Simvastatin 10-20mg 30 tablets

Composition:
active ingredient: simvastatin;
1 tablet contains simvastatin 10 mg or 20mg;
Excipients: dosing 10mg or 20mg: butylhydroxyanisole (E 320) ascorbic acid; citric acid monohydrate, celactose (mixture of lactose, monohydrate, and powdered cellulose (75:25)) silicon dioxide colloidal potato starch; magnesium stearate hypromellose; kandurin (silver sheen) containing potassium aluminosilicate, titanium dioxide (E 171) Sepispers dry yellow R dye containing hypromellose, microcrystalline cellulose, riboflavin (E 101) polyethylene glycol 4000; titanium dioxide (E 171).

Indications

Hypercholesterolemia Treatment of primary hypercholesterolemia or mixed dyslipidemia as an adjunct to diet when the response to diet and other non-drug treatments (eg exercise, weight reduction) is inadequate.

Treatment of homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering treatments (eg, lipid apheresis low density) or if such treatments are not appropriate.

Cardiovascular prevention: reduction of cardiovascular mortality and morbidity in patients with overt atherosclerotic cardiovascular disease or diabetes with normal or elevated cholesterol levels as an additional therapy for correction of other risk factors and other cardioprotective therapy.

Contraindications

Hypersensitivity to the drug. Liver disease in active phase or unexplained and persistent increase in serum transaminase levels. Concomitant use of strong inhibitors of CYP3A4 (agents that increase AUC approximately 5-fold or more, such as itraconazole, ketoconazole, posakonazol, voriconazole, HIV protease inhibitors (eg, nelfinavir), boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin and nefazodone. Concomitant use of gemfibrozil, cyclosporine or danazol.

Dosage & Administration

The range of dosage – from 5 to 80 mg orally once daily 1 night. Selection of dosage, if required, should be done at intervals of at least 4 weeks to a maximum daily dose of 80 mg, used 1 time per day in the evening. 80 mg dose is only recommended for patients with severe hypercholesterolaemia and high risk for cardiovascular complications who have not reached treatment goals lower doses and when the expected benefit of potential risks prevail.