AMFASTAT 10
FORMULA: Each film-coated tablet contains:
Simvastatin.................................................... 10 mg
Excipients: Copovidone, Lactose, Microcrystalline cellulose, Ascorbic acid, Anhydrous citric acid, Butylated hydroxytoluene, Colloidal anhydrous silica, Sodium starch glycolate, Magnesium stearate, Opadry II white, Red iron oxide, Yellow iron oxide, Allura red q.s. one tablet.
INDICATIONS
Hypercholesterolaemia
- Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (such as exercise, weight reduction) is inadequate.
- Treatment of homozygous familial hypercholesterol-aemia as an adjunct to diet and other lipid-lowering treatments (e.g. LDL-apheresis) or if such treatments are not appropriate.
Cardiovascular prevention
Reduction of cardiovascular mortality and morbidity in patients with manifest atherosclerotic cardiovascular disease or diabetes mellitus, with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors and other cardioprotective therapy.
DOSAGE AND ADMINISTRATION
- Patients should be placed on a standard cholesterol-lowering diet before initiating simvastatin. In patients with current coronary heart diseases or at high risk of coronary heart diseases, simvastatin can be started simultaneously with diet.
- Starting dose: 5 -10 mg/day, in the evening. Maximum dose: 40 mg/day. Simvastatin should be initiated with minimum effective dosage. Then, dosage can be individualized according to therapeutic goals and patient’s response if necessary. Dosage should be increased gradually with intervals no less than 4 weeks and patients should be closely monitored for drug adverse reactions, especially muscular adverse reactions.
- The dose of simvastatin tablets should not be exceed 10 mg/day if simvastatin is taken concomitantly with verapamil, diltiazem, dronedaron.
- If simvastatin is taken concomitantly with amiodarone, amlodipin or ranolazin, the dosage should be less than 20 mg/day.
CONTRAINDICATIONS
Simvastatin tablets are contraindicated in the following conditions:
- Hypersensitive to any ingredients of drug.
- Active liver diseases or unexplained persistent elevations of serum transaminases.
- Pregnant women or nursing women.
- Concomitant administration of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, posaconazole, gemfibrozil, cyclosporine, and danazol).
WARNINGS and PRECAUTIONS
- Simvastatin may cause elevation of transaminase and creatine kinase levels. This should be considered in the differential diagnosis of chest pain in a patient on therapy with simvastatin.
- It is recommended that liver function tests be performed before the initiation of statin treatment, and thereafter when clinically indicated.
- Before statin therapy, creatine kinase measurements must be performed in patients with conditions such as renal impairment, hypothyroidism, individual or family history of hereditary myopathy, past history of statin or fibrate-induced myopathy, hepatic disease and/or consuming substantial quantities of alcohol, elderly patients (> 70 years old) with predisposing factors for rhabdomyolysis, possible drug interaction and special subjects. The benefit/risk should be considered in these cases and the patients should be carefully monitored during the treatment of statin.
- Statin therapy should not be started for the patients with creatine kinase level > 5 times the upper limit of normal.
- During the statin therapy, patients need to report promptly any unexplained muscle pain, tenderness or weakness… If symptoms occur, creatine kinase test must be considered for appropriate
- Caution is required when prescribing a statin drug for patients with high risk of muscular injury. Statin drug may cause adverse reactions to muscular system (such as muscular dystrophy, myositis), particularly in patients with significant risks: more than 65 years of age, incontrollable hypothyroidism, and renal diseases. Closely monitoring is required while taking this drug.
- Avoid grapefruit juice (> 1 litre/day) with simvastatin.
- Co-administration of human immunodeficiency virus (HIV) or hepatitis C virus (HCV) protease inhibitors with simvastatin can increase the risk of muscle injury. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure, which can be fatal.
Pregnancy: since statins decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, they may cause fetal harm when administered to pregnant women. Therefore statins are contraindicated during pregnancy.
Breast-feeding: it is not known whether simvastatin or its metabolites are excreted in human milk. Because many medicinal products are excreted in human milk and because of the potential for serious adverse reactions, women taking simvastatin must not breast-feed their infants.
PRESENTATION: Blister of 10 film-coated tablets, box of 1 blister, 3 blisters and 10 blisters.
Keep out of reach of children
Read the package insert carefully before use
Ask your doctor for further information
Use upon doctor’s prescription only
Manufactured and distributed by: AMPHARCO U.S.A - PHARMACEUTICAL JOINT-STOCK COMPANY
Nhon Trach 3 Industrial Park, Hiep Phuoc ward, Nhon Trach district, Dong Nai province.
Tel: 02513 566 202 - Fax: 02513 566 203