In primary prevention intervention the effects of simvastatin induced changes in. Please read section 3 of the package leaflet pl for detailed information on dosing. Precautions and warnings of simvastatin drugs home page. Simvastatin 40mg tablets patient information leaflet pil. Find patient medical information for simvastatin oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Zocor simvastatin dose, indications, adverse effects. Refer to the specific manufacturers prescribing information for administration and. Highlights of prescribing information these highlights do not include all the information needed to use zocor safely and effectively. Pdf ezetimibesimvastatin is a combination of a statin and a cholesterol absorption inhibitor. Pdf statins are widely used and well tolerated cholesterollowering drugs, and.
This leaflet does not take the place of talking with your doctor about your condition or treatment. These highlights do not include all the information needed to use. Simvastatin oral suspension drug name simvastatin 20 mg5 ml and 40 mg5 ml oral suspension indication for patients unableunwilling to swallow simvastatin tablets. Recommendations for management of clinically significant drug. Lipitor is for adults and children over 10 whose cholesterol does not come down enough with exercise and a lowfat diet alone. The researchers found that treatment with simvastatin ezetimibe resulted in lower rates of the primary end point composite of death due to cardiovascular disease, myocardial infarction, stroke, unstable angina requiring hospitalization, and coronary revascularization after 30 days versus simvastatin alone.
Updated october 2014 page 1 package insert template for simvastatin tablet brand or product name product name tablet 10mg product name tablet 20mg product name tablet 40mg product name tablet 80mg name and strength of active substances. Simvastatin definition of simvastatin by the free dictionary. Zocor simvastatin is a drug prescribed to reduce triglycerides, total cholesterol ldl, and increasing hdl cholesterol. It is also used to decrease the risk of heart problems in those at high risk. Simvastatin tablets should be used as an adjunct to other lipidlowering treatments e.
It lowers the ldlc bad cholesterol and triglycerides in your blood. Information about crestor rosuvastatin calcium, a prescription cholesterol medicine that helps lower ldl cholesterol when diet and exercise alone are not enough. A 72yearold white man with underlying human immunodeficiency virus, atrial fibrillation, coronary artery disease, and hyperlipidemia presented with generalized pain, fatigue, and dark orange urine for 3 days. Statins are medications that work by reducing the amount of cholesterol made by the liver. As this emedtv page explains, there are many precautions and warnings of simvastatin to be aware of. Dispense in a tight, lightresistant container as defined in the usp, with a childresistant closure as required. Learn about its side effects, dosage, uses, and more. Simvastatin definition, a statin, c25h38o5, used in the prevention and treatment of heart disease. Eq 20mg base federal register determination that product was not discontinued or withdrawn for safety or efficacy reasons. The cause of the increased risk of myopathy is not known.
A statin drug, c25h38o5, that blocks the bodys synthesis of cholesterol and is used to lower cholesterol levels and to reduce the risk of heart attack. Simvastatin is used together with diet, weightloss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Commercialhealthcare exchange pa criteria effective. Learn about how prevymis may be able to help keep you from getting sick from cmv, and talk to your doctor to see if prevymis is right for you. Highlights of prescribing information these highlights do not. Simvastatin, marketed under the trade name zocor among others, is a lipidlowering medication. Simvastatin is an inactive lactone, and is hydrolysed to its active form, the corresponding betahydroxyacid, after oral ingestion. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for lipitor atorvastatin. How is this medicine simvastatin tablets best taken. Ezetimibe 10 mgsimvastatin 40 mg tablets vytorin 1080 ezetimibe 10 mgsimvastatin 80 mg tablets description vytorin contains ezetimibe, a selective inhibitor of intestinal cholesterol and related phytosterol absorption, and simvastatin, a 3hydroxy3methylglutarylcoenzyme a hmgcoa reductase inhibitor. Cardiovascular risk associated with rapid infusion rates see full prescribing information for complete boxed warning the rate of intravenous cerebyx administration should not exceed 150 mg phenytoin sodium equivalents pe per minute in adults and 2 mg pekgmin or 150 mg pemin, whichever is slower in pediatric patients because of the risk of severe hypotension and. Simvastatin prodrug compared with its hydrolysis product and pravastatin. Simvastatin is a, fda approved prescription medication that is used along with a proper diet to help lower bad cholesterol and fats such as ldl, triglycerides and raise good cholesterol in the blood.
Among other warnings, this page covers the safety of taking simvastatin if you are pregnant or nursing, or drink alcohol or grapefruit juice often. Pdf lipidlowering effects of ezetimibe and simvastatin in. The pharmaceutical company has decided to discontinue this product. This supplemental new drug application proposes changes in the format of the pravachol package insert in response to the physicians labeling rule plr. The majority of prescription orders written in the united states are filled with generic alternatives. Onmel fda prescribing information, side effects and uses. Severe rhabdomyolysis and acute renal failure secondary to. Lipitor is a prescription medicine that lowers cholesterol in the blood. Drug administration has registered 601 cases of statin. The following conditions are contraindicated with this drug.
Fetal toxicity when pregnancy is detected, discontinue amlodipine, valsartan and hydrochlorothiazide as soon as possible. Information for the user simvastatin 10 mg filmcoated tablets simvastatin 20 mg filmcoated tablets simvastatin 40 mg filmcoated tablets simvastatin 80 mg filmcoated tablets simvastatin read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This lack of a pharmacokinetic interaction between simvastatin and fenofibrate relaxed the recommendation in the package insert for simvastatin. Simvastatin, fenofibrate, and rhabdomyolysis diabetes care. This lack of a pharmacokinetic interaction between simvastatin and fenofibrate relaxed the. Simvastatin is an effective serum lipidlowering drug that can decrease low density lipoprotein ldl levels by up to 50%.
Read about common and serious side effects of simvastatin. Pdf molecular mechanisms of toxicity of simvastatin, widely used. Highlights of prescribing information these highlights do. Simvastatin definition of simvastatin by medical dictionary. Lipitor is a prescription medicine that lowers cholesterol in your blood. Common side effects of zocor include diarrhea, vomiting, headache, and abdominal pain.
The role of statins in both cognitive impairment and protection. Jan 01, 2019 onmel is indicated for the treatment of onychomycosis of the toenail due to trichophyton rubrum or t. It is used along with exercise, diet, and weight loss to decrease elevated lipid levels. If you have further questions, ask your doctor or pharmacist. Simvastatin is a potent cholesterol lowering drug that may carry myalgia as a side.
Check with your physician if you have any of the following. Simvastatin is fdaapproved for the treatment of heterozygous familial hypercholesterolemia and is recommended for hyperlipidemia when either. Dose conversion table for statins benefits english. Amlodipine, valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents. Cardiovascular risk associated with rapid infusion rates see full prescribing information for complete boxed warning the rate of intravenous cerebyx administration should not exceed 150 mg phenytoin sodium equivalents pe per minute in adults and 2 mg pekgmin or 150 mg pemin, whichever is slower in pediatric patients because of the risk of severe hypotension and cardiac. Simvastatin, a cholesterollowering agent, is a synthetic derivative of a fermentation product of aspergilius terreus. Module 1 administrative and prescribing information. The recommended dosage for patients with homozygous familial hypercholesterolemia is simvastatin 40 mgday in. To report a case of a severe interaction between simvastatin, amiodarone, and atazanavir resulting in rhabdomyolysis and acute renal failure. Aposimvastatin definition of aposimvastatin by medical. Moreover, the food and drug administration fda addressed the. Simvastatin fda prescribing information, side effects. Keep taking this medicine simvastatin tablets as you have been told by your doctor or other health care provider, even if you feel well.
Package insert template for simvastatin tablet brand or. Because the risk for myopathy is doserelated, chinese patients should not receive simvastatin 80 mg coadministered with lipidmodifying doses of niacincontaining products. Proprietary name tablets cipla simvastatin tablets. Simvastatin zocor is used to treat high cholesterol and to reduce risk of heart disease.
The agreed upon changes to the labeling revisions required in our february 28, 2011 are attached in appendix a. Lipitor atorvastatin calcium fdaapproved patient labeling. Prior to initiating treatment, appropriate nail specimens for laboratory testing koh preparation, fungal culture, or nail biopsy should be obtained to confirm the diagnosis of onychomycosis. The spl will be accessible from publicly available labeling repositories. This information has been left on emc for reference purposes. Pdf to describe a case of newonset cognitive difficulties in an older patient after initiation of simvastatin therapy. The acid form of simvastatin is partly eliminated by glucuronidation and lactonization, both of which are inhibited by gemfibrozil but not fenofibrate 2. In primary prevention intervention the effects of simvastatininduced changes in. Ramipril capsules can only be obtained with a prescription. Hyperladder in lanes 1 and 25 allows estimation of insert length.
Simvastatin 40mg tablets patient information leaflet. Mar 22, 2018 the pharmaceutical company has decided to discontinue this product. Simvastatin tablets for oral administration contain either 10 mg, 20 mg, 40 mg or 80 mg of. Use this medicine simvastatin tablets as ordered by your doctor.
Simvastatin is a white to offwhite, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Highlights of prescribing information these highlights. Other preparations of this medicine may still be available. Proprietary name tablets cipla simvastatin tablets cipla. Pdf simvastatin sodium salt and fluvastatin interact with human. Drug name active ingredients strength dosage formroute marketing status te code rld rs. Simvastatin exposure is approximately doubled with concomitant use of lomitapide. The acute effects of therapeutic concentrations of simvastatin. Find out more information about prevymis letermovir.
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