medication exists.

Lithium may prolong the effects of neuromuscular blocking agents. Therefore, neuromuscular blocking agents should be given with caution to patients receiving lithium.

Caution should be used when lithium and diuretics or angiotensin converting enzyme (ACE) inhibitors are used concomitantly because sodium loss may reduce the renal clearance of lithium and increase serum lithium levels with risk of lithium toxicity. When such combinations are used, the lithium dosage may need to be decreased, and more frequent monitoring of lithium plasma levels is recommended.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDS): Lithium levels should be closely monitored when patients initiate or discontinue NSAID use. In some cases, lithium toxicity has resulted from interactions between an NSAID and lithium. Indomethacin and piroxicam have been reported to increase significantly steady-state plasma lithium concentrations. There is also evidence that other non-steroidal anti-inflammatory agents, including the selective cyclooxygenase-2 (COX-2) inhibitors, have the same effect. In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg BID with celecoxib 200 mg BID as compared to subjects receiving lithium alone.

Pregnancy, Teratogeni c Effects: Pregnancy Category D: See WARNINGS section.

Nursing Mothers:

Lithium is excreted in human milk. Nursing should not be undertaken during lithium therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazards to the child.

Usage in Children :

Since information regarding the safety and effectiveness of lithium in children under 12 years of age is not available, its use in such patients is not recommended at this time. There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg child who ingested 300 mg of Lithium Carbonate.

Adverse Reactions

Lithium Toxicity: The likelihood of toxicity increases with increasing serum lithium levels. Serum lithium levels greater than 1.5 mEq/L carry a greater risk than lower levels. However, patients sensitive to lithium may exhibit toxic signs at serum levels below 1.5 mEq/L.

Diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination may be early signs of lithium toxicity, and can occur at lithium levels below 2 mEq/L. At higher levels, giddiness, ataxia, blurred vision, tinnitus and a large output of dilute urine may be seen. Serum lithium levels above 3 mEq/L may produce a complex clinical picture involving multiple organs and organ systems. Serum lithium levels should not be permitted to exceed 2 mEq/L during the acute treatment phase.

Fine hand tremor, polyuria and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of lithium administration.

These side effects are an inconvenience rather than a disabling condition, and usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, a cessation of dosage is indicated.

The following adverse reactions have been reported and do not appear to be directly related to serum lithium levels.

Neuromuscular: Tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), ataxia, choreo-athetotic movements, hyperactive deep tendon reflexes.

Central Nervous System: Blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, acute dystonia, downbeat nystagmus.

Cardiovascular: Cardiac arrhythmia, hypotension, peripheral circulatory collapse, sinus node dysfunction with severe bradycardia (which may result in syncope), unmasking of Brugada Syndrome (See WARNINGS: Unmasking of Brugada Syndrome and PRECAUTIONS: Information for the Patients ).

Neurological: Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with lithium use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy. Lithium should be discontinued, if clinically possible, if this syndrome occurs.

Gastrointestinal: Anorexia, nausea, vomiting, diarrhea.

Genitourinary: Albuminuria, oliguria, polyuria, glycosuria.

Dermatologic: Drying and thinning of hair, anesthesia of skin, chronic folliculitis, xerosis cutis, alopecia and exacerbation of psoriasis.

Autonomic Nervous System: Blurred vision, dry mouth.

Thyroid Abnormalities: Euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T 3 and T 4. Iodine 131 uptake may be elevated. (See PRECAUTIONS ). Paradoxically, rare cases of hyperthyroidism have been reported.

EEG Changes: Diffuse slowing, widening of frequency spectrum, potentiation and disorganization of background rhythm.

EKG Changes: Reversible flattening, isoelectricity or inversion of T-waves.

Miscellaneous: Fatigue, lethargy, transient scotomata, dehydration, weight loss, tendency to sleep.

Miscellaneous R eactions U nrelated to D osage are: Transient electroencephalographic and electrocardiographic changes, leukocytosis, headache, diffuse non-toxic goiter with or without hypothyroidism, transient hyperglycemia, generalized pruritus with or without rash, cutaneous ulcers, albuminuria, worsening of organic brain syndromes, excessive weight gain, edematous swelling of ankles or wrists, and thirst or polyuria, sometimes resembling diabetes insipidus, and metallic taste.

A single report has been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment of lithium. The mechanism through which these symptoms (resembling Raynaud’s Syndrome) developed is not known. Recovery followed discontinuance.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-233-2001, or FDA at 1-800-FDA-1088 or www. fda. gov/medwatch.

Overdosage

The toxic levels for lithium are close to the therapeutic levels. It is therefore important that patients and their families be cautioned to watch for early symptoms and to discontinue the drug and inform the physician should they occur. Toxic symptoms are listed in detail under ADVERSE REACTIONS .

No specific antidote for lithium poisoning is known. Early symptoms of lithium toxicity can usually be treated by reduction or cessation of dosage of the drug and resumption of the treatment at a lower dose after 24 to 48 hours. In severe cases of lithium poisoning, the first and foremost goal of treatment consists of elimination of this ion from the patient.

Treatment is essentially the same as that used in barbiturate poisoning: 1) gastric lavage, 2) correction of fluid and electrolyte imbalance and 3) regulation of kidney functioning. Urea, mannitol and aminophylline all produce significant increases in lithium excretion. Hemodialysis is an effective and rapid means of removing the ion from the severely toxic patient. Infection prophylaxis, regular chest X-rays, and preservation of adequate respiration are essential.

Lithium Carbonate Dosage and Administration

Acute Mania – Optimal patient response to Lithium Carbonate usually can be established and maintained with 600 mg t. i.d. Such doses will normally produce an effective serum lithium level ranging between 1 and 1.5 mEq/L. Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient’s clinical state and of serum lithium levels is necessary. Serum levels should be determined twice per week during the acute phase, and until the serum level and clinical condition of the patient have been stabilized.

Long-Term Control – The desirable serum lithium levels are 0.6 to 1.2 mEq/L. Dosage will vary from one individual to another, but usually 300 mg of Lithium Carbonate t. i.d. or q. i.d. will maintain this level. Serum lithium levels in uncomplicated cases receiving maintenance therapy during remission should be monitored at least every two months.

Patients abnormally sensitive to lithium may exhibit toxic signs at serum levels of 1 to 1.5 mEq/L. Elderly patients often respond to reduced dosage, and may exhibit signs of toxicity at serum levels ordinarily tolerated by other patients.

N. B. Blood samples for serum lithium determination should be drawn immediately prior to the next dose when lithium concentrations are relatively stable (i. e. 8-12 hours after the previous dose). Total reliance must not be placed on serum levels alone. Accurate patient evaluation requires both clinical and laboratory analysis.

How is Lithium Carbonate Supplied

Lithium Carbonate Capsules, USP 150 mg are supplied as No. 4 White/White Opaque Hard Gelatin Capsules Printed “West-ward 3188” in Black Ink and are available in: Bottles of 30 capsules Bottles of 100 capsules Bottles of 500 capsules

Lithium Carbonate Capsules, USP 300 mg are supplied as No. 1 Grey/Yellow Opaque Hard Gelatin Capsules Printed “West-ward 3189” in Black Ink and are available in: Bottles of 100 capsules Bottles of 500 capsules Bottles of 1000 capsules

Lithium Carbonate Capsules, USP 600 mg are supplied as No. 0 Elongated White/Flesh Opaque Capsules Printed “West-ward 3190” in Black Ink and are available in: Bottles of 100 capsules

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured By: West - W ard Pharmaceutical s Corp. Eatontown, NJ 07724 Revised October 2015

PRINCIPAL DISPLAY PANEL

NDC 0143-3188-01 Lithium Carbonate Capsules, USP 150 mg 100 capsules Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0143-3189-01 Lithium Carbonate Capsules, USP 300 mg 100 capsules Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0143-3190-01 Lithium Carbonate Capsules, USP 600 mg 100 capsules Rx Only

Erythromycine, Erythromycine

Livertox

Introduction

Erythromycin is an oral macrolide antibiotic that has been in common use since the 1950s. Erythromycin has been linked to rare instances of acute liver injury that are usually self-limited, but can result in severe injury and death.

Background

Erythromycin (e rith" roe mye' sin) is a semisynthetic macrolide antibiotic used widely for many decades to treat mild-to-moderate bacterial infections caused by sensitive agents. Erythromycin is bacteriostatic against many gram positive bacteria including many strains of streptococci, staphylococci, clostridia, corynebacteria, listeria, haemophilus sp. moxicella, and Neisseria meningitidis. Modifications of erythromycin have been developed with a wider range of activity and less likelihood for resistance (azithromycin, clarithromycin, telithromycin). The macrolide antibiotics are believed to act by inhibiting protein synthesis of bacteria by binding to the 50S ribosomal element. Resistance occurs by several mechanisms. Erythromycin was approved for use in the United States in 1967, and currently more than 1.5 million prescriptions are filled yearly. Specific indications include mild-to-moderate upper or lower respiratory tract infections, urethritis, pelvic inflammatory disease, urogenital chlamydia infections, Legionnaires’ disease, and intestinal amebiasis. Erythromycin is commonly used as a second-line agent when penicillin, tetracyclines or metronidazole are contraindicated. Erythromycin is available in multiple formulations (estolate, ethylsuccinate, lactobionate, stearate) in many generic and brand name forms in capsules or tablets of 250 or 500 mg including enteric coated and delayed release forms. The usual adult dose is 1 to 4 grams daily in divided doses for 7 to 21 days, depending upon the type, nature and severity of the infection. Gastrointestinal side effects (abdominal pain, nausea, and diarrhea) are common, but are rarely severe.

Hepatotoxicity

Erythromycin therapy is associated with a low rate (1% to 2%) of serum enzyme elevations during therapy. The enzyme elevations are typically asymptomatic and transient, and may occur no more frequently than with placebo or other comparator anitbiotic treatments.

Clinically apparent liver injury from erythromycin is rare, but because of the frequency of its use, erythromycin has been one of the most common causes of drug induced liver injury at least in previous years. Initially, liver injury was thought to be more common with, or perhaps limited to, erythromycin estolate. However, instances of jaundice and liver damage have been reported with virtually all formulations of erythromycin, and cross sensitivity to injury is common, although not universal. The hepatotoxicity of erythromycin resembles that described in other macrolide antibiotics and is typically a mild and self-limiting cholestatic hepatitis. The latency period between starting erythromycin and onset of liver injury is short, typically 1 to 3 weeks and is shorter (<1 week) with reexposure. Symptoms may include right upper quadrant pain and jaundice, clinical features that might suggest cholecystitis. Eosinophilia and fever are common, but not universal; rash is reported less commonly. The pattern of enzyme elevations is often mixed or variable, but the disease is usually cholestatic and symptoms of pruritus may be prominent. The liver injury is usually mild and self-limited with recovery in 4 to 8 weeks. However, instances of prolonged jaundice and cholestasis with paucity of bile ducts due to erythromycin have been reported. Furthermore, cases of abupt onset of liver injury after a short latency (<1 week) and a hepatocellular pattern of liver enzyme elevations have been reported, particularly with repeat exposure, and some of these cases have led to acute liver failure and death or need for liver transplantation. Rapid recurrence occurs with rechallenge even within 24 hours of a single dose.

A separate syndrome associated with erythromycin use is acute right upper quadrant pain without jaundice that arises within a day or two of starting therapy. Serum enzymes may be mildly elevated, usually in a hepatocellular pattern and with rapid recovery once erythromycin is stopped.

Mechanism of Injury

The cause of the idiosyncratic hepatitis following erythromycin therapy is not known. Allergic manifestations (rash, fever and eosinophilia) are typical, so that hypersensitivity is assumed to be the cause. Other features suggesting hypersensitivity are that rechallenge typically leads to recurrence with a shortened latency period, and patients may have a history of previous exposure to erythromycins without adverse effects.

Outcome and Management

Most cases of erythromycin induced liver disease are mild and self-limiting; however, very rare instances of severe acute hepatic injury leading to acute liver failure and need for transplantation or death have been described. Furthermore, isolated examples of prolonged cholestasis with vanishing bile duct syndrome have been reported. Patients with erythromycin induced hepatic injury should be cautioned to avoid further exposure and it is prudent to avoid use of other macrolides in patients with clinically apparent liver injury due to erythromycin.

Drug Class: Antiinfective Agents. Macrolide Antibiotics

Case 1. Abdominal pain and jaundice after erythromycin therapy. (Modified from: Reed C, Ritchie F. Toxic jaundice due to propionyl erythromycin ester lauryl sulfate (“Ilosone”). Med J Aust 1962; 49: 810-2. PubMed Citation

A 33 year old man with a superficial cellulitis on his hand was treated with erythromycin estolate in January 1961 and again in March. Within 10 days of starting the second course, he developed right upper quadrant abdominal pain followed by dark urine and jaundice. With stopping the drug, he improved rapidly, the pain and jaundice clearing within days (Table) and ALT levels falling to normal over the next two months. In October of the same year, he restarted erythromycin for a recurrence of the cellulitis and developed severe abdominal pain within the next day, followed shortly afterwards by jaundice and dark urine. Therapy was stopped after 2 days when he was found to be jaundiced. Again, recovery was rapid. During both episodes, there was no rash, fever, arthralgias or eosinophilia. Testing for autoantibodies was not mentioned in the report, which predated tests for hepatitis A, B and C.

Key Points

Erythromycin estolate (250 mg four times daily)

* KA U = King Armstrong Units

Comment

A very convincing example of erythromycin hepatotoxicity, with symptoms arising 10 days after a second exposure to the medication and then within 24 hours of the inadvertent rechallenge 6 months later. Abdominal pain is a common presenting symptom in macrolide associated acute hepatic injury. The two episodes were mirror images in pattern and height of enzyme and bilirubin elevations. The course suggests an immunoallergic mechanism of injury, even though rash, fever and eosinophilia were absent. The symptoms and high ALT levels are typical of hepatocellular injury; but, erythromycin is classically believed to lead to cholestatic hepatitis; this example demonstrating that serum enzymes in hyperacute cases are more typically hepatocellular in pattern.

Case 2. Asymptomatic liver injury after one day of erythromycin. (Modified from: Alcalay J, Halevy S, Theodor E, Sandbank M. Asymptomatic liver injury due to erythromycin stearate. Drug Intell Clin Pharm 1986; 20: 601-2. PubMed Citation

A 73 year old woman was started on erythromycin stearate just before being admitted for evaluation of facial pyoderma, but was then found to have abnormal liver tests with elevations in both alkaline phosphatase and ALT (Table). Serum enzyme levels continued to climb and erythromycin was stopped, whereupon levels fell into the normal range. During the whole period, she was asymptomatic and specifically denied fatigue, nausea, abdominal pain or dark urine. Serum bilirubin levels remained normal.

Key Points

* Some values estimated from Figure 1. Bilirubin converted from µmol (1.0 mg% = 17.1 µmol).

Comment

This case was unusual in several regards. First, the latency period was short, particularly for a patient who had not received erythromycin in the past. Second, the enzyme pattern was cholestatic, but there was no jaundice or symptoms. Erythromycin typically causes a syndrome of sudden onset of right upper quadrant pain, fever and jaundice. Jaundice from erythromycin is usually mild, but can occasionally be severe and prolonged. This is one of the few cases of acute erythromycin induced liver disease published in the last 25 years. This form of drug induced liver injury appears to be less common with the non-estolate forms of erythromycin, and there is a general lack of interest in publishing cases of hepatotoxicity due to drugs well known to be associated with liver injury.

Case 3. Acute hepatitis from erythromycin. [Modified from a case in the database of the Drug-Induced Liver Injury Network.]

A 73 year old woman developed right flank pain and fever 2 to 3 days after starting erythromycin ethylsuccinate (400 mg four times daily) for symptoms of cystitis. She stopped erythromycin promptly, but developed increasing fatigue, jaundice and pruritus over the next few days and presented to her physician 4 days later. She did not drink alcohol and had no history of liver disease or risk factors for viral hepatitis. Her other medications included atorvastatin and aspirin which she had taken for many years. She had been treated with erythromycin six months previously, but without adverse effects. On admission, her serum bilirubin was 8.6 mg/dL, ALT 1884 U/L, AST 1574 U/L, alkaline phosphatase 492 U/L, serum albumin 3.2 g/dL and INR 0.85 (Table). Tests for hepatitis A, B and C were negative. Antinuclear antibody was negative, while smooth muscle antibodies were weakly positive (1:80). Abdominal ultrasound, computerized tomography and magnetic resonance cholangiopancreatography demonstrated a single large gallstone, but no evidence of biliary obstruction. She was monitored on no specific therapy and liver test abnormalities slowly improved. Symptoms resolved within two weeks, serum bilirubin fell to normal within one month and all liver tests were normal when she was seen in follow up 3 months later. Atorvastatin, which had been stopped with the onset of jaundice, was restarted without recurrence of liver injury.

Key Points

Erythromycin ethylsuccinate (400 mg four times daily) for two days

Comment

The appearance of liver injury and jaundice within a week of starting erythromycin is typical of the acute onset of injury with rechallenge. This patient had taken erythromycin in the past without difficulty, but the previous exposure may have resulted in a sensitization that became clinically manifest with reexposure. The serum enzyme elevations were hepatocellular with marked increases in serum ALT and AST (40-50 times normal). However, the alkaline phosphatase was also elevated (3- to 5-fold) and she complained of pruritus during the acute episode, suggesting a cholestatic element to the injury. Erythromycin hepatotoxicity appears to be more common in older individuals. The acute, abrupt hepatocellular injury with macrolide antibiotics can be severe and lead to acute liver failure. The prompt discontinuation of the medication may have been fortunate.

PRODUCT INFORMATION Erythromycin

REPRESENTATIVE TRADE NAMES Erythromycin — Generic, ERYC®

DRUG CLASS Antiinfective Agents

Product labeling at DailyMed, National Library of Medicine, NIH

CAS REGISTRY NUMBER

References updated: 04 April 2014

Zimmerman HJ. Erythromycins. In, Zimmerman HJ. Hepatotoxicity: The adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott Williams & Wilkins, 1999, pp. 594-5. (Expert review of erythromycin and liver injury published in 1999; erythromycin has been linked to many instances of cholestatic hepatitis typically presenting after 1-3 weeks of therapy [initial exposure] but sometimes within a week of starting treatment [repeat exposure] with abdominal pain [75%], jaundice [75%], fever [50%], eosinophilia [60%], and pruritus [25%], most cases being self-limiting and benign).

Moseley RH. Macrolide antibiotics. Hepatotoxicity of antimicrobials and antifungal agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced Liver Disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 466-7. (Expert review of macrolide antibiotic-induced liver injury mentions that liver injury from erythromycin is typically cholestatic and usually self-limited, occurring in 3-4 persons per 100,000 users; now rarely reported).

MacDougall C, Chambers HF. Macrolides and ketolides. In, Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 12th ed. New York: McGraw-Hill, 2011, pp. 1529-34. (Textbook of pharmacology and therapeutics).

Johnson DF Jr, Hall WH. Allergic hepatitis caused by propionyl erythromycin ester of lauryl sulfate. N Engl J Med 1961; 265: 1200-2. PubMed Citation (Onset of fever and right upper quadrant pain after 12 days of erythromycin estolate [bilirubin 1.8 mg/dL, AST 117 U/L]; re-exposure caused immediate recurrence with pain [bilirubin 3.0 mg/dL, AST 320 U/L, Alk P 5 times ULN] but full subsequent recovery).

Kohlstaedt KG. Propionyl erythromycin ester lauryl sulfate and jaundice. JAMA 1961; 178: 89-90. (Letter describing 7 cases reported to Eli Lilly of jaundice, AST elevations (100-300 U/L), eosinophilia, and elevated Alk P levels after erythromycin use; 4 had positive rechallenge with pain and jaundice; after 3 years of availability, a total of 33 cases of liver injury were reported after an estimated 15 million courses:

Dittler EL. Upper abdominal pain and intrahepatic cholestasis as manifestations of sensitivity to Ilosone. Am J Gastroenterol 1962; 38: 691-2. PubMed Citation (50 year old woman had three episodes of right upper quadrant pain, fever, Alk P and ALT elevations after single erythromycin estolate ingestion: no jaundice, but few tablets taken).

Gilbert FI Jr. Cholestatic hepatitis caused by esters of erythromycin and oleandomycin. JAMA 1962; 182: 1048-50. PubMed Citation (46 year old man developed severe right upper quadrant pain and fever 12 hours after taking 2 doses of erythromycin estolate [bilirubin 2.4 mg/dL, AST 350 U/L, Alk P 4.7 BU], but subsequently had no reaction to one challenge dose of erythromycin stearate).

Havens WP Jr. Cholestatic jaundice in patients treated with erythromycin estolate. JAMA 1962; 180: 30-2. PubMed Citation (Report of 4 patients [ages 19-59 years, 3 men and 1 woman] with erythromycin hepatitis, latency to onset of 1-3 weeks presenting with jaundice, itching, fever and abdominal pain, 3 with eosinophilia; mixed, cholestatic and hepatocellular patterns of enzyme elevations, 3 treated with prednisone, 1 had severe and prolonged course beyond 6 months).

Masel MA. Erythromycin hepato-sensitivity: a preliminary report of two cases. Med J Aust 1962; 49: 560-2. PubMed Citation (Two cases: 12 and 17 year old boys developed acute liver injury 11 and 17 days after starting erythromycin therapy with fever, rash, abdominal pain, jaundice [bilirubin 6.5 and 5.4 mg/dL] and eosinophilia with rapid recovery).

Reed C, Ritchie F. Toxic jaundice due to propionyl erythromycin ester lauryl sulfate (“Ilosone”). Med J Aust 1962; 49: 810-2. PubMed Citation (33 year old man developed abdominal pain 10 days after starting erythromycin [2nd exposure] with subsequent jaundice [bilirubin 4.7 mg/dL, ALT 3000 U/L, Alk P normal], and an immediate recurrence after a single dose 6 months later; rapid recovery after both episodes: Case 1).

Riley WA. Hepatitis following administration of Ilosome. Case report. N C Med J 1962; 23: 362. PubMed Citation (23 year old man developed fatigue after 5 days of oral erythromycin, with subsequent jaundice [bilirubin 9.6 mg/dL], resolving within a month of stopping; no serum enzyme results; had a positive rechallenge).

Robinson MM. Demonstration by "challenge" of hepatic dysfunction associated with propionyl erythromycin ester lauryl sulfate. Antibiot Chemother 1962; 12: 147-51. PubMed Citation (Follow up study, triacetyloleandomycin led to raised ALT in 11 of 59 patients treated for more than 14 days; rechallenge in 3 led to increases in ALT to 340, 81 and 274 U/L with eosinophilia [6-11%] but no jaundice).

Robinson MM. Hepatic dysfunction associated with triacetyloleandomycin and propionyl erythromycin ester lauryl sulfate. Am J Med Sci 1962; 243: 502-10. PubMed Citation (Prospective study of 80 patients receiving erythromycin estolate, 10 developed raised ALT [67-300 U/L] within 14-21 days, 2 had jaundice [2.2 and 3.5 mg/dL], all resolved with stopping but 3/3 had ALT rise [180-2060 U/L] and eosinophilia within 24 hours of rechallenge).

Robinson MM. Hepatic dysfunction associated with triacetyloleandomycin demonstrated by challenge. Am J Med Sci 1962; 244: 221-4. PubMed Citation (Follow up study, triacetyloleandomycin led to raised ALT in 11 of 59 patients treated for more than 14 days; rechallenge in 3 led to increases in ALT to 340, 81 and 274 U/L with eosinophilia [6-11%] but no jaundice).

Brown AR. Two cases of untoward reaction after "Ilosone". Br Med J 1963; 2: 913-5. PubMed Citation (2 case reports from Australia: 25 year old man developed fever, severe right upper quadrant pain and jaundice that persisted for 3 months after 2nd day of a second 3-day course of erythromycin estolate; 51 year old woman developed acute right upper quadrant pain after single dose of erythromycin [bilirubin normal, AST 95 U/L, Alk P 22 KA U/L], resolving within 3 weeks).

Farmer CD, Hoffman HN 2nd, Shorter RG, Thurber DL, Bartholomew LG. Intrahepatic cholestasis associated with the ingestion of erythromycin estolate (Ilosone). Gastroenterology 1963; 45: 158-60. PubMed Citation (6 cases of erythromycin hepatotoxicity from Mayo Clinic with onset after 6-21 days, usually presenting with abdominal pain and fever but mild jaundice, rapid recovery; 2 patients had previous exposures, 1 had positive rechallenge).

Ticktin HE, Robinson MM. Effects of some antimicrobial agents on the liver. Ann NY Acad Sci 1963; 104: 1080-92. (Not in PubMed).

Fischer HW, Hoak JC. Mimicry of acute cholecystitis by erythromycin estolate reactions. Report of 2 cases. Am J Med Sci 1964; 247: 283-5. PubMed Citation (Two men (ages 42 and 53 years] developed acute right upper quadrant pain after 4 and 2 days of oral erythromycin with minimal ALT increase and no jaundice or gallstones, 1 had rapid recurrence with rechallenge).

Fukayak TG. [Case of hypersensitive hepatitis due to propionyl erythromycin lauryl sulfate] Naika 1964; 14: 741-4. Japanese. PubMed Citation

Nilsson S. [Liver disorders due to treatment with propionyl-erythromycin-lauryl sulfate (Ilosone)] Nord Med 1964; 72: 1417-9. Swedish. PubMed Citation

Herskovic T, Solis J, Villasana Z, Jinich H. Acute abdomen associated with the ingestion of erythromycin estolate. Am J Gastoenterol 1965; 43: 138-142.

McKenzie I, Doyle A. Two cases of jaundice following "Ilosone". Med J Aust 1966; 1: 349-51. PubMed Citation (Two cases: 40 and 21 year old men developed jaundice after 4 and 8 days of therapy with erythromycin estolate [bilirubin 6 and 12 mg/L, AST 80 and 87 U/L, Alk P 47 and 15 U/L], with slow recovery [1 and 6 months]).

Petricevic I, Kosutic Z, Schonwald S, Rulnjevic J. [Hepatitis caused by erythromycin] Lijec Vjesn 1968; 90: 1051-9. Croatian. PubMed Citation

Braun P. Hepatotoxicity of erythromycin. J Infect Dis 1969; 119: 300-6. PubMed Citation (Thorough review of literature on hepatotoxicity of macrolides up to 1969: by then, there were 45 published cases of liver injury from erythromycin estolate [none with stearate] presenting within 1-3 weeks with jaundice [67%], abdominal pain, nausea and fever [

50%] as well as eosinophilia [62%], elevations in ALT [100%: average 338 U/L] and Alk P [51%]; 13 rechallenged, invariably followed by rapid recurrence, often severe])

Kosenow W, Stollenwerk F. [Jaundice following erythromycin-estolate therapy] Dtsch Med Wochenschr 1971; 96: 1836 passim. German. PubMed Citation

Oliver LE, Iser JH, Stening GF, Smallwood RA. Abdominal pain and erythromycin estolate. Lancet 1972; 2: 980. PubMed Citation (Letter describing 5 cases of severe right upper quadrant pain within 4-36 hours of taking erythromycin estolate, 2 with jaundice).

The erythromycins. A further report from the Australian Drug Evaluation Committee. Med J Aust 1973; 2: 192-3. PubMed Citation (As of May 1973, 113 cases of jaundice due to erythromycin estolate had been reported to Australian registry; all ages affected, mostly within 14 days, but some >21 days of starting, usually lasting < 28 days, no deaths).

[Erythromycin estolate and liver toxicity] Ugeskr Laeger 1974; 136: 2093-4. Danish. PubMed Citation

Buchanec J, Krajnak V. [Liver damage during erythromycin therapy in 3 children] Cesk Pediatr 1974; 29: 76-8. Slovak. PubMed Citation

Tolman KG, Sannella JJ, Freston JW. Chemical structure of erythromycin and hepatotoxicity. Ann Intern Med 1974; 81: 58-60. PubMed Citation (Patient with erythromycin estolate hepatotoxicity was rechallenged with various erythromycins: rapid recurrence after estolate [temp 39.9° C, bilirubin 2.3 mg/dL, ALT 608 U/L], within 5 days and after propionate [temp 38.4° C, bilirubin 1.7 mg/dL, ALT 326 U/L] but no recurrence after stearate, ethylsuccinate or erythromycin-base rechallenges).

Lunzer MR, Huang SN, Ward KM, Sherlock S. Jaundice due to erythromycin estolate. Gastroenterology 1975; 68(5 Pt 1): 1284-91. PubMed Citation (43 year old man developed right upper quadrant pain 24 hours after starting a second course of erythromycin estolate followed by jaundice; rechallenged and redeveloped pain [AST rising from 12 to 302 U/L, Alk P 11 to 22 KA U, bilirubin 0.5 to 1.3 mg/dL]: biopsy before and after rechallenge showed inflammation and endoplasmic reticulum changes by electron microscopy without necrosis).

Pessayre D, Marie C, Benhamou JP. [Hepatitis due to erythromycin propionate (author's transl)] Arch Fr Mal App Dig 1976; 65: 405-8. French. PubMed Citation (Cholestatic jaundice with right upper quadrant pain and eosinophilia, resolving with stopping erythromycin propionate and recurring with rechallenge).

Cacace LG, Schweigert BF, Gildon AM. Erythromycin estolate induced hepatotoxicity: report of a case and review of the literature. Drug Intell Clin Pharm 1977; 11: 22-25. Not in PubMed.

Cooksley WG, Powell LW. Erythromycin jaundice: diagnosis by an in vitro challenge test. Aust N Z J Med 1977; 7: 291-3. PubMed Citation (53 year old woman developed fever within 24 hours and jaundice within 4 days of taking 2 capsules of erythromycin estolate [bilirubin 17.1 mg/dL, AST 69 U/L, Alk P 114 U/L] and recovery in

3 weeks; lymphocyte transformation tests was positive 2 years later to estolate but not stearate or erythromycin base).

McCormack WM, George H, Donner A, Kodgis LF, Alpert S, Lowe EW, Kass EH. Hepatotoxicity of erythromycin estolate during pregnancy. Antimicrob Agents Chemother 1977; 12: 630-5. PubMed Citation (Prospective study comparing safety and efficacy of erythromycin estolate, clindamycin and placebo for 6 weeks in 539 pregnant women with genital mycoplasma infections; AST elevations occurred in 10% with erythromycin [44-130 U/L], vs 2.4% with clindamycin [42-44 U/L] and 1.8% with placebo [42-88 U/L]; lower rates subsequently with stearate [3.0%]).

Lloyd-Still JD, Sherman JO, Boggs J, Demers LM. Erythromycin estolate hepatotoxicity. Am J Dis Child 1978; 132: 320. PubMed Citation (7 year old boy developed fever and severe right upper quadrant pain within 24 hours of re-exposure to erythromycin estolate [bilirubin 4.8 mg/dL, AST 150 U/L, Alk P 90 U/L, bile acids >100 fold increased]).

Rodriguez Cuartero A, Rodriguez Cuartero F, Alonso Fernandez J, Castillo Higueras PL. [Acute hepatitis caused by erythromycin] Rev Esp Enferm Apar Dig 1978; 54: 533-6. Spanish. PubMed Citation (29 year old pregnant woman had onset of abdominal pain and nausea within days of starting erythromycin, followed by miscarriage at 10 days and jaundice at two weeks [bilirubin 7.2 mg/dL, ALT 214 U/L, Alk P not done]; resolving within 1 month).

Gafter U, Mandel EM, Weiss S, Djaldetti M. Erythromycin estolate-induced hepatitis. Ultrastructural study of liver. N Y State J Med 1979; 79: 87-9. PubMed Citation (28 year old woman developed abdominal pain, fever and jaundice after 2 weeks of erythromycin estolate [12% eosinophils, bilirubin 3.7 mg/dL, ALT 175 U/L, Alk P 2 times ULN], recurring within 1 day of rechallenge with one pill [bilirubin 2.8 mg/dL], biopsy showing mild changes of cholestasis by electron microscopy with dilated canaliculi).

Krowchuk D, Seashore JH. Complete biliary obstruction due to erythromycin estolate administration in an infant. Pediatrics 1979; 64: 956-8. PubMed Citation (6 week old infant developed jaundice and acholic stools starting 6 days after course of erythromycin estolate which resolved after passing of "green plug" in stool).

Pessayre D, Benhamou JP. Hepatotoxicity of erythromycin derivatives. Br Med J 1979; 1: 1357. PubMed Citation (Letter in response to review that suggested that only the estolate form of erythromycin causes liver injury: argues that this is not correct).

Viteri AL, Greene JF Jr, Dyck WP. Erythromycin ethylsuccinate-induced cholestasis. Gastroenterology 1979; 76(5 Pt 1): 1007-8. PubMed Citation (Initial report of liver toxicity of ethylsuccinate, 52 year old woman developed abdominal pain 1 day after starting erythomycin ethylsuccinate, followed by fever and jaundice [AST 54 U/L, Alk P 178 U/L, bilirubin 4.8 mg/dL, GGT 197 U/L] resolving 5 weeks later: history was later obtained of similar episode with previous exposure to erythromycin).

Zafrani ES, Ishak KG, Rudzki C. Cholestatic and hepatocellular injury associated with erythromycin esters: report of nine cases. Dig Dis Sci 1979; 24: 385-96. PubMed Citation (Review of histology of 9 cases of erythromycin liver injury from Armed Forces Institute of Pathology files; mostly cholestatic or mixed enzyme pattern, all self-limited, [bilirubin 2.1-12 mg/dL, ALT 128-560 U/L, Alk P 2-12 times ULN]; liver histology showed cholestasis and hepatocellular injury).

Sullivan D, Csuka ME, Blanchard B. Erythromycin ethylsuccinate hepatotoxicity. JAMA 1980; 243: 1074. PubMed Citation (45 year old woman developed cholecystitis-like clinical picture with fever and eosinophilia 9 days after starting erythromycin ethylsuccinate [ALT rising to 613 U/L, Alk P 190 U/L but no jaundice], resolving rapidly after stopping).

Bachman BA, Boyd WP Jr, Brady PG. Erythromycin ethylsuccinate-induced cholestasis. Am J Gastroenterol 1982; 77: 397-400. PubMed Citation (49 year old woman with recurrent episodes of right upper quadrant pain and cholestatic jaundice caused by intermittent use of erythromycin ethylsuccinate, reproduced within 1 day of deliberate rechallenge [bilirubin 2.2 mg/dL, ALT 243 U/L, Alk P 438 U/L]).

Cocchi P, Silenzi M, Salvi G, Calabri G, Tamburini M, Alvisi P. [Hepatotoxic syndrome caused by erythromycin ethyl succinate] Minerva Pediatr 1982; 34: 68-9. Italian. PubMed Citation

Funck-Brentano C, Danan G, Pessayre D, Benhamou JP. [Hepatitis due to erythromycin ethylsuccinate] Gastroenterol Clin Biol 1982; 6: 1044-5. French. PubMed Citation (48 year old man developed fatigue after 9 and jaundice after 11 days of oral erythromycin ethylsuccinate [bilirubin 12.9 mg/dL, ALT 360 U/L, Alk P 2.5 times ULN] and prolonged jaundice [2 months] with slow recovery [drug not stopped promptly]).

Keeffe EB, Reis TC, Berland JE. Hepatotoxicity to both erythromycin estolate and erythromycin ethylsuccinate. Dig Dis Sci 1982; 27: 701-4. PubMed Citation (Two cases of erythromycin estolate liver injury with rapid recurrence on exposure to ethylsuccinate 13-15 years later; cholecystitis-like syndrome with abdominal pain and fever [peak AST 63 and 500 U/L, Alk P 99 and 159 U/L).

Ponsot P, Theodore C, Larrey D, Breil P, Hugentobler JP, Paolaggi JA. [Acute hepatitis caused by erythromycin propionate] Gastroenterol Clin Biol 1982; 6: 594. French. PubMed Citation (Third reported case of hepatitis from erythromycin propionate; 58 year old man developed abdominal pain and fever within 8 hours of taking drug [bilirubin 2.7 mg/dL, ALT 55 U/L, Alk P 5.4 times ULN], resolving within 1 week of stopping).

Funck-Brentano C, Pessayre D, Benhamou JP. [Hepatitis caused by various derivatives of erythromycin] Gastroenterol Clin Biol 1983; 7: 362-9. French. PubMed Citation

Hosker JP, Jewell DP. Transient, selective factor X deficiency and acute liver failure following chest infection treated with erythromycin BP. Postgrad Med J 1983; 59: 514-5. PubMed Citation (57 year old man developed "acute liver failure" and coagulopathy arising after 6 days of therapy with oral erythromycin base [bilirubin 2.0 mg/dL, AST 61 U/L, Alk P 866 U/L, protime 19.6 seconds], with eventual recovery).

Inman WH, Rawson NS. Erythromycin estolate and jaundice. Br Med J (Clin Res Ed) 1983; 286: 1954-5. PubMed Citation (Survey of

5000 physicians using erythromycin in UK during 2 months of 1982, 3 reports of jaundice attributable to drug, all due to erythromycin stearate).

Paliard P, Stremsdoerfer N, Moindrot H. [Acute hepatitis caused by erythromycin esters (propionate and ethylsuccinate)] Gastroenterol Clin Biol 1983; 7: 100-1. French. PubMed Citation (54 year old man developed cholecystitis-like syndrome after 15 days of erythromycin propionate; 2 years later patient received erythromycin ethylsuccinate and developed fever and jaundice 7 days later [bilirubin 3.8 mg/dL, ALT 194 U/L, Alk P 148 U/L], resolving within 3 weeks; then had positive response to deliberate rechallenge with propionate with fever and ALT rising to 323 U/L in 24 hours).

Phillips KG. Hepatotoxicity of erythromycin ethylsuccinate in a child. Can Med Assoc J 1983; 129: 411-2. PubMed Citation (9 year old boy developed right upper quadrant pain after 7 days of erythromycin ethylsuccinate therapy [bilirubin 3.1 mg/dL, AST 258 U/L, Alk P 424 U/L], resolving within 15 days of stopping).

Diehl AM, Latham P, Boitnott JK, Mann J, Maddrey WC. Cholestatic hepatitis from erythromycin ethylsuccinate. Am J Med 1984; 76: 931-4 PubMed Citation (46 and 54 year old women developed acute cholestatic hepatitis from erythromycin ethylsuccinate with latency of 2 and 6 days [with previous exposures] and ALT 98-405 U/L, Alk P 206-234 U/L [normal

Copyright. Privacy. Accessibility U. S. National Library of Medicine. 8600 Rockville Pike, Bethesda, MD 20894 National Institutes of Health. U. S. Department of Health & Human Services Graphic Courtesy of The Scientific Consulting Group, Inc, Last updated: 2016-09-6 02:33:51 PM (EST)

Kids Birthday Parties In Appleton, Wi - Indoor Party, Apeton

Appleton

Monkey Joe’s Is Your Appleton Party Headquarters

Where’s the silliest, safest, bounciest place for a birthday party in Appleton? Monkey Joe’s! Kids 12 and younger will love diving into the action in our safe, parent-approved play area. They can bounce back and forth between the inflatable slides and bouncy obstacles in our play space and the games in our arcade. Our party packages are perfect for birthdays, team celebrations, family reunions, and group events both large and small. Packages can accomodate up to 24 kids, but if you need to plan for 25 or more, just give us a call to discuss our after hours private event options.

When you book a party at Monkey Joe’s you don’t need to worry about a thing. We provide the party room, the food and utensils, the setup, and the post-party cleanup. All you need to do is sit back, relax, and get your camera ready to capture those bright, beaming smiles!

*Birthday party groups are allowed to bring their own cake (excluding ice cream cakes). No other outside food or drinks are permitted.

Packages and Pricing

Each package includes

2 hours in a private party suite with a dedicated party host

Invitations for your guests

We do all the set-up and clean up!

Gift for the birthday child

Drink for each child

Dedicated Party Pro

Paper plates, cups, tablecloth, utensils

Don't forget to add Balloons, Birthday Hat, Token Packages, Goodie Bags, Cotton Candy, Ice Cream or a special Icee for the Birthday Child. All other outside food, drink, balloons and presents are not allowed in our common area.

Food

You are allowed to bring a birthday cake with a reserved party

No outside food or drinks permitted

Addition: order by the box - $15.99 for 16" slices

Packages

Jumping Jubilee

$299.00 Monday - Thursday

$329.00 Saturday - Sunday/Holidays

Gabictal, Gabictal

Neurontin is used for treating seizures associated with epilepsy. Neurontin is an anticonvulsant.

Use Neurontin as directed by your doctor.

Take Neurontin by mouth with or without food.

Do not take an antacid containing aluminum or magnesium within 2 hours before you take Neurontin.

If you are taking half of a scored tablet as your dose, take the other half of that tablet as your next dose. Throw away any half-tablets not used within several days of breaking a scored tablet.

Do not suddenly stop taking Neurontin. You may have an increased risk of side effects (eg, seizures). If you need to stop Neurontin or add a new medicine, your doctor will gradually lower your dose.

If you miss a dose of Neurontin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Neurontin.

Store Neurontin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Neurontin out of the reach of children and away from pets.

Active Ingredient: Gabapentin.

Do NOT use Neurontin if:

you are allergic to any ingredient in Neurontin.

Some medical conditions may interact with Neurontin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have kidney problems and are on dialysis

if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions.

Some medicines may interact with Neurontin. Tell your health care provider if you are taking any medicines, especially any of the following:

Morphine because it may increase the risk of Neurontin's side effects, including drowsiness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Neurontin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

Neurontin may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Neurontin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.

Patients who take Neurontin may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Neurontin closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

Diabetes patients - Neurontin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Neurontin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Neurontin.

Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Neurontin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Neurontin with caution in the elderly; they may be more sensitive to its effects.

Neurontin may cause emotional or behavioral side effects in children 3 to 12 years. If the following side effects occur, notify your doctor immediately: emotional "swings", hostile or aggressive behavior, problems concentrating, decreased performance at school, an increase in restlessness or hyperactivity.

Neurontin should be used with extreme caution in children younger 3 years; safety and effectiveness in these children have not been confirmed.

Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Neurontin while you are pregnant. Neurontin is found in breast milk. If you are or will be breast-feeding while you use Neurontin, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Neurontin suddenly, you may have withdrawal symptoms. These may include dizziness, drowsiness, clumsiness, hostility, hyperactivity, mood swings, nausea, tiredness, or vomiting.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Back pain; changes in vision (double or blurred vision); clumsiness; constipation; diarrhea; dizziness; drowsiness; dry mouth; nausea; stomach upset; tiredness; vomiting; weight gain.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; back and forth eye movements; behavioral problems; change in school performance; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hyperactivity; loss of coordination; memory loss; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); new or worsening seizures; numbness of an arm or leg; one-sided weakness; severe headache or dizziness; shortness of breath; speech changes; suicidal thoughts or actions; swelling of the hands, legs, or feet; tremor; trouble concentrating; twitching.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

Neurontin is used for treating seizures associated with epilepsy. Neurontin is an anticonvulsant.

Use Neurontin as directed by your doctor.

Take Neurontin by mouth with or without food.

Do not take an antacid containing aluminum or magnesium within 2 hours before you take Neurontin.

If you are taking half of a scored tablet as your dose, take the other half of that tablet as your next dose. Throw away any half-tablets not used within several days of breaking a scored tablet.

Do not suddenly stop taking Neurontin. You may have an increased risk of side effects (eg, seizures). If you need to stop Neurontin or add a new medicine, your doctor will gradually lower your dose.

If you miss a dose of Neurontin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Neurontin.

Store Neurontin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Neurontin out of the reach of children and away from pets.

Active Ingredient: Gabapentin.

Do NOT use Neurontin if:

you are allergic to any ingredient in Neurontin.

Some medical conditions may interact with Neurontin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have kidney problems and are on dialysis

if you have a history of mental or mood problems (eg, depression), or suicidal thoughts or actions.

Some medicines may interact with Neurontin. Tell your health care provider if you are taking any medicines, especially any of the following:

Morphine because it may increase the risk of Neurontin's side effects, including drowsiness.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Neurontin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

Neurontin may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Neurontin with caution. Do not drive or perform other possible unsafe tasks until you know how you react to it.

Patients who take Neurontin may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Neurontin closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

Diabetes patients - Neurontin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Neurontin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Neurontin.

Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Neurontin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Neurontin with caution in the elderly; they may be more sensitive to its effects.

Neurontin may cause emotional or behavioral side effects in children 3 to 12 years. If the following side effects occur, notify your doctor immediately: emotional "swings", hostile or aggressive behavior, problems concentrating, decreased performance at school, an increase in restlessness or hyperactivity.

Neurontin should be used with extreme caution in children younger 3 years; safety and effectiveness in these children have not been confirmed.

Pregnancy and breast-feeding: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Neurontin while you are pregnant. Neurontin is found in breast milk. If you are or will be breast-feeding while you use Neurontin, check with your doctor. Discuss any possible risks to your baby.

If you stop taking Neurontin suddenly, you may have withdrawal symptoms. These may include dizziness, drowsiness, clumsiness, hostility, hyperactivity, mood swings, nausea, tiredness, or vomiting.

All medicines may cause side effects, but many people have no, or minor, side effects.

Check with your doctor if any of these most common side effects persist or become bothersome:

Back pain; changes in vision (double or blurred vision); clumsiness; constipation; diarrhea; dizziness; drowsiness; dry mouth; nausea; stomach upset; tiredness; vomiting; weight gain.

Seek medical attention right away if any of these severe side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; back and forth eye movements; behavioral problems; change in school performance; chest pain; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hyperactivity; loss of coordination; memory loss; new or worsening mental or mood changes (eg, depression, agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, inability to sit still); new or worsening seizures; numbness of an arm or leg; one-sided weakness; severe headache or dizziness; shortness of breath; speech changes; suicidal thoughts or actions; swelling of the hands, legs, or feet; tremor; trouble concentrating; twitching.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.

Alfuzosin - Fda Prescribing Information, Side Effects And Uses, Alflosin

Alfuzosin

Testing for blood pressure changes or orthostatic hypotension was conducted in three controlled studies. Decreased systolic blood pressure (≤90 mm Hg, with a decrease ≥20 mm Hg from baseline) was observed in none of the 674 placebo patients and 1 (0.2%) of the 469 Alfuzosin hydrochloride patients. Decreased diastolic blood pressure (≤50 mm Hg, with a decrease ≥15 mm Hg from baseline) was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the Alfuzosin hydrochloride patients. A positive orthostatic test (decrease in systolic blood pressure of ≥20 mm Hg upon standing from the supine position) was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the Alfuzosin hydrochloride patients.

Post-marketing Experience

The following adverse reactions have been identified during post approval use of Alfuzosin hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General disorders: edema

Cardiac disorders: tachycardia, chest pain, angina pectoris in patients with pre-existing coronary artery disease, atrial fibrillation

Gastrointestinal disorders: diarrhea

Hepatobiliary disorders: hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation)

Respiratory system disorders: rhinitis

Reproductive system disorders: priapism

Skin and subcutaneous tissue disorders: rash, pruritis, urticaria, angioedema

Vascular disorders: flushing

Blood and lymphatic system disorders: thrombocytopenia

During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in some patients on or previously treated with alpha adrenergic antagonists [see Warnings and Precautions (5.6 )] .

Drug Interactions

CYP3A4 inhibitors

Alfuzosin hydrochloride is contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since Alfuzosin blood levels are increased [see Contraindications (4 ), Warnings and Precautions (5.4 ) and Clinical Pharmacology (12.3 )] .

Alpha adrenergic antagonists

The pharmacokinetic and pharmacodynamic interactions between Alfuzosin hydrochloride and other alpha adrenergic antagonists have not been determined. However, interactions may be expected, and Alfuzosin hydrochloride should not be used in combination with other alpha adrenergic antagonists [see Warnings and Precautions (5.4 )] .

Antihypertensive Medication and Nitrates

There may be an increased risk of hypotension/postural hypotension and syncope when taking Alfuzosin hydrochloride concomitantly with anti-hypertensive medication and nitrates [see Warnings and Precautions (5.1 )] .

PDE5 Inhibitors

Caution is advised when alpha adrenergic antagonists, including Alfuzosin hydrochloride, are coadministered with PDE 5 inhibitors. Alpha adrenergic antagonists and PDE 5 inhibitors are both vasodilators that can lower blood pressure.

Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see Warnings and Precautions (5.4 )] .

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category B. Alfuzosin hydrochloride is not indicated for use in women, and there are no studies of Alfuzosin in pregnant women.

Alfuzosin was not teratogenic, embryotoxic or fetotoxic in rats at plasma exposure levels (based on AUC of unbound drug) up to 1200 times (maternal oral dose of 250 mg/kg/day) the maximum recommended human dose (MRHD) of 10 mg. In rabbits administered up to 3 times the MRHD (based on body surface area) (maternal oral dose of 100 mg/kg/day) no embryofetal toxicity or teratogenicity was observed. Gestation was slightly prolonged in rats at exposure levels (based on AUC of unbound drug) approximately 12 times (greater than 5 mg/kg/day oral maternal dose) the MRHD, but difficulties with parturition were not observed.

Pediatric Use

Alfuzosin hydrochloride extended release tablets are not indicated for use in the pediatric population. Additional information regarding a clinical study in which efficacy was not demonstrated in pediatric patients ages 2 to 16 years is approved for Sanofi-Aventis U. S. LLC’s Alfuzosin hydrochloride extended-release tablets. However, due to Sanofi-Aventis U. S. LLC’s marketing exclusivity rights, this drug is not labeled with that pediatric information.

Geriatric Use

Of the total number of subjects in clinical studies of Alfuzosin hydrochloride, 48% were 65 years of age and over, whereas 11% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3 )] .

Renal impairment

Systemic exposure was increased by approximately 50% in pharmacokinetic studies of patients with mild, moderate, and severe renal impairment [see Clinical Pharmacology (12.3 )]. In phase 3 studies, the safety profile of patients with mild (n=172) or moderate (n=56) renal impairment was similar to the patients with normal renal function in those studies. Safety data are available in only a limited number of patients (n=6) with creatinine clearance below 30 mL/min; therefore, caution should be exercised when Alfuzosin hydrochloride is administered in patients with severe renal impairment [see Warnings and Precautions(5.2) ] .

Hepatic impairment

The pharmacokinetics of Alfuzosin hydrochloride have not been studied in patients with mild hepatic impairment. Alfuzosin hydrochloride is contraindicated for use in patients with moderate or severe hepatic impairment [see Contraindications ( 4 ), Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 )] .

Overdosage

Should overdose of Alfuzosin hydrochloride lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then the administration of intravenous fluids should be considered. If necessary, vasopressors should then be used, and the renal function should be monitored and supported as needed. Alfuzosin is 82% to 90% protein bound; therefore, dialysis may not be of benefit.

Alfuzosin Description

Each Alfuzosin hydrochloride extended-release tablet contains 10 mg Alfuzosin hydrochloride as the active ingredient. Alfuzosin hydrochloride is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane. Alfuzosin hydrochloride, USP is (R, S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The empirical formula of Alfuzosin hydrochloride is C 19 H 27 N 5 O 4 •HCl. The molecular weight of Alfuzosin hydrochloride is 425.9.

Its structural formula is:

The tablet also contains the following inactive ingredients: microcrystalline cellulose (NF), guar gum (NF), hydroxypropyl methyl cellulose (USP), colloidal silicon dioxide (NF) and magnesium stearate (NF).

Alfuzosin - Clinical Pharmacology

Mechanism of Action

Alfuzosin is a selective antagonist of post-synaptic alpha1-adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra.

Pharmacodynamics

Alfuzosin exhibits selectivity for alpha adrenergic receptors in the lower urinary tract. Blockade of these adrenoreceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow and a reduction in symptoms of BPH.

Cardiac Electrophysiology The effect of 10 mg and 40 mg Alfuzosin on QT interval was evaluated in a double-blind, randomized, placebo and active-controlled (moxifloxacin 400 mg), 4-way crossover single dose study in 45 healthy white male subjects aged 19 to 45 years. The QT interval was measured at the time of peak Alfuzosin plasma concentrations. The 40 mg dose of Alfuzosin was chosen because this dose achieves higher blood levels than those achieved with the co-administration of Alfuzosin hydrochloride and ketoconazole 400 mg. Table 3 summarizes the effect on uncorrected QT and mean corrected QT interval (QTc) with different methods of correction (Fridericia, population specific and subject-specific correction methods) at the time of peak Alfuzosin plasma concentrations. No single one of these correction methodologies is known to be more valid. The mean change of heart rate associated with a 10 mg dose of Alfuzosin in this study was 5.2 beats/minute and 5.8 beats/minute with 40 mg Alfuzosin. The change in heart rate with moxifloxacin was 2.8 beats/minute.

Table 3. Mean QT and QTc changes in msec (95% CI) from baseline at T max (relative to placebo) with different methodologies to correct for effect of heart rate.

The QT effect appeared greater for 40 mg compared to 10 mg Alfuzosin. The effect of the highest Alfuzosin dose (four times the therapeutic dose) studied did not appear as large as that of the active control moxifloxacin at its therapeutic dose. This study, however, was not designed to make direct statistical comparisons between the drugs or the dose levels. There has been no signal of Torsade de Pointes in the extensive post-marketing experience with Alfuzosin outside the United States.

A separate post-marketing QT study evaluated the effect of the co-administration of 10 mg Alfuzosin with a drug of similar QT effect size. In this study, the mean placebo-subtracted QTcF increase of Alfuzosin 10 mg alone was 1.9 msec (upperbound 95% Cl, 5.5 msec). The concomitant administration of the two drugs showed an increased QT effect when compared with either drug alone. This QTcF increase [5.9 msec (UB 95% Cl, 9.4 msec)] was not more than additive. Although this study was not designed to make direct statistical comparisons between drugs, the QT increase with both drugs given together appeared to be lower than the QTcF increase seen with the positive control moxifloxacin 400 mg [10.2 msec (UB 95% Cl, 13.8 msec)]. The clinical impact of these QTc changes is unknown.

Pharmacokinetics

The pharmacokinetics of Alfuzosin hydrochloride have been evaluated in adult healthy male volunteers after single and/or multiple administration with daily doses ranging from 7.5 mg to 30 mg, and in patients with BPH at doses from 7.5 mg to 15 mg.

Absorption The absolute bioavailability of Alfuzosin hydrochloride 10 mg tablets under fed conditions is 49%. Following multiple dosing of 10 mg Alfuzosin hydrochloride under fed conditions, the time to maximum concentration is 8 hours. C max and AUC 0-24 are 13.6 (SD = 5.6) ng/mL and 194 (SD = 75) ng•h/mL, respectively. Alfuzosin hydrochloride exhibits linear kinetics following single and multiple dosing up to 30 mg. Steady-state plasma levels are reached with the second dose of Alfuzosin hydrochloride administration. Steady-state Alfuzosin plasma concentrations are 1.2- to 1.6-fold higher than those observed after a single administration.

Effect of Food As illustrated in Figure 1, the extent of absorption is 50% lower under fasting conditions. Therefore, Alfuzosin hydrochloride should be taken with food and with the same meal each day [see Dosage and Administration (2 )] .

Figure 1 – Mean (SEM) Alfuzosin Plasma Concentration-Time Profiles after a Single Administration of Alfuzosin Hydrochloride 10 mg tablets to 8 Healthy Middle-Aged Male Volunteers in Fed and Fasted States

Distribution The volume of distribution following intravenous administration in healthy male middle-aged volunteers was 3.2 L/kg. Results of in vitro studies indicate that Alfuzosin is moderately bound to human plasma proteins (82% to 90%), with linear binding over a wide concentration range (5 to 5,000 ng/mL).

Metabolism Alfuzosin undergoes extensive metabolism by the liver, with only 11% of the administered dose excreted unchanged in the urine. Alfuzosin is metabolized by three metabolic pathways: oxidation, O-demethylation, and N-dealkylation. The metabolites are not pharmacologically active. CYP3A4 is the principal hepatic enzyme isoform involved in its metabolism.

Excretion Following oral administration of 14 C-labeled Alfuzosin solution, the recovery of radioactivity after 7 days (expressed as a percentage of the administered dose) was 69% in feces and 24% in urine. Following oral administration of Alfuzosin hydrochloride 10 mg tablets, the apparent elimination half-life is 10 hours.

Geriatric Use: In a pharmacokinetic assessment during phase 3 clinical studies in patients with BPH, there was no relationship between peak plasma concentrations of Alfuzosin and age.

However, trough levels were positively correlated with age. The concentrations in subjects ≥75 years of age were approximately 35% greater than in those below 65 years of age.

Renal Impairment: The Pharmacokinetic profiles of Alfuzosin hydrochloride 10 mg tablets in subjects with normal renal function (CLCR>80 mL/min), mild impairment (CLCR 60 to 80 mL/min), moderate impairment (CLCR 30 to 59 mL/min), and severe impairment (CLCR <30 mL/min) were compared. These clearances were calculated by the Cockcroft-Gault formula. Relative to subjects with normal renal function, the mean C max and AUC values were increased by approximately 50% in patients with mild, moderate, or severe renal impairment [see Warnings and Precautions (5.2 ) and Use in Specific Populations (8.6 )] .

Hepatic Impairment: The pharmacokinetics of Alfuzosin hydrochloride have not been studied in patients with mild hepatic impairment. In patients with moderate or severe hepatic insufficiency (Child-Pugh categories B and C), the plasma apparent clearance (CL/F) was reduced to approximately one-third to one-fourth that observed in healthy subjects. This reduction in clearance results in three to four-fold higher plasma concentrations of Alfuzosin in these patients compared to healthy subjects. Therefore, Alfuzosin hydrochloride is contraindicated in patients with moderate to severe hepatic impairment [see Contraindications (4 ), Warnings and Precautions (5.3 ) and Use in Specific Populations (8.7 )] .

Pediatric Use: Alfuzosin hydrochloride tablets are not indicated for use in the pediatric population [see Indications and Usage (1.1 ) and Use in Specific Populations (8.4 )] .

Metabolic Interactions CYP3A4 is the principal hepatic enzyme isoform involved in the metabolism of Alfuzosin.

Potent CYP3A4 Inhibitors Repeated oral administration of 400 mg/day of ketoconazole, a potent inhibitor of CYP3A4, increased Alfuzosin Cmax by 2.3-fold and AUClast by 3.2-fold, following a single 10 mg dose of Alfuzosin.

In another study, repeated oral administration of a lower (200 mg/day) dose of ketoconazole increased Alfuzosin Cmax by 2.1 - fold and AUClast by 2.5-fold, following a single 10 mg dose of Alfuzosin. Therefore, Alfuzosin hydrochloride is contraindicated for co-administration with potent inhibitors of CYP3A4 (e. g. ketoconazole, itraconazole, or ritonavir) because of increased Alfuzosin exposure[ see Contraindications (4 ), Warnings and Precautions (5.4 ) and Drug Interactions ( 7.1 )] .

Moderate CYP3A4 Inhibitors

Diltiazem: Repeated co-administration of 240 mg/day of diltiazem, a moderately-potent inhibitor of CYP3A4, with 7.5 mg/day (2.5 mg three times daily) Alfuzosin (equivalent to the exposure with Alfuzosin hydrochloride) increased the C max and AUC 0-24 of Alfuzosin 1.5- and 1.3-fold, respectively. Alfuzosin increased the C max and AUC 0-12 of diltiazem 1.4-fold. Although no changes in blood pressure were observed in this study, diltiazem is an antihypertensive medication and the combination of Alfuzosin hydrochloride and antihypertensive medications has the potential to cause hypotension in some patients [see Warnings and Precautions (5.1 )] .

In human liver microsomes, at concentrations that are achieved at the therapeutic dose, Alfuzosin did not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6 or 3A4 isoenzymes. In primary culture of human hepatocytes, Alfuzosin did not induce CYP1A, 2A6 or 3A4 isoenzymes.

Warfarin: Multiple dose administration of an immediate release tablet formulation of Alfuzosin 5 mg twice daily for six days to six healthy male volunteers did not affect the pharmacological response to a single 25 mg oral dose of warfarin.

Digoxin: Repeated co-administration of Alfuzosin hydrochloride 10 mg tablets and digoxin 0.25 mg/day for 7 days did not influence the steady-state pharmacokinetics of either drug.

Cimetidine: Repeated administration of 1 g/day cimetidine increased both Alfuzosin C max and AUC values by 20%.

Atenolol: Single administration of 100 mg atenolol with a single dose of 2.5 mg of an immediate release Alfuzosin tablet in eight healthy young male volunteers increased Alfuzosin C max and AUC values by 28% and 21%, respectively. Alfuzosin increased atenolol C max and AUC values by 26% and 14%, respectively. In this study, the combination of Alfuzosin with atenolol caused significant reductions in mean blood pressure and in mean heart rate. [see Warnings and Precautions (5.1 )] .

Hydrochlorothiazide: Single administration of 25 mg hydrochlorothiazide did not modify the pharmacokinetic parameters of Alfuzosin. There was no evidence of pharmacodynamic interaction between Alfuzosin and hydrochlorothiazide in the 8 patients in this study.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of a drug-related increase in the incidence of tumors in mice following dietary administration of 100 mg/kg/day Alfuzosin for 98 weeks (13 and 15 times the maximum recommended human dose [MRHD] of 10 mg based on AUC of unbound drug), in females and males, respectively. The highest dose tested in female mice may not have constituted a maximally tolerated dose. Likewise, there was no evidence of a drug-related increase in the incidence of tumors in rats following dietary administration of 100 mg/kg/day Alfuzosin for 104 weeks (53 and 37 times the MRHD in females and males, respectively).

Alfuzosin showed no evidence of mutagenic effect in the Ames and mouse lymphoma assays, and was free of any clastogenic effects in the Chinese hamster ovary cell and in vivo mouse micronucleus assays. Alfuzosin treatment did not induce DNA repair in a human cell line.

There was no evidence of reproductive organ toxicity when male rats were administered oral doses of several hundred times (250 mg/kg/day for 26 weeks) the MRHD of Alfuzosin. No impairment of fertility was observed following oral (gavage) administration to male rats at doses of up to 125 mg/kg/day for 70 days. Estrous cycling was inhibited in rats and dogs at approximately 12 and 18 times the MRHD respectively (doses of 25 mg/kg and 20 mg/kg, respectively), but did not result in impaired fertility in female rats.

Clinical Studies

Three randomized placebo-controlled, double-blind, parallel-arm, 12-week trials were conducted with the 10 mg daily dose of Alfuzosin. In these three trials, 1,608 patients [mean age 64.2 years, range 49-92 years; Caucasian (96.1%), Black (1.6%), Asian (1.1%), other (1.2%)] were randomized and 473 patients received Alfuzosin hydrochloride 10 mg daily. Table 4 provides the results of the three trials that evaluated the 10 mg dose.

There were two primary efficacy variables in these three studies. The International Prostate Symptom Score (IPSS, or AUA Symptom Score) consists of seven questions that assess the severity of both irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with possible scores ranging from 0 to 35 with higher numerical scores on the IPSS total symptom score representing greater severity of symptoms. The second efficacy variable was peak urinary flow rate. The peak flow rate was measured just prior to the next dose in study 2 and on average at 16 hours post dosing in trials 1 and 3.

There was a statistically significant reduction from baseline to last assessment (Week 12) in the IPSS total symptom score versus placebo in all three studies, indicating a reduction in symptom severity (Table 5 and Figures 2, 3, and 4).

Table 4 — Mean Change (SD) from Baseline to week 12 in International Prostate Symptom Score in Three Randomized, Controlled, Double Blind Trials

a Difference between baseline and week 12.

Figure 2 — Mean Change from Baseline in IPSS Total Symptom Score: Trial 1

Figure 3 — Mean Change from Baseline in IPSS Total Symptom Score: Trial 2

Figure 4 — Mean Change from Baseline in IPSS Total Symptom Score: Trial 3

Peak urinary flow rate was increased statistically significantly from baseline to last assessment (Week 12) versus placebo in trials 1 and 2 (Table 5 and Figures 5, 6, and 7).

Table 5 — Mean (SD) Change from Baseline to Week 12 in Peak Urine Flow Rate (mL/sec) in Three Randomized, Controlled, Double-Blind Trials

a Difference between baseline and week 12.

Figure 5 — Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 1

Figure 6 — Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 2

Figure 7 — Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 3

Mean total IPSS decreased at the first scheduled observation at Day 28 and mean peak flow rate increased starting at the first scheduled observation at Day 14 in trials 2 and 3 and Day 28 in trial 1.

How Supplied/Storage and Handling

Alfuzosin hydrochloride Extended-Release tablets are supplied as follows:

Alfuzosin hydrochloride extended-release tablets 10 mg are available as off white, round, biconvex tablets debossed with ‘IG’ on one side and “302” on other. Alfuzosin hydrochloride is supplied as follows:

90 TABLET in a BOTTLE (0440-5000-90)

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP.

Keep Alfuzosin hydrochloride out of reach of children.

PACKAGED BY: AIDAREX PHARMCEUTICALS LLC,

CORONA CA, 92880

REVISED ON: 08/2016

Patient Counseling Information

See FDA-approved patient labeling.

Hypotension/Syncope:

Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when beginning Alfuzosin hydrochloride, and they should be cautioned about driving, operating machinery, or performing hazardous tasks during this period. This is important for those with low blood pressure or who are taking antihypertensive medications or nitrates [see Warnings and Precautions (5.1 )].

Intraoperative Floppy Iris Syndrome:

Patients should be instructed to tell their ophthalmologist about their use of Alfuzosin hydrochloride before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking Alfuzosin hydrochloride [see Warnings and Precautions (5.6 )].

Priapism

Patients should be advised about the possibility of priapism resulting from treatment with Alfuzosin hydrochloride and medications in the same class. Although this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence) [see Warnings and Precautions (5.7 )].

Instructions of use

Alfuzosin hydrochloride should be taken with food and with the same meal each day. Patients should be advised not to crush or chew Alfuzosin hydrochloride tablets.

Alfuzosin hydrochloride extended-release tablets

Read the Patient Information that comes with Alfuzosin hydrochloride before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or your treatment. You and your doctor should talk about all your medicines, including Alfuzosin hydrochloride, now and at your regular checkups.

What is the most important information I should know about Alfuzosin hydrochloride?

Alfuzosin hydrochloride can cause serious side effects, including a sudden drop in blood pressure, especially when you start treatment. This may cause you to faint, or to feel dizzy or lightheaded.

Your risk of having this problem may be increased if you take Alfuzosin hydrochloride with certain other medicine that lowers blood pressure:

medicines for high blood pressure

a nitrate medicine for angina

Ask your doctor if you are not sure if you are taking one of these medicines.

Do not drive, operate machinery, or do any dangerous activities until you know how Alfuzosin hydrochloride affects you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure.

If you begin to feel dizzy or lightheaded, lie down with your legs and feet up. If your symptoms do not improve call your doctor.

See the section “What are the possible side effects of Alfuzosin hydrochloride?” for more information about side effects.

What is Alfuzosin hydrochloride.

Alfuzosin hydrochloride is a prescription medicine that is called an “alpha-blocker”.Alfuzosin hydrochloride is used in adult men to treat the symptoms of benign prostatic hyperplasia (BPH). Alfuzosin hydrochloride may help to relax the muscles in the prostate and the bladder which may lessen the symptoms of BPH and improve urine flow.

Before prescribing Alfuzosin hydrochloride, your doctor may examine your prostate gland and do a blood test called a prostate specific antigen (PSA) test to check for prostate cancer. Prostate cancer and BPH can cause the same symptoms. Prostate cancer needs a different treatment.

Alfuzosin hydrochloride is not for use in women or children.

Some medicines called “alpha-blockers” are used to treat high blood pressure.

Alfuzosin hydrochloride is not for the treatment of high blood pressure.

Who should not take Alfuzosin hydrochloride.

Do not take Alfuzosin hydrochloride if you:

have certain liver problems

take antifungal medicines like ketoconazole (Nizarol) or itraconazole (Sporanox)

take anti-HIV medicines like ritonavir (Norvir, Kaletra)

are allergic to Alfuzosin hydrochloride or any of the ingredients in Alfuzosin hydrochloride. See the end of this leaflet for a complete list of ingredients in Alfuzosin hydrochloride.

Before taking Alfuzosin hydrochloride, tell your doctor if you:

have liver problems

have kidney problems

have had low blood pressure, especially after taking another medicine. Signs of low blood pressure are fainting, dizziness, and lightheadedness.

have a heart problem called angina

or any family members have a rare heart condition known as congenital prolongation of the QT interval.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some of your other medicines may affect the way Alfuzosin hydrochloride works and cause serious side effects. See “What is the most important information I should know about Alfuzosin hydrochloride?”.

Especially tell your doctor if you take:

another alpha blocker medicine

a medicine to treat high blood pressure

a medicine to treat angina

a medicine to treat erectile dysfunction (ED)

the antifungal medicines like ketoconazole (Nizoral) or itraconazole (Sporanox)

the anti-HIV medicine like, ritonavir (Norvir, Kaletra)

Ask your doctor or pharmacist if you are not sure if your medicine is one of those listed above.

What you need to know while taking Alfuzosin hydrochloride tablets?

If you have an eye surgery for cataract (clouding of the eye) planned, tell your ophthalmologist that you are using Alfuzosin hydrochloride or have previously been treated with an alpha-blocker.

How do I take Alfuzosin hydrochloride tablets?

Take Alfuzosin hydrochloride tablets exactly as your doctor prescribes it.

Take Alfuzosin hydrochloride tablets after the same meal each day. Do not take it on an empty stomach.

Swallow the Alfuzosin hydrochloride tablet whole. Do not crush, split, or chew Alfuzosin hydrochloride extended-release tablets.

If you take too much Alfuzosin hydrochloride call your local poison control center or emergency room right away.

What are the possible side effects of Alfuzosin hydrochloride?

Alfuzosin hydrochloride can cause serious side effects, including:

See “What is the most important information I should know about Alfuzosin hydrochloride?”.

A painful erection that will not go away. Alfuzosin hydrochloride can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future.

The most common side effects with Alfuzosin hydrochloride are:

Call your doctor if you get any side effect that bothers you.

These are not all the side effects of Alfuzosin hydrochloride. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store Alfuzosin hydrochloride tablets?

Store Alfuzosin hydrochloride tablets at 20° to 25°C (68° to 77°F). [See USP].

Protect from light and moisture.

Keep Alfuzosin hydrochloride tablets and all medicines out of the reach of children.

General information about Alfuzosin hydrochloride.

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Alfuzosin hydrochloride for a condition for which it was not prescribed. Do not give Alfuzosin hydrochloride to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Alfuzosin hydrochloride. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Alfuzosin hydrochloride that is written for health professionals.

You may also visit our website at www. exelanpharma. com or call 1-855-295-7455.

What are the ingredients of Alfuzosin hydrochloride tablets?

Active ingredient: Alfuzosin hydrochloride, USP

Inactive ingredients: microcrystalline cellulose (NF), guar gum NF, hydroxypropyl methyl cellulose (USP), colloidal silicon dioxide (NF) and magnesium stearate (NF).

Manufactured for: Exelan Pharmaceuticals, Inc. Lawrenceville, GA 30046

Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Rev: 01/14

LABEL DISPLAY

Meneklin, Meneklin

Antibiotics - Meneklin (Brand name: cleocin)

Product Description Common use Cleocin kills sensitive bacteria by stopping the production of essential bacterial proteins after binding a bacterial ribosome. Cleocin is close by its qualities to Lincomycin. Lincosamides are usually used to treat staphylococci and streptococci. Cleocin is administered to treat protozoal diseases such as malaria, infections of respiratory system, skin and soft tissures, bones and joints, abdominal organs, and others. It does not treat meningitis.

Dosage and directions Take orally four times a day with or without food with a full glass of water. Take Cleocin at evenly spaced intervals.

Precautions This medication should be used only for treatment of serious bacterial infections due to its ability to cause severe and even fatal intestinal condition known as pseudomembranous colitis. This condition may appear during treatment or even weeks after treatment has stopped. So if you have persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool do not use anti-diarrhea drugs and inform your doctor about your condition.

Contraindications Do not take this drug if you have antibiotic-associated colitis, Crohn disease, ulcerative colitis or meningitis, have allergy to Cleocin or Lincomycides. Inform your doctor if you are pregnant or breastfeeding, if you have diarrhea, a history of liver problems or stomach or bowel problems before taking this medication.

Possible side effect Mild diarrhea, nausea, vomiting or upset stomach may occur. If they persist or become bothersome contact your doctor. Seek medical attention right away if you have serious signs of allergy (hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face) or other side effects: bloody or tarry stools, decreased urination, severe stomach cramps or pain, unusual vaginal discharge, yellowing of the skin or eyes.

Inform your doctor about all drugs you are taking and especially about erythromycin, kaolin-pectin, live bacterial vaccines. Clindamycin may increase the effects of drugs used during surgery so your doctor should know if you are taking Cleocin and plan to be operated.

Missed dose Never take a double dose of this medication. If it is almost time of the next dose just skip the missed portion and continue to take the medicine according to the schedule.

Overdose Cleocin overdose may cause serious consequences, so in case of persistent symptoms of abdominal pain, nausea, vomiting, and diarrhea contact your doctor.

Storage Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture, kids and pets.

Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Betaloc - Uses, Side Effects, Interactions, Betabloc

Betaloc

How does this medication work? What will it do for me?

Metoprolol belongs to the class of medications called beta-blockers. Metoprolol is used to treat high blood pressure and prevent the symptoms of certain types of angina (chest pain). It is also used to help reduce the risk of death right after a heart attack. It works by reducing the demands put on the heart.

Metoprolol is also taken by people who have had a heart attack to reduce the risk of having another one. Metoprolol is often used in combination with other high blood pressure medications such as diuretics (water pills) when the use of one medication by itself is not enough to control blood pressure.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each mL of aqueous injectable solution contains metoprolol 1 mg and sodium chloride 9 mg.

How should I use this medication?

The usual maintenance dose of metoprolol ranges from 100 mg daily to 200 mg daily . however the dose may be increased to 400 mg daily if necessary to obtain symptom control. Immediate-release tablets are taken in 2 divided doses while slow-release tablets are taken once a day.

The medication may be taken with or without food. Try to take the doses of metoprolol at the same time each day.

The doctor may increase the dose if the desired results have not been achieved within one week. Once the best dose has been found with the immediate-release tablets, the slow-release tablets may be substituted at an equal daily dose for convenience.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e. g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take metoprolol if you:

are allergic to metoprolol or any ingredients of the medication

are allergic to other beta blockers

are scheduled to have anesthesia with an agent that causes myocardial depression (e. g. ether)

have a condition known as right ventricular failure caused by excessive blood pressure in the lungs

have a condition known as "sick sinus syndrome"

have a slow heartbeat caused by heart rhythm problems

have asthma or other obstructive respiratory diseases (for the intravenous form of metoprolol only)

have cardiogenic shock

have overt heart failure

have serious heart block

have severe circulatory disorders

have had a heart attack accompanied by:

a heart rate less than 45 beats per minute

significant heart block

very low blood pressure

moderate to severe cardiac failure

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

abdominal pain or discomfort

changes in sexual desire or ability

constipation

diarrhea

dizziness or lightheadedness

drowsiness (slight)

dry mouth

headache

increased sensitivity to sunlight

increased sweating

tiredness or weakness

vivid dreams

weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

back or joint pain

breathing difficulty or wheezing

chest pain

cold hands and feet

confusion

hallucinations (hearing or seeing things that aren't there)

red, scaling, or crusted skin

signs of depression (e. g. poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

signs of heart problems (e. g. fast, irregular heartbeat or pulse, chest pain, difficulty breathing, tiredness with activity, swelling of feet, ankles, or lower legs)

signs of kidney problems (e. g. increased need to urinate, decreased urine production, skin itching, nausea, vomiting, rash)

signs of liver problems (e. g. nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

slow heartbeat (especially less than 40 beats per minute)

tingling sensation in the extremities

Stop taking the medication and seek immediate medical attention if any of the following occur:

fingers or toes cold to touch, painful or discoloured

symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Breathing conditions: Patients with asthma and certain other breathing problems should, in general, not take a beta-blocker such as metoprolol. If you have these types of conditions and your doctor prescribed metoprolol for you, it may be at a lower dose, and your doctor will monitor you regularly while you are taking this medication.

Diabetes: The signs of low blood sugar may not be as noticeable when taking metoprolol. This medication may make it more difficult for people with diabetes to control their blood sugar. If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor will monitor you while you are taking this medication and may need to adjust the doses of antidiabetes medications.

Dizziness or fainting: Dizziness or fainting are side effects of metoprolol and may occur after first starting this medication. Avoid driving and other potentially hazardous tasks until you have determined how this medication affects you.

Heart disease: Beta-blockers, such as metoprolol, can worsen existing heart failure. It is important to take metoprolol exactly as prescribed by your doctor to decrease the chance of this happening. If you have a history of heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hyperthyroidism (high level of thyroid hormones): If you have hyperthyroidism, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Stopping the medication suddenly could worsen this condition.

Liver function . Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Severe allergies: If you have allergies severe enough to cause anaphylaxis (a severe allergic reaction where swelling of the face, lips, and throat make it difficult to breathe), discuss with your doctor about what to do if you have an allergic reaction. Metoprolol may make it more difficult to treat severe allergic reactions with epinephrine.

Stopping the medication: People with heart disease who stop taking this medication abruptly may experience severe effects, such as chest pain, irregular heartbeat, or heart attack. If you have heart disease, do not stop taking this medication without checking with your doctor first. When this medication needs to be stopped, it should be done gradually under supervision of your doctor.

Surgery: If you are scheduled for surgery, inform all health care professionals involved in your care that you are taking metoprolol.

Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking metoprolol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Normal adult doses of metoprolol may cause a drop in blood pressure that is larger than anticipated. Lower doses may be necessary for seniors.

What other drugs could interact with this medication?

There may be an interaction between metoprolol and any of the following:

acetylcholine

alcohol

alpha-1 blockers (e. g. doxazosin, prazosin, tamsulosin)

amphetamines (e. g. dextroamphetamine)

anesthetic agents

angiotensin converting enzyme inhibitors (ACEIs; e. g. captopril, ramipril)

angiotensin II receptor blockers (ARBs; e. g. irbesartan, losartan)

antiarrhythmic medications (e. g. amiodorone, quinidine, propafenone)

antidiabetes medications (e. g. glyburide, metformin, insulin)

antifungals (e. g. terbinafine)

antihistamines (e. g. diphenhydramine)

antimalarials (e. g. hydroxychloroquine, quinine)

antipsychotics (e. g. chlorpromazine, thioridazine)

aripiprazole

barbiturates

beta-agonists (asthma medications; e. g. salbutamol, salmeterol, formoterol)

beta-blockers (e. g. atenolol, metoprolol, propranolol)

bupropion

calcium channel blockers (e. g. verapamil, diltiazem, nifedipine, amlodipine)

celecoxib

clonidine

darunavir

digoxin

diuretics (water pills; e. g. furosemide, hydrochlorothiazide)

donepezil

epinephrine

epoprostenol

ergot derivatives (e. g. bromocriptine, ergotamine, methylergonovine)

fentanyl

floctafenine

galantamine

ginger

ginseng

imatinib

insulin

isoniazid

lidocaine

methacholine

methyldopa

methylphenidate

midodrine

monoamine oxidase (MAO) inhibitors (e. g. tranylcypromine, phenelzine)

nonsteroidal anti-inflammatories (NSAIDs; e. g. ibuprofen, indomethacin, naproxen)

norepinephrine

peginterferon alfa-2b

pentoxifylline

phosphodiesterase-5 inhibitors (e. g. sildenafil, tadalafil)

pilocarpine

quinidine

rifampin

ritonavir

rituximab

rivastigmine

selective serotonin reuptake inhibitors (e. g. fluoxetine, paroxetine, sertraline)

theophylline

ticlopidine

yohimbine

If you are taking any medications containing this drug, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

stop taking one of the medications,

change one of the medications to another,

change how you are taking one or both of the medications, or

leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription) and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or illegal drugs can affect the action of many medications, you should let your prescriber know if you use them.

Vesanoid - Fda Prescribing Information, Side Effects And Uses, Vesanoid

Vesanoid

1. Experienced Physician and Institution

Patients with acute promyelocytic leukemia (APL) are at high risk in general and can have severe adverse reactions to Vesanoid (tretinoin). Vesanoid should therefore be administered only to patients with APL under the strict supervision of a physician who is experienced in the management of patients with acute leukemia and in a facility with laboratory and supportive services sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity, including respiratory compromise. Use of Vesanoid requires that the physician concludes that the possible benefit to the patient outweighs the following known adverse effects of the therapy.

2. Retinoic Acid-APL Syndrome

About 25% of patients with APL treated with Vesanoid have experienced a syndrome called the retinoic acid-APL (RA-APL) syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension. It has been observed with or without concomitant leukocytosis. Endotracheal intubation and mechanical ventilation have been required in some cases due to progressive hypoxemia, and several patients have expired with multi-organ failure. The syndrome generally occurs during the first month of treatment, with some cases reported following the first dose of Vesanoid.

The management of the syndrome has not been defined rigorously, but high-dose steroids given at the first suspicion of the RA-APL syndrome appear to reduce morbidity and mortality. At the first signs suggestive of the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), high-dose steroids (dexamethasone 10 mg intravenously administered every 12 hours for 3 days or until the resolution of symptoms) should be immediately initiated, irrespective of the leukocyte count. The majority of patients do not require termination of Vesanoid therapy during treatment of the RA-APL syndrome. However, in cases of moderate and severe RA-APL syndrome, temporary interruption of Vesanoid therapy should be considered.

3. Leukocytosis at Presentation and Rapidly Evolving Leukocytosis During Vesanoid Treatment

During Vesanoid treatment about 40% of patients will develop rapidly evolving leukocytosis. Patients who present with high WBC at diagnosis (>5×10 9 /L) have an increased risk of a further rapid increase in WBC counts. Rapidly evolving leukocytosis is associated with a higher risk of life-threatening complications.

If signs and symptoms of the RA-APL syndrome are present together with leukocytosis, treatment with high-dose steroids should be initiated immediately. Some investigators routinely add chemotherapy to Vesanoid treatment in the case of patients presenting with a WBC count of >5×10 9 /L or in the case of a rapid increase in WBC count for patients leukopenic at start of treatment, and have reported a lower incidence of the RA-APL syndrome. Consideration could be given to adding full-dose chemotherapy (including an anthracycline if not contraindicated) to the Vesanoid therapy on day 1 or 2 for patients presenting with a WBC count of >5×10 9 /L, or immediately, for patients presenting with a WBC count of <5×10 9 /L, if the WBC count reaches ≥6×10 9 /L by day 5, or ≥10×10 9 /L by day 10, or ≥15×10 9 /L by day 28.

4. Teratogenic Effects.

Pregnancy Category D – see WARNINGS

There is a high risk that a severely deformed infant will result if Vesanoid is administered during pregnancy. If, nonetheless, it is determined that Vesanoid represents the best available treatment for a pregnant woman or a woman of childbearing potential, it must be assured that the patient has received full information and warnings of the risk to the fetus if she were to be pregnant and of the risk of possible contraception failure and has been instructed in the need to use two reliable forms of contraception simultaneously during therapy and for 1 month following discontinuation of therapy, and has acknowledged her understanding of the need for using dual contraception, unless abstinence is the chosen method

Within 1 week prior to the institution of Vesanoid therapy, the patient should have blood or urine collected for a serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL. When possible, Vesanoid therapy should be delayed until a negative result from this test is obtained. When a delay is not possible, the patient should be placed on two reliable forms of contraception. Pregnancy testing and contraception counseling should be repeated monthly throughout the period of Vesanoid treatment.

Vesanoid Description

Vesanoid (tretinoin) is a retinoid that induces maturation of acute promyelocytic leukemia (APL) cells in culture. It is available in a 10 mg soft gelatin capsule for oral administration. Each capsule also contains beeswax, butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes, hydrogenated vegetable oils and soybean oil. The gelatin capsule shell contains glycerin, yellow iron oxide, red iron oxide, titanium dioxide, methylparaben and propylparaben.

Chemically, tretinoin is all - trans retinoic acid and is related to retinol (Vitamin A). It is a yellow to light orange crystalline powder with a molecular weight of 300.44.

The structural formula is as follows:

The median time to CR was between 40 and 50 days (range: 2 to 120 days). Most patients in these studies received cytotoxic chemotherapy during the remission phase. These results compare to the 30% to 50% CR rate and ≤6 month median survival reported for cytotoxic chemotherapy of APL in the treatment of relapse.

Ten of 15 pediatric cases achieved CR (8 of 10 males and 2 of 5 females). There were insufficient patients of black, Hispanic or Asian derivation to estimate relative response rates in these groups, but responses were seen in each category.

Responses were seen in 3 of 4 patients for whom cytogenetic analysis failed to detect the t(15;17) translocation typically seen in APL. The t(15;17) translocation results in the PML/RARα gene, which appears necessary for this disease. Molecular genetic studies were not conducted in these cases, but it is likely they represent cases with a masked translocation giving rise to PML/RARα. Responses to tretinoin have not been observed in cases in which PML/RARα fusion has been shown to be absent.

Indications and Usage for Vesanoid

Vesanoid (tretinoin) capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. Vesanoid is for the induction of remission only. The optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for APL after completion of induction therapy with Vesanoid.

Contraindications

Vesanoid is contraindicated in patients with a known hypersensitivity to Vesanoid, any of its components, or other retinoids. Vesanoid should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin capsule.

Warnings

Pregnancy Category D

Tretinoin has teratogenic and embryotoxic effects in mice, rats, hamsters, rabbits and pigtail monkeys, and may be expected to cause fetal harm when administered to a pregnant woman. Tretinoin causes fetal resorptions and a decrease in live fetuses in all animals studied. Gross external, soft tissue and skeletal alterations occurred at doses higher than 0.7 mg/kg/day in mice, 2 mg/kg/day in rats, 7 mg/kg/day in hamsters, and at a dose of 10 mg/kg/day, the only dose tested, in pigtail monkeys (about 1/20, 1/4, and 1/2 and 4 times the human dose, respectively, on a mg/m 2 basis).

There are no adequate and well-controlled studies in pregnant women. Although experience with humans administered Vesanoid is extremely limited, increased spontaneous abortions and major human fetal abnormalities related to the use of other retinoids have been documented in humans. Reported defects include abnormalities of the CNS, musculoskeletal system, external ear, eye, thymus and great vessels; and facial dysmorphia, cleft palate, and parathyroid hormone deficiency. Some of these abnormalities were fatal. Cases of IQ scores less than 85, with or without obvious CNS abnormalities, have also been reported. All fetuses exposed during pregnancy can be affected and at the present time there is no antepartum means of determining which fetuses are and are not affected.

Effective contraception must be used by all females during Vesanoid therapy and for 1 month following discontinuation of therapy. Contraception must be used even when there is a history of infertility or menopause, unless a hysterectomy has been performed. Whenever contraception is required, it is recommended that two reliable forms of contraception be used simultaneously, unless abstinence is the chosen method. If pregnancy does occur during treatment, the physician and patient should discuss the desirability of continuing or terminating the pregnancy.

Patients Without the t(15;17) Translocation

Initiation of therapy with Vesanoid may be based on the morphological diagnosis of acute promyelocytic leukemia. Confirmation of the diagnosis of APL should be sought by detection of the t(15;17) genetic marker by cytogenetic studies. If these are negative, PML/RARα fusion should be sought using molecular diagnostic techniques. The response rate of other AML subtypes to Vesanoid has not been demonstrated; therefore, patients who lack the genetic marker should be considered for alternative treatment.

Retinoic Acid-APL (RA-APL) Syndrome

In up to 25% of patients with APL treated with Vesanoid, a syndrome occurs which can be fatal (see boxed WARNINGS and ADVERSE REACTIONS ).

Leukocytosis at Presentation and Rapidly Evolving Leukocytosis During Vesanoid Treatment

Pseudotumor Cerebri

Retinoids, including Vesanoid, have been associated with pseudotumor cerebri (benign intracranial hypertension), especially in pediatric patients. The concomitant use of other agents known to cause pseudotumor cerebri/intracranial hypertension, such as tetracyclines, might increase the risk of this condition (see PRECAUTIONS: Drug Interactions ). Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be evaluated for pseudotumor cerebri, and, if present, appropriate care should be instituted in concert with neurological assessment.

Lipids

Up to 60% of patients experienced hypercholesterolemia and/or hypertriglyceridemia, which were reversible upon completion of treatment. The clinical consequences of temporary elevation of triglycerides and cholesterol are unknown, but venous thrombosis and myocardial infarction have been reported in patients who ordinarily are at low risk for such complications.

Elevated Liver Function Test Results

Elevated liver function test results occur in 50% to 60% of patients during treatment. Liver function test results should be carefully monitored during treatment and consideration be given to a temporary withdrawal of Vesanoid if test results reach >5 times the upper limit of normal values. However, the majority of these abnormalities resolve without interruption of Vesanoid or after completion of treatment.

Precautions

General

Vesanoid has potentially significant toxic side effects in APL patients. Patients undergoing therapy should be closely observed for signs of respiratory compromise and/or leukocytosis (see boxed WARNINGS ). Supportive care appropriate for APL patients, eg, prophylaxis for bleeding, prompt therapy for infection, should be maintained during therapy with Vesanoid.

There is a risk of thrombosis (both venous and arterial) which may involve any organ system, during the first month of treatment (see ADVERSE REACTIONS ). Therefore, caution should be exercised when treating patients with the combination of Vesanoid and anti-fibrinolytic agents, such as tranexamic acid, aminocaproic acid or aprotinin (see Drug Interactions ).

The ability to drive or operate machinery might be impaired in patients treated with Vesanoid, particularly if they are experiencing dizziness or severe headache.

Microdosed progesterone preparations ("minipill") may be an inadequate method of contraception during treatment with Vesanoid.

Laboratory Tests

The patient's hematologic profile, coagulation profile, liver function test results, and triglyceride and cholesterol levels should be monitored frequently.

Drug Interactions

Limited clinical data on potential drug interactions are available.

Drugs Metabolized By the Hepatic P450 System

As Vesanoid is metabolized by the hepatic P450 system, there is a potential for alteration of pharmacokinetics parameters in patients administered concomitant medications that are also inducers or inhibitors of this system. Medications that generally induce hepatic P450 enzymes include rifampicin, glucocorticoids, phenobarbital and pentobarbital. Medications that generally inhibit hepatic P450 enzymes include ketoconazole, cimetidine, erythromycin, verapamil, diltiazem and cyclosporine. To date there are no data to suggest that co-use with these medications increases or decreases either efficacy or toxicity of Vesanoid.

Agents Known to Cause Pseudotumor Cerebri/Intracranial Hypertension (Such as Tetracyclines)

Vesanoid may cause pseudotumor cerebri/intracranial hypertension. Concomitant administration of Vesanoid and agents known to cause pseudotumor cerebri/intracranial hypertension as well might increase the risk of this condition (see WARNINGS ).

As with other retinoids, Vesanoid must not be administered in combination with vitamin A because symptoms of hypervitaminosis A could be aggravated.

Anti-fibrinolytic Agents (Such as Tranexamic Acid, Aminocaproic Acid, or Aprotinin)

Cases of fatal thrombotic complications have been reported rarely in patients concomitantly treated with Vesanoid and anti-fibrinolytic agents. Therefore, caution should be exercised when administering Vesanoid concomitantly with these agents (see PRECAUTIONS: General ).

Effect of Food

No data on the effect of food on the absorption of Vesanoid are available. The absorption of retinoids as a class has been shown to be enhanced when taken together with food.

Carcinogenesis, Mutagenesis and Impairment Of Fertility

No long-term carcinogenicity studies with tretinoin have been conducted. In short-term carcinogenicity studies, tretinoin at a dose of 30 mg/kg/day (about 2 times the human dose on a mg/m 2 basis) was shown to increase the rate of diethylnitrosamine (DEN)-induced mouse liver adenomas and carcinomas. Tretinoin was negative when tested in the Ames and Chinese hamster V79 cell HGPRT assays for mutagenicity. A twofold increase in the sister chromatid exchange (SCE) has been demonstrated in human diploid fibroblasts, but other chromosome aberration assays, including an in vitro assay in human peripheral lymphocytes and an in vivo mouse micronucleus assay, did not show a clastogenic or aneuploidogenic effect. Adverse effects on fertility and reproductive performance were not observed in studies conducted in rats at doses up to 5 mg/kg/day (about 2/3 the human dose on a mg/m 2 basis). In a 6-week toxicology study in dogs, minimal to marked testicular degeneration, with increased numbers of immature spermatozoa, were observed at 10 mg/kg/day (about 4 times the equivalent human dose in mg/m 2 ).

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from Vesanoid in nursing infants, mothers should discontinue nursing prior to taking this drug.

Pediatric Use

There are limited clinical data on the pediatric use of Vesanoid. Of 15 pediatric patients (age range: 1 to 16 years) treated with Vesanoid, the incidence of complete remission was 67%. Safety and effectiveness in pediatric patients below the age of 1 year have not been established. Some pediatric patients experience severe headache and pseudotumor cerebri, requiring analgesic treatment and lumbar puncture for relief. Increased caution is recommended in the treatment of pediatric patients. Dose reduction may be considered for pediatric patients experiencing serious and/or intolerable toxicity; however, the efficacy and safety of Vesanoid at doses lower than 45 mg/m 2 /day have not been evaluated in the pediatric population.

Geriatric Use

Of the total number of subjects in clinical studies of Vesanoid, 21.4% were 60 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

Virtually all patients experience some drug-related toxicity, especially headache, fever, weakness, and fatigue. These adverse effects are seldom permanent or irreversible nor do they usually require interruption of therapy. Some of the adverse events are common in patients with APL, including hemorrhage, infections, gastrointestinal hemorrhage, disseminated intravascular coagulation, pneumonia, septicemia, and cerebral hemorrhage. The following describes the adverse events, regardless of drug relationship, that were observed in patients treated with Vesanoid.

Typical Retinoid Toxicity

The most frequently reported adverse events were similar to those described in patients taking high doses of vitamin A and included headache (86%), fever (83%), skin/mucous membrane dryness (77%), bone pain (77%), nausea/vomiting (57%), rash (54%), mucositis (26%), pruritus (20%), increased sweating (20%), visual disturbances (17%), ocular disorders (17%), alopecia (14%), skin changes (14%), changed visual acuity (6%), bone inflammation (3%), visual field defects (3%).

RA-APL Syndrome

APL patients treated with Vesanoid have experienced a potentially fatal syndrome characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and multi-organ failure. This syndrome has occasionally been accompanied by impaired myocardial contractility and episodic hypotension and has been observed with or without concomitant leukocytosis. Some patients have expired due to progressive hypoxemia and multi-organ failure. The syndrome generally occurs during the first month of treatment, with some cases reported following the first dose of Vesanoid. The management of the syndrome has not been defined rigorously, but high-dose steroids given at the first signs of the syndrome appear to reduce morbidity and mortality. Treatment with dexamethasone, 10 mg intravenously administered every 12 hours for 3 days or until resolution of symptoms, should be initiated without delay at the first suspicion of symptoms (one or more of the following: fever, dyspnea, weight gain, abnormal chest auscultatory findings or radiographic abnormalities). Sixty percent or more of patients treated with Vesanoid may require high-dose steroids because of these symptoms. The majority of patients do not require termination of Vesanoid therapy during treatment of the syndrome.

Body as a Whole

General disorders related to Vesanoid administration and/or associated with APL included malaise (66%), shivering (63%), hemorrhage (60%), infections (58%), peripheral edema (52%), pain (37%), chest discomfort (32%), edema (29%), disseminated intravascular coagulation (26%), weight increase (23%), injection site reactions (17%), anorexia (17%), weight decrease (17%), myalgia (14%), flank pain (9%), cellulitis (8%), face edema (6%), fluid imbalance (6%), pallor (6%), lymph disorders (6%), acidosis (3%), hypothermia (3%), ascites (3%).

Respiratory System Disorders

Respiratory system disorders were commonly reported in APL patients administered Vesanoid. The majority of these events are symptoms of the RA-APL syndrome (see boxed WARNINGS ). Respiratory system adverse events included upper respiratory tract disorders (63%), dyspnea (60%), respiratory insufficiency (26%), pleural effusion (20%), pneumonia (14%), rales (14%), expiratory wheezing (14%), lower respiratory tract disorders (9%), pulmonary infiltration (6%), bronchial asthma (3%), pulmonary edema (3%), larynx edema (3%), unspecified pulmonary disease (3%).

Ear Disorders

Ear disorders were consistently reported, with earache or feeling of fullness in the ears reported by 23% of the patients. Hearing loss and other unspecified auricular disorders were observed in 6% of patients, with infrequent (<1%) reports of irreversible hearing loss.

Gastrointestinal Disorders

GI disorders included GI hemorrhage (34%), abdominal pain (31%), other gastrointestinal disorders (26%), diarrhea (23%), constipation (17%), dyspepsia (14%), abdominal distention (11%), hepatosplenomegaly (9%), hepatitis (3%), ulcer (3%), unspecified liver disorder (3%).

Cardiovascular and Heart Rate and Rhythm Disorders

Arrhythmias (23%), flushing (23%), hypotension (14%), hypertension (11%), phlebitis (11%), cardiac failure (6%) and for 3% of patients: cardiac arrest, myocardial infarction, enlarged heart, heart murmur, ischemia, stroke, myocarditis, pericarditis, pulmonary hypertension, secondary cardiomyopathy.

Central and Peripheral Nervous System Disorders and Psychiatric

Dizziness (20%), paresthesias (17%), anxiety (17%), insomnia (14%), depression (14%), confusion (11%), cerebral hemorrhage (9%), intracranial hypertension (9%), agitation (9%), hallucination (6%) and for 3% of patients: abnormal gait, agnosia, aphasia, asterixis, cerebellar edema, cerebellar disorders, convulsions, coma, CNS depression, dysarthria, encephalopathy, facial paralysis, hemiplegia, hyporeflexia, hypotaxia, no light reflex, neurologic reaction, spinal cord disorder, tremor, leg weakness, unconsciousness, dementia, forgetfulness, somnolence, slow speech.

Urinary System Disorders

Renal insufficiency (11%), dysuria (9%), acute renal failure (3%), micturition frequency (3%), renal tubular necrosis (3%), enlarged prostate (3%).

Miscellaneous Adverse Events

Isolated cases of erythema nodosum, basophilia and hyperhistaminemia, Sweet's syndrome, organomegaly, hypercalcemia, pancreatitis and myositis have been reported.

Additional Adverse Reactions Reported With Vesanoid

Cases of thrombosis (both venous and arterial) involving various sites (eg, cerebrovascular accident, myocardial infarction, renal infarct) have been reported rarely (see PRECAUTIONS: General ).

Rare cases of thrombocytosis have been reported.

Miscellaneous Adverse Events

Rare cases of vasculitis, predominantly involving the skin, have been reported.

Overdosage

In case of overdose with Vesanoid, reversible signs of hypervitaminosis A (headache, nausea, vomiting, mucocutaneous symptoms) can appear. The maximal tolerated dose in patients with myelodysplastic syndrome or solid tumors was 195 mg/m 2 /day. The maximal tolerated dose in pediatric patients was lower at 60 mg/m 2 /day. Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia. These symptoms have quickly resolved without apparent residual effects.

There is no specific treatment in the case of an overdose; however, it is important that the patient be treated in a special hematological unit.

Vesanoid Dosage and Administration

The recommended dose is 45 mg/m 2 /day administered as two evenly divided doses until complete remission is documented. Therapy should be discontinued 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first.

If after initiation of treatment of Vesanoid the presence of the t(15;17) translocation is not confirmed by cytogenetics and/or by polymerase chain reaction studies and the patient has not responded to Vesanoid, alternative therapy appropriate for acute myelogenous leukemia should be considered.

Vesanoid is for the induction of remission only. Optimal consolidation or maintenance regimens have not been determined. All patients should, therefore, receive a standard consolidation and/or maintenance chemotherapy regimen for APL after induction therapy with Vesanoid, unless otherwise contraindicated.

How is Vesanoid Supplied

Vesanoid is supplied as 10 mg capsules, two-tone (lengthwise), orange-yellow and reddish-brown and imprinted Vesanoid 10 ROCHE. Supplied in high-density polyethylene, opaque bottles of 100 capsules with child-resistant closure (NDC 0004-0250-01).

Store at 15° to 30°C (59° to 86°F). Protect from light.

Roche Laboratories Inc.

340 Kingsland Street

Nutley, NJ 07110–1199

Copyright © 1998-2008 by Roche Laboratories Inc. All rights reserved.

PRINCIPAL DISPLAY PANEL - 10 mg Capsule Bottle Label

Avamys Nasal Spray, Avamys

AVAMYS® nasal spray

Consumer Medicine Information

What is in this leaflet?

Please read this leaflet carefully before you use Avamys.

This leaflet answers some common questions about Avamys. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the expected benefits of you taking Avamys against the risks this medicine could have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What is Avamys used for?

Avamys is used to treat symptoms of allergic rhinitis including stuffy, runny or itchy nose, sneezing, and watery, itchy or red eyes. The effects are usually felt within the first day, although some people will not feel the effects until several days after first taking it.

Avamys contains the medicine fluticasone furoate. This medicine belongs to a group of medicines known as corticosteroids, frequently called 'steroids'. They are not 'anabolic steroids' which are the steroids sometimes misused by athletes.

Avamys works to decrease inflammation caused by allergy (rhinitis).

Your doctor may have prescribed Avamys for another reason.

Avamys is not addictive.

Before you use Avamys

Do not use if:

You must not use Avamys if:

you have ever had an allergic reaction to fluticasone furoate or any of the ingredients listed toward the end of this leaflet. (See "Ingredients")

the expiry date (EXP) printed on the pack has passed.

the packaging is torn or shows signs of tampering.

Tell your doctor if:

You must tell your doctor if:

you are allergic to foods, dyes, preservatives or any other medicines.

you are taking an antiviral medicine called a protease inhibitor (e. g. ritonavir) or a type of medicine used to treat fungal infections (e. g. ketoconazole).

you have severe liver problems.

you are taking any other medicines, including medicines you buy without a prescription. This includes inhaled, oral or injected steroids.

you are breastfeeding, pregnant or trying to become pregnant.

How do I use Avamys?

How much to use

Take Avamys as directed by your doctor or pharmacist. Don't exceed the recommended dose.

Adults and adolescents 12 years and older:

The usual starting dose is 2 sprays in each nostril once a day.

Once symptoms are controlled you may be able to decrease your dose to 1 spray in each nostril once a day.

Children (2 to 11 years):

The usual starting dose is 1 spray in each nostril once a day.

If symptoms are severe your doctor may increase the dose to 2 sprays in each nostril once a day until symptoms are under control. It may then be possible for the dose to be reduced to 1 spray in each nostril once a day.

How to use it

See the instruction leaflet inside the pack for information on how to use Avamys.

Shake well before use.

Avamys is sprayed into the nose as a fine mist. It has virtually no taste.

Avamys is not for use in the eyes.

Use Avamys once a day and at the same time each day. This will treat your symptoms throughout the day and night.

How long to use it for

Your doctor will tell you how long to use Avamys.

Do not stop using Avamys, or change the dose without first checking with your doctor.

Use in children

Avamys is not recommended for use in children below 2 years of age.

What do I do if I use too much? (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, if you think you or anyone else may have taken too much Avamys, even if there are no signs of discomfort or poisoning.

If you are not sure what to do, contact your doctor or pharmacist.

While you are using Avamys

Things you must do

Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.

If you forget to use Avamys:

If you miss a dose, take it when you remember.

If it is almost time for your next dose, wait until then. Do not take a double dose to make up for a forgotten dose.

Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Things you must not do

Do not use Avamys in or near the eyes.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not use Avamys to treat any other complaints unless your doctor says to.

Things to be careful of

Be careful driving or operating machinery until you know how Avamys affects you. Avamys is unlikely to affect your ability to drive or use machinery.

What are the side effects?

Check with your doctor as soon as possible if you think you are experiencing any side effects or allergic reactions due to taking Avamys, even if the problem is not listed below.

Like other medicines, Avamys can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

The most commonly reported side effects are:

nose bleeds.

nasal ulceration - which may cause irritation or discomfort in your nose. You may also get streaks of blood when you blow your nose.

headache.

Uncommon side effects are:

Pain, burning, irritation, soreness or dryness in the inside of the nose.

Slowing of growth in children has also been observed, however the frequency of this occurring cannot be estimated from the available data.

Tell your doctor immediately if you notice any of the following:

These could be a symptom of an allergic reaction.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

How do I store Avamys?

Keep this medicine where children cannot reach it, such as in a locked cupboard.

Store Avamys below 30°C.

Do not refrigerate or freeze.

Always keep the cap on.

Do not leave in a car, on a window sill or in a bathroom.

Keep Avamys in its pack until it is time to use it.

Return any unused or expired medicine to your pharmacist.

Product description

What Avamys looks like

Avamys nasal spray is a white suspension contained in an amber glass bottle, fitted with a pump. The bottle is in an off-white plastic casing with a light blue cap and side-button. The casing has a window for viewing the bottle contents. The bottle contains either 30 or 120 sprays. Each spray delivers approximately 27.5 micrograms fluticasone furoate.

Ingredients

Avamys contains the active ingredient fluticasone furoate.

Avamys also contains glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water.

Supplier

Your Avamys is supplied by: GlaxoSmithKline Australia Pty Ltd Level 4, 436 Johnston Street, Abbotsford, Victoria, 3067 Australia

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

This leaflet was prepared on 10 August 2015.

The information provided applies only to: Avamys®

Avamys is a registered trade mark of the GlaxoSmithKline group of companies.

Avamys: AUST R 131443

© 2011-2015 GlaxoSmithKline

Published by MIMS November 2015

Consumers should be aware that the information provided by the Consumer Medicines Information (CMI) search (CMI Search) is for information purposes only and consumers should continue to obtain professional advice from a qualified healthcare professional regarding any condition for which they have searched for CMI. CMIs are provided by MIMS Australia. CMI is supplied by the relevant pharmaceutical company for each consumer medical product. All copyright and responsibility for CMI is that of the relevant pharmaceutical company. MIMS Australia uses its best endeavours to ensure that at the time of publishing, as indicated on the publishing date for each resource (e. g. Published by MIMS/myDr January 2007), the CMI provided was complete to the best of MIMS Australia's knowledge. The CMI and the CMI Search are not intended to be used by consumers to diagnose, treat, cure or prevent any disease or for any therapeutic purpose. Cirrus Media Pty Limited, its servants and agents shall not be responsible for the continued currency of the CMI, or for any errors, omissions or inaccuracies in the CMI and/or the CMI Search whether arising from negligence or otherwise or from any other consequence arising there from.

You may also like

Bula Do Medicamento Microdiol, Microdiol

Cada comprimido contem Desogestrel 0,15 mg; Etinilestradiol 0,03 mg.

Informacoes tecnicas - MICRODIOL

Caracteristicas: MICRODIOL e um anticoncepcional oral combinado que contem, como substancias ativas o estrogenio etinilestradiol e o progestagenio desogestrel. Os estudos clinicos revelaram que os anticoncepcionais orais contendo etinilestradiol e desogestrel nao provocam efeitos metabolicos considerados como de atividade androgenica, existentes em alguns outros progestagenicos utilizados em anticoncepcionais para uso oral. Quando administrado de acordo com o esquema posologico recomendado, MICRODIOL suprime a funcao gonadal hipofisaria, e consequentemente a ovulacao1. Alem disso, MICRODIOL induz um sangramento uterino regular com quantidade e duracao semelhantes a menstruacao2 normal. Este sangramento e indolor e normalmente inicia 2 ou 3 dias apos a ingestao do ultimo comprimido. Nos estudos clinicos, MICRODIOL demonstrou indice de gravidez3 bastante reduzido, bom controle do ciclo, baixa incidencia4 de efeitos colaterais, e como resultado, reduzido indice de descontinuidade.

Como anticoncepcional oral.

MICRODIOL e contra - indicado durante a gravidez3. Disturbios cardiovasculares ou cerebrovasculares, p. ex. tromboflebites5, processos tromboembolicos ou antecedentes dessas condicoes. Hipertensao6 grave. Disturbios hepaticos importantes ou antecedentes dessas condicoes, caso os resultados dos testes de funcao hepatica nao tenham retornado ao normal: ictericia7 colestatica, antecedentes de ictericia7 na gravidez3 ou durante o uso de esteroides. Sindromes de Rotor e de Dubin-Johnson. Presenca ou suspeita de tumores estrogenio-dependentes. Hiperplasia endometrial8. Sangramento vaginal sem diagnostico9. Porfiria10. Hiperlipoproteinemia, especialmente em presenca de outros fatores de risco que predisponham a doencas cardiovasculares11. Um historico de prurido12 intenso ou herpes gestacional durante a gravidez3, ou com uso previo de esteroides.

Advertencias e precaucoes - MICRODIOL

Os anticoncepcionais orais contendo estrogenio/progestagenio podem afetar a qualidade e reduzir a quantidade do leite materno. Uma pequena proporcao das substancias ativas pode ser excretada atraves do leite materno. Se ocorrerem quaisquer sinais13 de processos tromboembolicos, o tratamento devera ser interrompido imediatamente. O tabagismo aumenta o risco de doencas vasculares e esse risco e acentuado com a idade. Alem disso, esse risco e provavelmente um pouco maior nas usuarias de anticoncepcionais orais contendo estrogenios em relacao as nao - usuarias. Sendo assim, as mulheres com idades acima de 35 anos devem ser orientadas a parar de fumar, caso queiram utilizar esses produtos. Nas pacientes fazendo uso de medicamentos contendo estrogenios, o risco de trombose venosa profunda14 pode aumentar temporariamente, ao serem submetidas a cirurgia de grande porte ou imobilizacao prolongada. Na presenca de veias15 varicosas importantes, os beneficios dos medicamentos com estrogenios deverao ser avaliados contra os possiveis riscos. O tratamento devera ser interrompido, caso os resultados dos testes de funcao hepatica se tornem anormais. Muito raramente tem sido descritos adenomas de celulas hepaticas em usuarias de anticoncepcionais orais. O adenoma16 pode se apresentar como uma massa abdominal e(ou) com sinais13 e sintomas17 de dor abdominal aguda. Caso a paciente apresente dor abdominal ou sinais13 de sangramento intra-abdominal, deve-se considerar a presenca de adenoma16 celular hepatico hemorragico. Ocasionalmente verifica-se cloasma18 durante o uso de medicamentos contendo estrogenio e(ou) progestagenio, especialmente em mulheres com antecedentes de cloasma18 gravidico. As mulheres com tendencia a cloasma18 devem evitar exposicao ao sol durante o tratamento com estes medicamentos. Durante o uso de anticoncepcionais contendo estrogenios, podera, ocasionalmente, ocorrer depressao. Caso isso se acompanhe de disturbio no metabolismo19 de triptofano a administracao de vitamina20 B 6 podera ter valor terapeutico. O uso de esteroide pode influenciar os resultados de determinados testes laboratoriais. Recomenda-se exames medicos periodicos durante o tratamento prolongado com medicamentos contendo estrogenios e(ou) progestagenios. As pacientes portadoras de qualquer das seguintes condicoes deverao ser monitoradas: insuficiencia cardiaca21 latente ou manifesta, disfuncao renal22, hipertensao6, epilepsia23 ou enxaqueca24 (ou antecedentes dessas condicoes), pois pode ocorrer agravamento ou recorrencia dessas doencas ou eventualmente podem ser induzidas. Drepanocitose, pois sob certas circunstancias, como p. ex. durante infeccao25 ou anoxia, os medicamentos contendo estrogenios podem induzir processos tromboembolicos em pacientes com estas condicoes. Doencas ginecologicas sensiveis a acao estrogenica, como p. ex. fibromiomas uterinos, que podem aumentar de tamanho e endometriose26, que pode se agravar durante o tratamento com estrogenio.

Confiabilidade reduzida - MICRODIOL

Quando MICRODIOL e tomado de acordo com as instrucoes de uso, a ocorrencia de gravidez3 e altamente improvavel. No entanto, a confiabilidade dos anticoncepcionais orais pode ser reduzida quando: os comprimidos nao sao tomados de acordo com as instrucoes de uso, como p. ex. esquecimento da ingestao de um ou mais comprimidos. Ocorrer disturbios gastrintestinais com diarreia27 e(ou) vomito28 dentro de ate 4 horas apos a ingestao do comprimido. Administracao concomitante de outros medicamentos (ver Interacoes medicamentosas). Caso nao ocorra sangramento de privacao e nenhuma das circunstancias mencionadas acima estiver presente, a gravidez3 sera altamente improvavel, e o uso do anticoncepcional oral pode ser continuado. Se, no entanto, qualquer uma dessas eventualidades ocorrer, deve - se interromper a ingestao dos comprimidos e excluir-se a presenca de gravidez3 antes de retornar ao uso do anticoncepcional oral.

Interacoes medicamentosas - MICRODIOL

Sangramento irregular e confiabilidade reduzida poderao ocorrer quando os anticoncepcionais forem administrados concomitantemente com outros medicamentos, como os anticonvulsivantes, barbituricos, antibioticos (p. ex. tetraciclina, rifampicina, etc) e determinados laxantes29. Em diabeticas, os anticoncepcionais orais podem diminuir a tolerancia a glicose30 e aumentar as necessidades de insulina31 ou outros medicamentos antidiabeticos.

Efeitos colaterais e reacoes adversas - MICRODIOL

Foram associados ao tratamento com estrogenio e(ou) progestagenio as seguintes reacoes: Trato geniturinario: Sangramento intermenstrual, amenorreia32 pos - medicacao, alteracoes na secrecao cervical, aumento no tamanho dos fibromiomas uterinos, agravamento de endometriose26, certas infeccoes vaginais como a candidiase33. Mamas: Sensibilidade, dor, aumento e secrecao. Sistema gastrintestinal: Nausea34, vomito28, colelitiase35, ictericia7 colestatica. Sistema cardiovascular36: Tromboses, aumento da pressao arterial. Pele: Cloasma18, eritema37 nodoso, erupcao. Olhos: Desconforto da cornea quando em uso de lentes de contato. SNC: Cefaleia38, enxaqueca24, alteracoes do humor. Diversos: Retencao de liquidos, reducao da tolerancia a glicose30, alteracao do peso corporal.

Posologia e modo de usar - MICRODIOL

O primeiro comprimido da primeira cartela devera ser iniciado no primeiro dia da menstruacao2. Isso tambem e aplicavel quando houver troca de um outro anticoncepcional oral. Um comprimido e tomado diariamente no mesmo horario, sem interrupcao durante 21 dias, seguindo - se de uma pausa de 7 dias. Cada cartela seguinte sera iniciada apos o termino dessa pausa de 7 dias. A administracao de MICRODIOL podera ser iniciada a partir do 5o dia do ciclo, segundo criterio medico, porem medidas anticonceptivas adicionais deverao ser utilizadas durante os primeiros 14 dias do tratamento. A administracao apos o parto podera ser iniciada no 1o dia da 1a menstruacao2 espontanea. Caso seja necessario iniciar, antes, p. ex. imediatamente apos o parto, serao necessarias precaucoes anticoncepcionais adicionais durante os primeiros 14 dias de uso dos comprimidos. Apos aborto espontaneo ou provocado, a administracao devera ser iniciada imediatamente. Sendo assim, nao serao necessarias medidas anticoncepcionais adicionais.

A toxicidade tanto do desogestrel como do etinilestradiol e muito baixa. Sendo assim, nao se espera a ocorrencia de sintomas17 toxicos com MICRODIOL, quando, p. ex. uma crianca venha a ingerir diversos comprimidos simultaneamente. Os sintomas17 que podem ocorrer nesse caso, incluem: nausea34, vomito28 e, em meninas, leve sangramento vaginal. Provavelmente nao sera necessario tratamento especifico e, caso seja adequado, pode - se administrar tratamento de apoio, a criterio medico.

Embalagem com 21 comprimidos.

AKZO NOBEL Ltda. Divisao Organon.

Soloxine For Animal Use, Soloxine

Soloxine

This page contains information on Soloxine for veterinary use . The information provided typically includes the following:

Soloxine Indications

Warnings and cautions for Soloxine

Direction and dosage information for Soloxine

Soloxine

This treatment applies to the following species:

Dogs

(LEVOTHYROXINE SODIUM TABLETS, USP)

Soloxine Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Each SOLOXINE ® (Levothyroxine Sodium, USP) Tablet provides synthetic crystalline levothyroxine sodium (L-thyroxine).

The structural formula for levothyroxine sodium is:

Levothyroxine Sodium Action

Levothyroxine sodium acts, as does endogenous thyroxine, to stimulate metabolism, growth, development and differentiation of tissues. It increases the rate of energy exchange and increases the maturation rate of the epiphyses. Levothyroxine sodium is absorbed rapidly from the gastrointestinal tract after oral administration.

Following absorption, the compound becomes bound to the serum alpha globulin fraction. For purposes of comparison, 0.1 mg of levothyroxine sodium elicits a clinical response approximately equal to that produced by one grain (65 mg) of desiccated thyroid.

Soloxine Indications

Provides thyroid replacement therapy in all conditions of inadequate production of thyroid hormones. Hypothyroidism is the generalized metabolic disease resulting from deficiency of the thyroid hormones levothyroxine (T4) and liothyronine (T3). Soloxine (levothyroxine sodium) will provide levothyroxine (T4) as a substrate for the physiologic deiodination to liothyronine (T3). Administration of levothyroxine sodium alone will result in complete physiologic thyroid replacement.

Canine hypothyroidism is usually primary, i. e. due to atrophy of the thyroid gland. In the majority of cases the atrophy is associated with lymphocytic thyroiditis and in the remainder it is non-inflammatory and as of yet unknown etiology. Less than 10 percent of cases of hypothyroidism are secondary, i. e. due to deficiency of thyroid stimulating hormone (TSH). TSH deficiency may occur as a component of congenital hypopituitarism or as an acquired disorder in adult dogs, in which case it is invariably due to the growth of a pituitary tumor.

Hypothyroidism In The Dog

Hypothyroidism usually occurs in middle-aged and older dogs although the condition will sometimes be seen in younger dogs of the larger breeds. Neutered animals of either sex are also frequently affected, regardless of age. The following are clinical signs of hypothyroidism in dogs: Lethargy, lack of endurance, increased sleeping; Reduced interest, alertness and excitability; Slow heart rate, weak apex beat and pulse, low voltage on ECG; Preference for warmth, low body temperature, cool skin; Increased body weight; Stiff and slow movements, dragging of front feet; Head tilt, disturbed balance, unilateral facial paralysis; Atrophy of epidermis, thickening of dermis; Surface and follicular hyperkeratosis, pigmentation; Puffy face, blepharoptosis, tragic expression; Dry, coarse, sparse coat, slow regrowth after clipping; Retarded turnover of hair (carpet coat of boxers); Shortening or absence of estrus, lack of libido; Dry feces, occasional diarrhea; Hypercholesterolemia; Normochromic, normocytic anemia; Elevated serum creatinine phosphokinase

Contraindications

Levothyroxine sodium therapy is contraindicated in thyrotoxicosis, acute myocardial infarction and uncorrected adrenal insufficiency. Use in pregnant bitches has not been evaluated.

Precautions

The effects of levothyroxine sodium therapy are slow in being manifested. Overdosage of any thyroid drug may produce the signs and symptoms of thyrotoxicosis including, but not limited to: polydipsia, polyuria, polyphagia, reduced heat tolerance and hyperactivity or personality change. Administer with caution to animals with clinically significant heart disease, hypertension or other complications for which a sharply increased metabolic rate might prove hazardous.

Use in pregnant bitches has not been evaluated.

Adverse Reactions

There are no particular adverse reactions associated with levothyroxine sodium therapy at the recommended dosage levels. Overdosage will result in the signs of thyrotoxicosis listed above under precautions.

Dosage

The initial recommended dose is 0.1 mg/10 lb (4.5 kg) body weight twice daily. Dosage is then adjusted by monitoring the thyroid blood levels of the dog every four weeks until an adequate maintenance dose is established. The usual maintenance dose is 0.1 mg/10 lb. (4.5 kg) once daily.

DO NOT DISPENSE IN THIS CONTAINER, DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINERS AS DEFINED IN THE USP.

Administration

Soloxine tablets may be administered orally or placed in the food.

Dosage Forms Available

0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 and 1.0 mg tablets in bottles of 250 and 1,000.

Storage

Store at controlled room temperature 15°C to 30°C (59°F to 86°F).

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.

References

1. Evinger, J. V. and Nelson, R. W. JAVMA 314. 1984, 185, 314-316.

2. Richard Nelson, DVM; Current Veterinary Therapy X. Edited by R. W. Kirk, W. B. Saunders, Co. Philadelphia, PA 1989 pg:994

3. Edward Feldman, DVM and Richard Nelson, DVM Canine and Feline Endocrinology and Reproduction. W. B. Saunders 1987 pg 82

Virbac AH, Inc. Fort Worth, TX 76137

For More Information Call 1-800-338-3659

Danazol Oral Uses, Side Effects, Interactions, Pictures, Warnings - Dosing, Danol

danazol

GENERIC NAME(S): DANAZOL

Warnings

This medication must not be used during pregnancy. It may harm an unborn baby. In women of childbearing age, this medication should be started during their menstrual period. If not, then they should have a negative pregnancy test before starting this medication. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss the use reliable forms of non-hormonal birth control (such as condoms. diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

Danazol has rarely caused very serious (possibly fatal) blood clots (such as stroke ), liver disease, and increased pressure on the brain (benign intracranial hypertension ). Seek immediate medical attention if you have any symptoms of these side effects, including weakness on one side of the body, slurred speech, vision changes, severe stomach /abdominal pain. dark urine, persistent nausea /vomiting. yellowing eyes /skin. mental/mood changes (such as confusion), severe/persistent headache .

Uses

This medication is used in women to treat pelvic pain and infertility due to a certain uterus disorder (endometriosis ) and also to treat breast pain /tenderness/nodules due to a certain breast condition (fibrocystic breast disease). It is also used in both men and women to prevent swelling of the abdomen /arms/legs/face/airway due to a certain congenital disease (hereditary angioedema ).

Danazol is an androgen similar to testosterone. For the treatment of endometriosis and fibrocystic breast disease, it works by decreasing the amount of hormones made by the ovaries. These hormones usually make the conditions worse. For the treatment of angioedema, danazol helps to increase the amount of a certain protein in your body's defense system (immune system).

How to use danazol

Take this medication by mouth. usually twice daily or as directed by your doctor. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

See also Warning section.

Weight gain, acne. flushing, sweating. voice changes (hoarseness, change in pitch), abnormal growth of body hair (in women), vaginal dryness /irritation, or decreased breast size may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: swelling hands/ankles /feet, menstrual changes (such as spotting, missed periods), mental/mood changes (such as nervousness, mood swings).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction. including: rash. itching /swelling (especially of the face/tongue /throat), severe dizziness. trouble breathing .

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www. fda. gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking danazol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel disease (such as coronary artery disease. stroke), high blood pressure (hypertension), diabetes, high cholesterol levels. breast cancer, liver disease, kidney disease, seizures, migraine headaches. unusual vaginal bleeding, certain blood disorders (porphyria, polycythemia), prostate cancer.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may affect the sperm. Consult your doctor for more details.

This medication must not be used during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. (See also Warning section.)

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), carbamazepine, certain "statin" cholesterol medications (lovastatin, simvastatin).

This medication may interfere with certain laboratory tests (including blood levels of male hormones such as testosterone), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: yellowing eyes/skin, severe stomach/abdominal pain, dark urine.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as liver function, cholesterol levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised April 2016. Copyright(c) 2016 First Databank, Inc.

Images

The Quest Box™ A Geo Puzzle For Romantics And Adventurers, Sonidal

Find your adventure

A carefully crafted Quest delivers an unforgettable life experience: a journey of discovery limited only by imagination. How does it all work?

Romance and Adventure

When hopeful suitors hide engagement rings in Quest Boxes, wedding bells usually ring out. We’re a perfect 100% so far, and some say it’s the most romantic gift ever.

Community

You’re invited to join a growing community of Sundial Quest Box™ enthusiasts: real people sharing memorable experiences with friends, family, lovers, and you.

Questions and Answers

How close do you have to get before the box opens? What happens when you take a Quest Box through airport security? Find the answer to these and other common questions here.

Latest Diary Entries

Alomaron - Significado, Silabas, Sinonimos, Antonimos Y Rimas, Alomaron

alomaron

1. tr. Agr. Arar la tierra dejando entre surco y surco espacio mayor que de ordinario y de manera que quede formando lomos.

2. tr. Equit. Repartir la fuerza que el caballo suele tener en los brazos con mas exceso que en los lomos, lo cual se consigue con las ayudas y buena ensenanza.

3. prnl. Dicho de un caballo: Fortalecerse y nutrirse, quedando apto para padrear.

4. prnl. Dicho de un caballo: Encogerse o sentirse de los lomos.

Informacion sobre alomaron

Es un verbo .

Idiomas en los que se utiliza alomaron .

(pulsa el boton para escuchar su pronunciacion)

Separacion en silabas de alomaron

a - lo - ma - ron

Esta formada por 4 silabas y 8 letras.

alomaron es una palabra llana o grave . ya que su silaba tonica recae sobre la penultima silaba.

alomaron es una palabra polisilaba . ya que tiene cuatro o mas silabas.

Palabras que riman con alomaron

Atencion! Por rendimiento, solo se muestran las primeras 250 rimas de alomaron . Si necesitas buscar mas palabras que rimen con alomaron . prueba a realizar una busqueda mediante nuestro buscador de rimas .

Palabras que riman con alomaron de 2 silabas

Palabras que riman con alomaron de 3 silabas

Palabras que riman con alomaron de 4 silabas

Palabras que riman con alomaron de 5 silabas

Palabras que riman con alomaron de 6 silabas

Anacin - Pain Relief, Tandamol

Anacin is a pain reliever intended for the temporary relief of minor aches and pains. Anacin is a combination salicylate and stimulant. It works by blocking several different chemical processes within the body that cause pain, inflammation, and fever. It also reduces the tendency for blood to clot.

Availability: In Stock (17 packs)

Other names of Anacin:

Anacin is used for treating pain including, headache, muscle aches, sprains, tooth extraction and toothache, menstrual cramps, arthritis and rheumatism, and pain and fever of the common cold. It may also be used for other conditions as determined by your doctor.

Use Anacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Anacin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not decrease the risk of stomach or bowel problems (eg, bleeding, ulcers) that may occur while taking Anacin.

Take Anacin with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Anacin.

Use Anacin exactly as directed on the package, unless instructed differently by your doctor. If you are taking Anacin without a prescription, follow any warnings and precautions on the label.

If you miss a dose of Anacin and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Anacin.

Store Anacin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Anacin out of the reach of children and away from pets.

Anacin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Anacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate). This includes any medicines that contain caffeine.

Anacin has aspirin in it. Before you start any new medicine, check the label to see if it has aspirin in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Talk to your doctor before you take Anacin or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day. Serious stomach ulcers or bleeding can occur with the use of Anacin. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Anacin with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Taking more than the recommended dose or taking Anacin regularly may be habit-forming.

Anacin may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

Aspirin has been linked to a serious illness called Reye syndrome. Do not give Anacin to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.

Diabetes patients - Anacin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

If Anacin has a strong vinegar-like smell upon opening, do not use. It means the medicine is breaking down. Throw the bottle away safely and out of the reach of children; contact your pharmacist and replace.

Tell your doctor or dentist that you take Anacin before you receive any medical or dental care, emergency care, or surgery.

Do not take Anacin for at least 7 days after any surgery unless directed by your health care provider.

Do not take Anacin for more than 10 days for pain or for more than 3 days for fever unless directed to do so by your health care provider.

Different brands of Anacin may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.

Do NOT use Anacin if:

you are allergic to any ingredient in Anacin

you are a child or teenager with influenza (flu) or chickenpox

you have bleeding problems such as hemophilia, von Willebrand disease, or low blood platelets, or you have active severe bleeding

you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

you are taking anticoagulants (eg, heparin, warfarin) or methotrexate

Before using Anacin:

Some medical conditions may interact with Anacin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day

if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, stomach or intestinal problems (eg, ulcer, inflammation), heart problems, heartburn, upset stomach, stomach pain, hives, influenza (flu) or chickenpox, or vitamin K deficiency

if you have anxiety, trouble sleeping, or heart problems

if you are a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, rheumatic disease (eg, rheumatoid arthritis), or Kawasaki syndrome (a rare inflammation causing heart problems in children)

Some MEDICINES MAY INTERACT with Anacin. Tell your health care provider if you are taking any other medicines.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Anacin while you are pregnant. Anacin is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Anacin is found in breast milk. If you are or will be breast-feeding while you use Anacin, check with your doctor. Discuss any possible risks to your baby.

All medicines may cause side effects, but many people have no, or minor, side effects. Anacin's side effects may include dizziness, heartburn, irritability, nausea, nervousness, rashes, hives, bloody stools, drowsiness, hearing loss, ringing in the ears, and trouble sleeping.

Check with your doctor if any of the listed above most COMMON side effects persist or become bothersome.

Seek medical attention right away if any of these SEVERE side effects occur: severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; drowsiness; hearing loss; ringing in the ears; severe or persistent dizziness; severe or persistent stomach pain or heartburn; shakiness; trouble sleeping; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

Plant Profile For Salvia Nemorosa - Caradonna - Perennial Sage Perennial, Coradona

Salvia nemorosa ‘Caradonna’

Salvia nemorosa ‘Caradonna’

Plant number: 1.468.400

The Perennial Sages are invaluable perennials for their rich display of spiky flowers in the early summer border. This selection is medium to tall, with flowers of deep violet-blue held on unusually dark stems. Remove faded blooms to encourage repeat flowering. Excellent for cutting. Drought tolerant once established. Also tolerates heat and humidity. Plants may be easily divided in early spring or fall. Can be clipped back hard after blooming, to rejuvenate the foliage. Attractive to both butterflies and hummingbirds. Winner of the 2000 Outstanding New Perennial Award by the International Hardy Plant Union.

Further details for Salvia nemorosa ‘Caradonna’

Optimal Growing Conditions

Appearance and Characteristics

Soil pH Neutral or Alkaline or Acid

Soil Moisture Average or Dry or Moist

Blooming Time Early Summer Mid Summer

Foliage Color Grey Green

Plant Uses & Characteristics Accent: Good Texture/Form Attracts Butterflies Attracts Hummingbirds Border Containers Cut Flower Deer Resistant Drought Tolerant Rabbit Resistant Massed

Lamisil - Anti Fungal, Piecidex

Anti Fungal - Piecidex (Brand name: lamisil)

Product Description Common use Lamisil is an anti-fungal antibiotic used to treat tinea versicolor, a fungal infection that produces brown, tan, white spots on the trunk of the body or other fungal infections such as athlete's foot, jock itch, and ringworm. Lamisil works by killing sensitive fungi by interfering with the formation of the fungal cell membrane.

Dosage and direction Take it orally with full glass of water. Swallow it without chewing. Usually it taken for 6 to 12 weeks. The recommended dose is different from type of infection: 1. For onychomycosis: Adults and teenagers 250 mg once a day for 6 to 12 weeks. Lamisil is used in children just after doctor's permission. 2. For tinea corporis: Adults and teenagers 250 mg once a day for 2 to 4 weeks. Lamisil is used in children just after doctor's permission. 3. For tinea cruris (ringworm of the groin; jock itch): Adults and teenagers 250 mg once a day for 2 to 4 weeks. Lamisil is used in children just after doctor's permission. 4. For tinea pedis: Adults and teenagers 250 mg once a day for 2 to 6 weeks. Lamisil is used in children just after doctor's permission. Note: this instruction presented here just for review. It's very necessary to consult your doctor before using.

Precautions Before using this medicine, consult your doctor or pharmacist if you have a certain blood disorder or severe liver disease. Don't forget to tell your medical history, especially if it includes lupus. Driving is not recommended while you are taking this medication because it may cause dizziness or less alertness. Drinking alcohol during treatment may cause a fast heartbeat and flushing of the skin. Avoid sun, tanning booths, and sunlamps and use a sunscreen and wear protective clothing when going outdoors. Lamisil should not be used during pregnancy, becoming pregnant or lactating without doctor's advice. Do not use before breast-feeding without doctor's advice.

Contraindications Lamisil is not allowed to people who have problems with their liver or kidneys, hypersensitive to any component of this dug.

Possible side effect They may include an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Also the most possible side effects include: joint pain or swelling, swollen glands, patchy skin color, or a butterfly-shaped skin rash over your cheeks and nose fever, chills, body aches, flu symptoms; changes in your vision; weight loss due to taste changes; scaly, itchy, and flaky skin rash; fever, sore throat, and headache with a severe blistering, peeling, and red skin rash. Less serious include: stomach pain, heartburn, diarrhea; headache; tired feeling; runny or stuffy nose, sore throat, cold symptoms; mild skin rash or itching; unusual or unpleasant taste in your mouth; or decreased taste sensation. If you experience one of them stop using Lamisil and tell your doctor as soon as possible. Also consult your doctor about any side effect that seems unusual.

Drug interaction Lamisil interacts with the following medications: Cyclosporine Metoprolol Nortriptyline Warfarin Also note that interaction between two medications does not always mean that you must stop taking one of them. As usual it affects the effect of drugs, so consult your doctor about its interactions.

Missed dose If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not take double or extra doses. Take your usual dose next day at the same time regularly.

Overdose Symptoms of Lamisil overdose may include: dizziness, stomach pain, nausea, vomiting, skin rash, or urinating more than usual. If you experience one of them call your doctor immediately.

Storage Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture, kids and pets. Do not use after expiration date.

Disclaimer We provide only general information about medications that does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Albert Reid, Zach Dancel Transferring From Maryland Football - The Washington Post, Dancel

Albert Reid, Zach Dancel transferring from Maryland football

Maryland senior safety Zach Dancel and senior running back Albert Reid will transfer out of the football program. the school announced on Friday afternoon.

Dancel and Reid were granted their release by Maryland, and both players are expected to be immediately eligible to play as graduate transfers next year. Dancel is set to graduate from Maryland in May, while Reid will graduate later this summer.

Both struggled to climb the depth chart during Maryland’s spring practices, which wrapped up last weekend. Dancel took mostly second-team reps at safety throughout the spring, while Reid competed in a crowded backfield that included senior Brandon Ross and sophomore Jacquille Veii. Junior running back Wes Brown, a leading contender to start next season, is expected to return to the fold in August after missing spring practice while recovering from a torn labrum.

Dancel, who starred at Good Counsel and played his freshman season at New Mexico, played in 10 games last year and made one start a year after primarily serving as a special teams contributor. He registered 15 tackles last year, including one for loss.

A former Friendship Collegiate standout, Reid sat out most of last season with a knee injury and was one of eight Maryland players who received a medical hardship waiver earlier this month. Establishing himself as a hard-nosed runner with a reputable work ethic, Reid’s most productive season came in 2013, when he rushed 70 times for 294 yards and two touchdowns.

Get the top Olympics news by email

Major news and analysis from Rio, delivered to your inbox as it happens.

Please provide a valid email address.

Follow Team USA through the Olympics

The top news as Americans compete, delivered to your inbox as it happens.

Please provide a valid email address.

Roman Stubbs covers the University of Maryland athletics for The Washington Post.

SuperFan badge holders consistently post smart, timely comments about Washington area sports and teams.

Culture Connoisseur Badge

Culture Connoisseurs consistently offer thought-provoking, timely comments on the arts, lifestyle and entertainment.

Fact Checker Badge

Fact Checkers contribute questions, information and facts to The Fact Checker .

Washingtologists consistently post thought-provoking, timely comments on events, communities, and trends in the Washington area.

Post Writer Badge

This commenter is a Washington Post editor, reporter or producer.

Post Forum Badge

Post Forum members consistently offer thought-provoking, timely comments on politics, national and international affairs.

Weather Watcher Badge

Weather Watchers consistently offer thought-provoking, timely comments on climates and forecasts.

World Watcher Badge

World Watchers consistently offer thought-provoking, timely comments on international affairs.

Post Contributor Badge

This commenter is a Washington Post contributor. Post contributors aren’t staff, but may write articles or columns. In some cases, contributors are sources or experts quoted in a story.

Washington Post reporters or editors recommend this comment or reader post.

You must be logged in to report a comment.

You must be logged in to recommend a comment.

Comments our editors find particularly useful or relevant are displayed in Top Comments . as are comments by users with these badges: . Replies to those posts appear here, as well as posts by staff writers.

All comments are posted in the All Comments tab.

To pause and restart automatic updates, click "Live" or "Paused". If paused, you'll be notified of the number of additional comments that have come in.

Comments our editors find particularly useful or relevant are displayed in Top Comments . as are comments by users with these badges: . Replies to those posts appear here, as well as posts by staff writers.

Dilatrend, Dilatrend

Dilatrend

Important Notice: The Drugs. com international database is in BETA release. This means it is still under development and may contain inaccuracies. It is not intended as a substitute for the expertise and judgement of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that the use of any medication in any country is safe, appropriate or effective for you. Consult with your healthcare professional before taking any medication.

Was this page helpful?

Amitriptyline (Elavil) Drug Information - Indications, Dosage, Side Effects And Precautions, Tryptom

Amitriptyline - Drug Information

Category C :

Animal studies have shown adverse effects on the fetus and there are no appropriate studies in pregnant women, but potential benefits may allow the use of the drug in pregnant women despite the potential for risks.

Dosage & When it is to be taken (Indications):

Adult: PO - Depression - Initial:50-75 mg/day; up to 150 mg/day if needed. Max: 300 mg/day in severe cases. Neuropathic pain - Initial: 10-25 mg/day at night, up to 75 mg/day if needed. Migraine prophylaxis - Initial: 10 mg/day at night. Maintenance: 50-75 mg/day at night.

How it should be taken :

It comes as a tablet, to take by mouth, with or without food.

Warnings and Precautions :

Caution should be exercised in patients with history of irregular heartbeat, heart disease, chest pain, liver disease, prostate problems, overactive thyroid, urinary retention, suicidal thoughts, alcohol addiction, any allergy, who are taking other medications, elderly, during pregnancy and breastfeeding. It may cause dizziness, drowsiness or blurred vision, do not drive a car or operate machinery, get up slowly from bed while taking this medication. Avoid alcohol consumption. Patient may develop with involuntary muscle movements; if it so consult with your doctor immediately. Avoid prolonged exposure to sunlight. It may cause heatstroke, protect from hot weather.

Side Effects :

Body as a Whole - Lupus-like syndrome. Liver - Liver failure. Heart - Heart attack, stroke, nonspecific ECG changes, heart block, irregular heartbeat, low/high blood pressure, fainting, fast heart rate and palpitations. Central Nervous System - Coma, seizures, hallucinations, delusions, confusion, disorientation, in coordination, unsteadiness, tremors, nerve disease, numbness, tingling, involuntary movements, poor concentration, excitement, anxiety, sleeplessness, restlessness, abnormal dreams, drowsiness, dizziness, weakness, fatigue and headache. Allergic - Skin rash, hives, photosensitivity, swelling of the face and tongue. Blood - Bone marrow depression including decreased blood cell counts and bruising. Gastrointestinal - Nausea, vomiting, loss of appetite, mouth ulcer, peculiar taste and diarrhea. Eye and ENT - Blurred vision, dim vision, increased eye pressure, dilatation of pupil and dry mouth. Genitourinary - Testicular swelling and breast enlargement in males, spontaneous flow of milk from the nipple in females, increased or decreased sexual drive, impotence, urinary retention and lowered blood sugar levels. Miscellaneous - Hair loss, weight gain or loss, urinary frequency and increased sweating.

Other Precautions :

This medication may develop with increased risk of suicidal thoughts in children and teenagers; watch them carefully. Monitor blood sugar level regularly while taking this medication.

Storage Conditions :

Store it at room temperature, and in an airtight container. Keep away from children.

Schedule. H

Prescription drugs - Drugs to be sold only under the prescription of a Registered Medical Practitioner.

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.

Does anyone has extensive medicines list in excel sheet format? GABHIJEET Saturday, April 5, 2014

i am using this drug(amitriptyline) 10mg daily at bed time for past few months for insomnia. this has suited me very well without any side affects. my age is 70yrs. i have explored many other options but failed to get good sleep. please advise whether i can continue this dosage for long term use chenna123 Sunday, March 17, 2013

IT ACAUSES CONSTIPATION. WHAT IS TH SOLUTION? harbhajan Wednesday, June 13, 2012

Cardura - Fda Prescribing Information, Side Effects And Uses, Cardular

Cardura

Benign Prostatic Hyperplasia (BPH)

Cardura is indicated for the treatment of the signs and symptoms of BPH.

Hypertension

Cardura is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e. g. on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Cardura may be used alone or in combination with other antihypertensives.

Cardura Dosage and Administration

Dosing Information

Following the initial dose and with each dose increase of Cardura, monitor blood pressure for at least 6 hours following administration. If Cardura administration is discontinued for several days, therapy should be restarted using the initial dosing regimen.

Benign Prostatic Hyperplasia

The recommended initial dosage of Cardura is 1 mg given once daily either in the morning or evening.

Depending on the individual patient's urodynamics and BPH symptomatology, the dose may be titrated at 1 to 2 week intervals to 2 mg, and thereafter to 4 mg and 8 mg once daily. The maximum recommended dose for BPH is 8 mg once daily.

Routinely monitor blood pressure in these patients.

Hypertension

The initial dosage of Cardura is 1 mg given once daily. Daily dosage may be doubled up 16 mg once daily, as needed, to achieve the desired reduction in blood pressure.

Dosage Forms and Strengths

Tablets (scored): 1 mg (white), 2 mg (yellow), 4 mg (orange) or 8 mg (green).

Contraindications

The use of Cardura is contraindicated in patients with a hypersensitivity to doxazosin, other quinazolines (e. g. prazosin, terazosin), or any of its components.

Warnings and Precautions

Postural Hypotension

Postural hypotension with or without symptoms (e. g. dizziness) may develop within a few hours following administration of Cardura. However, infrequently, symptomatic postural hypotension has also been reported later than a few hours after dosing. As with other alpha-blockers, there is a potential for syncope, especially after the initial dose or after an increase in dosage strength. Advise patient how to avoid symptoms resulting from postural hypotension and what measures to take should they develop.

Concomitant administration of Cardura with a PDE-5 inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension.

Cataract Surgery

Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha 1 blockers. This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient's surgeon should be prepared for possible modifications to their surgical technique, such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. There does not appear to be a benefit of stopping alpha 1 blocker therapy prior to cataract surgery.

Prostate Cancer

Carcinoma of the prostate causes many of the symptoms associated with BPH and the two disorders frequently co-exist. Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with Cardura for the treatment of BPH.

Priapism

Alpha1 antagonists, including doxazosin, have been associated with priapism (painful penile erection, sustained for hours and unrelieved by sexual intercourse or masturbation). This condition can lead to permanent impotence if not promptly treated.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Benign Prostatic Hyperplasia (BPH)

The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 2) are based on combined data from seven placebo-controlled trials involving once-daily administration of Cardura in doses of 1 to 16 mg in hypertensives and 0.5 to 8 mg in normotensives. Adverse reactions occurring more than 1% more frequently in BPH patients treated with Cardura vs placebo are summarized in Table 1.

Table 1. Adverse Reactions Occurring more than 1% More Frequently in BPH Patients Treated with Cardura Versus Placebo

Other adverse reactions occurring less than 1% more frequently in BPH patients treated with Cardura vs placebo but plausibly related to Cardura include: palpitations.

Cardura has been administered to approximately 4000 hypertensive patients in clinical trials, of whom 1679 were included in the hypertension clinical development program. In placebo-controlled studies, adverse events occurred in 49% and 40% of patients in the doxazosin and placebo groups, respectively, and led to discontinuation in 2% of patients in each group.

Adverse reactions occurring more than 1% more frequently in hypertensive patients treated with Cardura vs placebo are summarized in Table 1. Postural effects and edema appeared to be dose-related. The prevalence rates presented below are based on combined data from placebo-controlled studies involving once-daily administration of doxazosin at doses ranging from 1 to 16 mg.

Table 2. Adverse Reactions Occurring more than 1% More Frequently in Hypertensive Patients Treated with Cardura versus Placebo

NERVOUS SYSTEM DISORDERS

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS

RENAL AND URINARY DISORDERS

REPRODUCTIVE SYSTEM AND BREAST DISORDERS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS

Other adverse reactions occurring less than 1% more frequently in hypertensive patients treated with Cardura vs placebo but plausibly related to Cardura use include vertigo, hypotension, hot flushes, epistaxis and oedema.

Cardura has been associated with decreases in white blood cell counts

Laboratory changes observed in clinical studies

Leukopenia/Neutropenia: Decreases in mean white blood cell (WBC) and mean neutrophil count were observed in controlled clinical trials of hypertensive patients receiving Cardura. In cases where follow-up was available, WBC and neutrophil counts returned to normal after discontinuation of Cardura. No patients became symptomatic as a result of the low WBC or neutrophil counts.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Cardura. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

In post-marketing experience, the following additional adverse reactions have been reported: Blood and Lymphatic System Disorders: leukopenia, thrombocytopenia; Immune System Disorders: allergic reaction; Nervous System Disorders: hypoesthesia; Eye Disorders: Intraoperative Floppy Iris Syndrome [see Warnings and precautions (5.4) ] ; Cardiac Disorders: bradycardia; Respiratory, Thoracic and Mediastinal Disorders: bronchospasm aggravated; Gastrointestinal Disorders: vomiting; Hepatobiliary Disorders: cholestasis, hepatitis cholestatic; Skin and Subcutaneous Tissue Disorders: urticaria; Musculoskeletal and Connective Tissue Disorders: muscle cramps, muscle weakness; Renal and Urinary Disorders: hematuria, micturition disorder, micturition frequency, nocturia; Reproductive System and Breast Disorders: gynecomastia, priapism.

Drug Interactions

. CYP 3A Inhibitors

In vitro studies suggest that doxazosin is a substrate of CYP 3A4. Strong CYP3A inhibitors may increase exposure to doxazosin. Monitor blood pressure and for symptoms of hypotension when Cardura is used concomitantly with strong CYP3A inhibitors [ see Clinical Pharmacology (12.3) ].

Phosphodiesterase-5 (PDE-5) inhibitors

Concomitant administration of Cardura with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension. Monitor blood pressure and for symptoms of hypotension [ see Warnings and Precautions (5.1) ].

USE IN SPECIFIC POPULATIONS

Pregnancy

The limited available data with Cardura in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. However, untreated hypertension during pregnancy can result in increased maternal risks [see Clinical Considerations ]. In animal reproduction studies, no adverse developmental effects were observed when doxazosin was orally administered to pregnant rabbits and rats during the period of organogenesis at doses of up to 41 and 20 mg/kg, respectively (exposures in rabbits and rats were 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose). A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival [see Data ].

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U. S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

Disease-associated maternal and/or embryo/fetal risk

Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e. g. need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.

Radioactivity was found to cross the placenta following oral administration of labelled doxazosin to pregnant rats. Studies in pregnant rabbits and rats at daily oral doses of up to 41 and 20 mg/kg, respectively (plasma drug concentrations of 10 and 4 times, respectively, the human AUC exposures with a 12 mg/day therapeutic dose), have revealed no evidence of adverse developmental effects. A dosage regimen of 82 mg/kg/day in the rabbit was associated with reduced fetal survival. In peri - and postnatal studies in rats, postnatal development at maternal doses of 40 or 50 mg/kg/day of doxazosin (about 8 times human AUC exposure with a 12 mg/day therapeutic dose) was delayed, as evidenced by slower body weight gain and slightly later appearance of anatomical features and reflexes.

Lactation

There is limited information on the presence of Cardura in human milk [see Data ]. There is no information on the effects of Cardura on the breastfeed infant or the effects on milk production.

A single case study reports that Cardura is present in human milk, which resulted in an infant dose of less than 1% of the maternal weight-adjusted dosage and a milk/plasma ratio of 0.1. However, these data are insufficient to confirm the presence of Cardura in human milk.

Pediatric Use

The safety and effectiveness of Cardura have not been established in children.

Geriatric Use

Benign Prostatic Hyperplasia (BPH)

The safety and effectiveness profile of Cardura was similar in the elderly (age ≥ 65 years) and younger (age < 65 years) patients.

Clinical studies of Cardura did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Hepatic Impairment

Cardura is extensively metabolized in the liver. Hepatic impairment is expected to increase exposure to doxazosin. Use of Cardura in patients with severe hepatic impairment (Child-Pugh Class C) is not recommended. Monitor blood pressure and for symptoms of hypotension in patients with lesser degrees of hepatic impairment (Child-Pugh Class A and B) [ see Clinical Pharmacology (12.3) ].

Overdosage

Experience with Cardura overdosage is limited. Two adolescents, who each intentionally ingested 40 mg Cardura with diclofenac or acetaminophen, were treated with gastric lavage with activated charcoal and made full recoveries. A two-year-old child who accidently ingested 4 mg Cardura was treated with gastric lavage and remained normotensive during the five-hour emergency room observation period. A six-month-old child accidentally received a crushed 1 mg tablet of Cardura and was reported to have been drowsy. A 32-year-old female with chronic renal failure, epilepsy, and depression intentionally ingested 60 mg Cardura (blood level = 0.9 mcg/mL; normal values in hypertensives = 0.02 mcg/mL); death was attributed to a grand mal seizure resulting from hypotension. A 39-year-old female who ingested 70 mg Cardura, alcohol, and Dalmane ® (flurazepam) developed hypotension which responded to fluid therapy.

The oral LD 50 of doxazosin is greater than 1000 mg/kg in mice and rats. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of fluid. As doxazosin is highly protein bound, dialysis would not be indicated.

Cardura Description

Cardura ® (doxazosin mesylate) is a quinazoline compound that is a selective inhibitor of the alpha 1 subtype of alpha-adrenergic receptors. The chemical name of doxazosin mesylate is 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-(1,4-benzodioxan-2-ylcarbonyl) piperazine methanesulfonate. The empirical formula for doxazosin mesylate is C 23 H 25 N 5 O 5 ∙ CH 4 O 3 S and the molecular weight is 547.6. It has the following structure:

Cardura (doxazosin mesylate) is freely soluble in dimethylsulfoxide, soluble in dimethylformamide, slightly soluble in methanol, ethanol, and water (0.8% at 25°C), and very slightly soluble in acetone and methylene chloride. Cardura is available as colored tablets for oral use and contains 1 mg (white), 2 mg (yellow), 4 mg (orange) and 8 mg (green) of doxazosin as the free base.

The inactive ingredients for all tablets are: microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate. The 2 mg tablet contains D & C yellow 10 and FD & C yellow 6; the 4 mg tablet contains FD & C yellow 6; the 8 mg tablet contains FD & C blue 2 and D & C yellow 10.

Cardura - Clinical Pharmacology

Mechanism of Action

Benign Prostatic Hyperplasia (BPH)

The symptoms associated with benign prostatic hyperplasia (BPH), such as urinary frequency, nocturia, weak stream, hesitancy, and incomplete emptying are related to two components, anatomical (static) and functional (dynamic). The static component is related to an increase in prostate size caused, in part, by a proliferation of smooth muscle cells in the prostatic stroma. However, the severity of BPH symptoms and the degree of urethral obstruction do not correlate well with the size of the prostate. The dynamic component of BPH is associated with an increase in smooth muscle tone in the prostate and bladder neck. The degree of tone in this area is mediated by the alpha 1 adrenoceptor, which is present in high density in the prostatic stroma, prostatic capsule and bladder neck. Blockade of the alpha 1 receptor decreases urethral resistance and may relieve the obstruction and BPH symptoms and improve urine flow.

The mechanism of action of Cardura is selective blockade of the alpha 1 (postjunctional) subtype of adrenergic receptors. Studies in normal human subjects have shown that doxazosin competitively antagonized the pressor effects of phenylephrine (an alpha 1 agonist) and the systolic pressor effect of norepinephrine. Doxazosin and prazosin have similar abilities to antagonize phenylephrine. The antihypertensive effect of Cardura results from a decrease in systemic vascular resistance. The parent compound doxazosin is primarily responsible for the antihypertensive activity. The low plasma concentrations of known active and inactive metabolites of doxazosin (2-piperazinyl, 6'- and 7'-hydroxy and 6- and 7-O-desmethyl compounds) compared to parent drug indicate that the contribution of even the most potent compound (6'-hydroxy) to the antihypertensive effect of doxazosin in man is probably small. The 6'- and 7'-hydroxy metabolites have demonstrated antioxidant properties at concentrations of 5 µM, in vitro .

Pharmacodynamics

Benign Prostatic Hyperplasia (BPH)

Administration of Cardura to patients with symptomatic BPH resulted in a statistically significant improvement in maximum urinary flow rate [see Clinical Studies (14.1) ] .

Effect on Normotensive Patients with Benign Prostatic Hyperplasia (BPH)

Although blockade of alpha 1 adrenoceptors also lowers blood pressure in hypertensive patients with increased peripheral vascular resistance, Cardura treatment of normotensive men with BPH did not result in a clinically significant blood pressure lowering effect (Table 4). The proportion of normotensive patients with a sitting systolic blood pressure less than 90 mmHg and/or diastolic blood pressure less than 60 mmHg at any time during treatment with Cardura 1–8 mg once daily was 6.7% with doxazosin and not significantly different (statistically) from that with placebo (5%).

Administration of Cardura results in a reduction in systemic vascular resistance. In patients with hypertension, there is little change in cardiac output. Maximum reductions in blood pressure usually occur 2–6 hours after dosing and are associated with a small increase in standing heart rate. Like other alpha 1 - adrenergic blocking agents, doxazosin has a greater effect on blood pressure and heart rate in the standing position.

Pharmacokinetics

After oral administration of therapeutic doses, peak plasma levels of Cardura occur at about 2–3 hours. Bioavailability is approximately 65%, reflecting first-pass metabolism of doxazosin by the liver. The effect of food on the pharmacokinetics of Cardura was examined in a crossover study with twelve hypertensive subjects. Reductions of 18% in mean maximum plasma concentration (C max ) and 12% in the area under the concentration-time curve (AUC) occurred when Cardura was administered with food. Neither of these differences is clinically significant.

In a crossover study in 24 normotensive subjects, the pharmacokinetics and safety of doxazosin were shown to be similar with morning and evening dosing regimens. The AUC after morning dosing was, however, 11% less than that after evening dosing and the time to peak concentration after evening dosing occurred significantly later than that after morning dosing (5.6 vs. 3.5 hours).

At the plasma concentrations achieved by therapeutic doses, approximately 98% of the circulating drug is bound to plasma proteins.

Cardura is extensively metabolized in the liver, mainly by O-demethylation of the quinazoline nucleus or hydroxylation of the benzodioxan moiety. In vitro studies suggest that the primary pathway for elimination is via CYP 3A4; however, CYP 2D6 and CYP 2C9 metabolic pathways are also involved to a lesser extent. Although several active metabolites of doxazosin have been identified, the pharmacokinetics of these metabolites have not been characterized.

Plasma elimination of doxazosin is biphasic, with a terminal elimination half-life of about 22 hours. Steady-state studies in hypertensive patients given doxazosin doses of 2 to 16 mg once daily showed linear kinetics and dose proportionality. In two studies, following the administration of 2 mg orally once daily, the mean accumulation ratios (steady-state AUC vs. first-dose AUC) were 1.2 and 1.7. Enterohepatic recycling is suggested by secondary peaking of plasma doxazosin concentrations.

In a study of two subjects administered radiolabelled doxazosin 2 mg orally and 1 mg intravenously on two separate occasions, approximately 63% of the dose was eliminated in the feces and 9% of the dose was found in the urine. On average only 4.8% of the dose was excreted as unchanged drug in the feces and only a trace of the total radioactivity in the urine was attributed to unchanged drug.

The pharmacokinetics of Cardura in young (<65 years) and elderly (≥65 years) subjects were similar for plasma half-life values and oral clearance.

Pharmacokinetic studies in elderly patients and patients with renal impairment have shown no significant alterations compared to younger patients with normal renal function.

Administration of a single 2 mg dose to patients with cirrhosis (Child-Pugh Class A) showed a 40% increase in exposure to doxazosin. The impact of moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment on the pharmacokinetics of doxazosin is not known [see Use in Specific Populations (8.6) ] .

There are only limited data on the effects of drugs known to influence the hepatic metabolism of doxazosin (e. g. cimetidine).

Cimetidine: In healthy volunteers, the administration of a single 1 mg dose of doxazosin on day 1 of a four-day regimen of oral cimetidine (400 mg twice daily) resulted in a 10% increase in mean AUC of doxazosin, and a slight but not significant increase in mean Cmax and mean half-life of doxazosin.

In vitro data in human plasma indicate that Cardura has no effect on protein binding of digoxin, warfarin, phenytoin, or indomethacin.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis and Mutagenesis: Chronic dietary administration (up to 24 months) of doxazosin mesylate at maximally tolerated doses of 40 mg/kg/day in rats and 120 mg/kg/day in mice revealed no evidence of carcinogenic potential. The highest doses evaluated in the rat and mouse studies are associated with AUCs (a measure of systemic exposure) that are 8 times and 4 times, respectively, the human AUC at a dose of 16 mg/day.

Mutagenicity studies revealed no drug - or metabolite-related effects at either chromosomal or subchromosomal levels.

Fertility in Males. Studies in rats showed reduced fertility in males treated with doxazosin at oral doses of 20 (but not 5 or 10) mg/kg/day, about 4 times the AUC exposures obtained with a 12 mg/day human dose. This effect was reversible within two weeks of drug withdrawal. There have been no reports of any effects of doxazosin on male fertility in humans.

Animal Toxicology and Pharmacology

An increased incidence of myocardial necrosis or fibrosis was observed in long-term (6–12 months) studies in rats and mice (exposure 8 times human AUC exposure in rats and somewhat equivalent to human Cmax exposure in mice). Findings were not seen at lower doses. In dogs no cardiotoxicity was observed following 12 months of oral dosing at doses that resulted in maximum plasma concentrations (C max) 14 times the C max exposure in humans receiving a 12 mg/day therapeutic dose or in Wistar rats at C max exposures 15 times human C max exposure. There is no evidence that similar lesions occur in humans.

Clinical Studies

Benign Prostatic Hyperplasia (BPH)

The efficacy of Cardura was evaluated extensively in over 900 patients with BPH in double-blind, placebo-controlled trials. Cardura treatment was superior to placebo in improving patient symptoms and urinary flow rate. Significant relief with Cardura was seen as early as one week into the treatment regimen, with Cardura-treated patients (N=173) showing a significant (p<0.01) increase in maximum flow rate of 0.8 mL/sec compared to a decrease of 0.5 mL/sec in the placebo group (N=41). In long-term studies, improvement was maintained for up to 2 years of treatment. In 66–71% of patients, improvements above baseline were seen in both symptoms and maximum urinary flow rate.

In three placebo-controlled studies of 14–16 weeks' duration, obstructive symptoms (hesitation, intermittency, dribbling, weak urinary stream, incomplete emptying of the bladder) and irritative symptoms (nocturia, daytime frequency, urgency, burning) of BPH were evaluated at each visit by patient-assessed symptom questionnaires. The bothersomeness of symptoms was measured with a modified Boyarsky questionnaire. Symptom severity/frequency was assessed using a modified Boyarsky questionnaire or an AUA-based questionnaire. Uroflowmetric evaluations were performed at times of peak (2–6 hours post-dose) and/or trough (24 hours post-dose) plasma concentrations of Cardura.

The results from the three placebo-controlled studies (N=609) showing significant efficacy with 4 mg and 8 mg doxazosin are summarized in Table 3. In all three studies, Cardura resulted in statistically significant relief of obstructive and irritative symptoms compared to placebo. Statistically significant improvements of 2.3–3.3 mL/sec in maximum flow rate were seen with Cardura in Studies 1 and 2, compared to 0.1–0.7 mL/sec with placebo.

In one fixed-dose study (Study 2), Cardura therapy (4 to 8 mg, once daily) resulted in a significant and sustained improvement in maximum urinary flow rate of 2.3–3.3 mL/sec (Table 3) compared to placebo (0.1 mL/sec). In this study, the only study in which weekly evaluations were made, significant improvement with Cardura vs. placebo was seen after one week. The proportion of patients who responded with a maximum flow rate improvement of ≥3 mL/sec was significantly larger with Cardura (34–42%) than placebo (13–17%). A significantly greater improvement was also seen in average flow rate with Cardura (1.6 mL/sec) than with placebo (0.2 mL/sec). The onset and time course of symptom relief and increased urinary flow from Study 1 are illustrated in Figure 1.

Figure 1 – Study 1

Hypertension

In a pooled analysis of placebo-controlled hypertension studies with about 300 hypertensive patients per treatment group, doxazosin, at doses of 1 to 16 mg given once daily, lowered blood pressure at 24 hours by about 10/8 mmHg compared to placebo in the standing position and about 9/5 mmHg in the supine position. Peak blood pressure effects (1–6 hours) were larger by about 50–75% (i. e. trough values were about 55–70% of peak effect), with the larger peak-trough differences seen in systolic pressures. There was no apparent difference in the blood pressure response of Caucasians and blacks or of patients above and below age 65. In the same patient population, patients receiving Cardura gained a mean of 0.6 kg compared to a mean loss of 0.1 kg for placebo patients.

TABLE 4 Mean Changes in Blood Pressure from Baseline to the Mean of the Final Efficacy Phase in Normotensives (Diastolic BP <90 mmHg) in Two Double-blind, Placebo-controlled U. S. Studies with Cardura 1 to 8 mg once daily.

Recommended Storage: Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Advise patients of the possibility of syncopal and orthostatic symptoms, especially at the initiation of therapy, and urged to avoid driving or hazardous tasks for 24 hours after the first dose, after a dosage increase, and after interruption of therapy when treatment is resumed. Advise patients to report symptoms to their healthcare provider.

Advise patients of the possibility of priapism and to seek immediate medical attention if symptoms occur.

This product's label may have been updated. For full prescribing information, please visit www. pfizer. com.

This Patient Information has been approved by the U. S. Food and Drug Administration

PATIENT INFORMATION Cardura ® (kar-DUR-a) (doxazosin mesylate tablets)

What is Cardura?

Cardura is a prescription medicine that contains doxazosin mesylate and is called an "alpha-blocker". Cardura is used to treat:

the symptoms of benign prostatic hyperplasia (BPH)

high blood pressure (hypertension)

It is not known if Cardura is safe and effective in children.

Who should not take Cardura?

Do not take Cardura if you.

are allergic to doxazosin, other quinazolines, or any of the ingredients in Cardura. See the end of this Patient Information leaflet for a complete list of ingredients in Cardura.

What should I tell my healthcare provider before taking Cardura?

Before taking Cardura, tell your healthcare provider about all of your medical conditions, including if you.

have had low blood pressure, especially after taking other medicine. Signs of low blood pressure include fainting, dizziness, and lightheadedness.

have any planned eye surgery

have prostate cancer or a history of prostate cancer. Your healthcare provider may have you checked for prostate cancer before you start taking and while you take Cardura.

have liver problems

are pregnant or plan to become pregnant. It is not known if Cardura will harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if Cardura passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby if you take Cardura.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Cardura may affect the way other medicines work, and other medicines may affect the way Cardura works causing side effects.

Especially tell your healthcare provider if you take:

other medicine for high blood pressuremedicine to treat erectile dysfunction (ED) called a phosphodiesterase type 5 (PDE-5) inhibitor. The use of Cardura with PDE-5 inhibitors can lead to a drop in blood pressure or to fainting.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Cardura?

Take Cardura exactly as your healthcare provider tells you to take it.

Your healthcare provider will tell you how much Cardura to take and when to take it.

Your healthcare provider may need to change your dose of Cardura until it is the right dose for you.

What should I avoid while taking Cardura?

Do not drive or perform any hazardous task until at least 24 hours after you have taken Cardura if you are taking:

your first dose of Cardura

Cardura for the first time after your healthcare provider has increased your dose of Cardura

Cardura for the first time after any breaks (interruptions) in your treatment with Cardura

What are the possible side effects of Cardura?

Cardura may cause serious side effects, including.

A sudden drop in blood pressure. especially when you first start treatment or when there is an increase in your dose of Cardura, is common but can also be serious. This may cause you to faint, or to feel dizzy or lightheaded. Your risk of having this problem may be increased if you take Cardura with certain other medicines that lower blood pressure including PDE-5 inhibitors. Your healthcare provider may monitor your blood pressure while you take Cardura. See "What should I avoid while taking Cardura? "

Eye problems during cataract surgery. A condition called Intraoperative Floppy Iris Syndrome (IFIS) can happen during cataract surgery if you take or have taken alpha-blockers such as Cardura. If you need to have cataract surgery, be sure to tell your healthcare provider if you take or have taken Cardura.

A painful erection that will not go away. Cardura can cause a painful erection (priapism), which cannot be relieved by having sex. If this happens, get medical help right away. If priapism is not treated, you may not be able to get an erection in the future.

The most common side effects of Cardura are:

weakness or lack of energy (asthenia)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Cardura. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Cardura.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Cardura for a condition for which it was not prescribed. Do not give Cardura to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Cardura. For more information, ask your healthcare provider. You can ask your healthcare provider or pharmacist for information that is written for healthcare professionals.

What are the ingredients in Cardura?

Active ingredient: doxazosin mesylate

Inactive ingredients: microcrystalline cellulose, lactose, sodium starch glycolate, magnesium stearate and sodium lauryl sulfate.

Chloroquine Malaria Tablets, Malarivon

Chloroquine tablets and liquid medicine (Avloclor, Malarivon)

Tablets and liquid medicine

Chloroquine is mainly used to protect against malaria when people travel to areas where this can be a problem. It is usually used in combination with another antimalarial medicine to increase its effectiveness. It is also used to treat people who have a form of malaria called non-falciparum malaria.

Malaria is a serious infection. It is common in tropical countries such as parts of Africa, Asia, South and Central America, and the Middle East. Malaria is a disease which is passed on to humans by infected mosquitoes. A parasite called plasmodium lives inside the stomachs of infected female mosquitoes and is passed on to humans by a bite.

Because the pattern of malaria varies with the part of the world you are travelling to, as well as the season and the type of activity you have planned, you should always obtain the latest advice about malaria prevention from your doctor, pharmacist or travel organiser. A backpacking trip may well require different preventative measures against malaria to those needed for a business trip to a city.

Chloroquine is not prescribable on the NHS in order to prevent malaria, but you are able to buy the tablets at pharmacies, without a prescription, for this purpose.

Chloroquine is available on prescription to treat rheumatoid arthritis and lupus erythematosus. although other treatments are usually preferred. These are both autoimmune diseases. This means that your immune system (which normally protects your body from infections) mistakenly attacks itself. This causes pain and damage to parts of your body. Chloroquine is used in some people to help reduce the damage these conditions can cause.

Related discussions

Worms in the Face

Before taking chloroquine

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking chloroquine it is important that your doctor or pharmacist knows:

If you are pregnant or breast-feeding. Travel to areas with malaria is best avoided during pregnancy. If the travel is unavoidable, you will be advised to take chloroquine even if you are pregnant.

If you have any problems with the way your kidneys work, or any problems with the way your liver works.

If you have ever had epilepsy.

If you have a skin condition called psoriasis.

If you have a condition which causes severe muscle weakness, called myasthenia gravis.

If you have problems with your stomach or intestines.

If you have either of these rare inherited conditions: a blood disorder called porphyria, or glucose-6-phosphate dehydrogenase (G6PD) deficiency (this is a disorder which causes problems after eating some foods, such as fava beans).

If you are taking any other medicines. This includes any medicines which are available to buy without a prescription, as well as herbal and complementary medicines.

If you have ever had an allergic reaction to a medicine.

How to take chloroquine

Before you take chloroquine, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about the medicine, and will also provide you with a full list of the side-effects which you could experience from taking it.

It is important that you take chloroquine exactly as you have been directed. Your doctor or pharmacist will tell you how much to take, and how often to take it. The directions will also be printed on the label of the pack to remind you about what was said to you. Chloroquine should be taken with food. Swallow the tablets with a drink of water.

If you take a medicine for indigestion (such as an antacid), do not take it within two hours, either before or after, of taking chloroquine. This is because antacids interfere with the way chloroquine is absorbed by your body, making it less effective.

If you have been advised to have an oral vaccine to protect you against typhoid, you should arrange to have this so your course is finished at least three days before you start taking chloroquine. This is because chloroquine can stop the vaccine from working properly.

If you suspect that you have taken an overdose of chloroquine, or that someone else (especially if it is a child) might have taken it accidentally, go to the accident and emergency department of a local hospital straightaway . This is very important because chloroquine can cause serious problems when it is taken accidentally or in overdose. Take the container with you to show what has been taken, even if the pack is now empty.

If you are taking chloroquine to protect against malaria

You should take the first dose of chloroquine a week before entering an area where malaria occurs. This is to ensure there is sufficient medicine in your bloodstream to give you the required protection. You should continue to take chloroquine throughout your stay and for a further four weeks after you have left the area.

Take the tablets (or medicine) exactly as your doctor or pharmacist has told you. The dose for an adult is two tablets once a week . on the same day of the week. If the chloroquine is for a child, read the directions on the label carefully, as their dose will depend upon their age and weight.

If you forget to take a dose on the correct day, take it as soon as you remember and then wait seven days before you take your next dose.

You should complete the full course of tablets (or medicine). This means making sure that you remember to take chloroquine for four weeks after your visit is over.

Chloroquine will help reduce the risk of you getting malaria, but it is also important that you take the following precautions against being bitten by mosquitoes:

Cover up bare areas of your arms and legs with long-sleeved, loose-fitting clothing, long trousers and socks. This is especially important if you are outside after sunset, as this is when mosquitoes feed.

Use an effective insect repellant spray on your clothing and any area of your skin which is bare. If you are also using a sunscreen, apply the sunscreen first and the insect repellant afterwards.

Spray the room with an insecticide each evening a couple of hours before you go to bed. Check your sleeping areas for mosquitoes - pay particular attention to furniture and areas under your bed where insects can hide.

If you are sleeping in an unscreened room, use a mosquito net impregnated with an insecticide.

If you feel ill or develop a high temperature (fever) or flu-like symptoms while you are travelling or within one year (especially if it is within three months) of returning home, you should see your doctor straightaway. This is important, even if you have taken your antimalarial tablets correctly.

If you are taking chloroquine for rheumatoid arthritis or lupus erythematosus

It is usual to take chloroquine once daily, although some people could be advised to take it twice daily for a short period of time. Your dose will be adjusted to suit you, so it is important that you follow the directions given to you by your doctor or specialist; for most people the dose is likely to be one tablet a day. The directions will be printed on the label of the pack to remind you about what the doctor said to you.

Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress. Your doctor is likely to check your vision before you start the treatment, and then regularly thereafter. This is because chloroquine can affect your eyesight when taken over a long period of time. If you notice any changes in your vision, you should inform your doctor as soon as possible so that it can be checked.

If you forget to take a dose, take it as soon as you remember. If you do not remember until the following day, leave out the forgotten dose from the previous day and take the dose that is due as normal. Do not take two doses on the same day to make up for a missed dose.

Can chloroquine cause problems?

All medicines can cause unwanted side-effects along with their useful effects, although not everyone experiences them. The unwanted effects usually improve as your body adjusts to the new medicine. When chloroquine is used to prevent malaria, side-effects are generally uncommon and not serious. Where chloroquine is taken for a long time, side-effects can be more serious. Speak with your doctor or pharmacist if any of the following continue or become troublesome:

What can I do if I experience this?

Dialgirex, Dialgirex

Why register with MediGuard?

We are a free monitoring service designed for patients like you who want to be in the driving seat of your medical treatment. We have a community of more than 2.6 million members and offer the services below.

Medication Information Personalised Risk Rating Easy to understand overview Serious Side Effects Printable Medication List

Information you can understand Overview on Safety Alerts & Recalls Overview of Medications & Conditions

Community of patients Members’ Feedback Members Treatment Satisfaction

Health condition information Easy to understand overview Commonly Used Medications

Safety checks Safety Alerts & Recalls Drug - Drug Interaction Drug - Condition Interaction

Research participation Option to participate in medical surveys & studies*

Dialgirex (Propoxyphene HCl and Acetaminophen)

[ 1 2 3 4 5 6 7 8 9 10 30 ]