INEGY (ezetimibe/simvastatin) 10 mg/20 mg 7 Tablets. * Indications: - Primary Hypercholesterolemia: INEGY is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), & non-high-density lipoprotein cholesterol (non-HDL-C), & to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial & non-familial) hypercholesterolemia or mixed hyperlipidemia. - Homozygous Familial Hypercholesterolemia (HoFH): INEGY is indicated for the reduction of elevated total-C levels in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis). * Dosage & Administration: - The patient should be placed on a standard cholesterol-lowering diet before receiving INEGY & should continue on this diet treatment with INEGY. - The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, & response. - INEGY should be taken as a single daily dose in the evening, with or without food. - The dosage range is 10/10 mg/day through 10/80 mg/day. The recommended usual starting dose is 10/20 mg/day. Initiation of therapy with 10/10 mg/day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day. After initiation or titration of INEGY, Lipid levels may be analyzed after 2 or more weeks & dosage adjusted, if needed. - Dosage in Patients with Homozygous Familial Hypercholesterolemia: The recommended dosage is INEGY 10/40 mg/day or 10/80 mg/day in the evening. INEGY should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavailable. - Use in the elderly: No dosage adjustment is required for elderly patients. * Contraindications: - Hypersensitivity to the active substances or to any of the excipients. - Active liver disease or unexplained persistent elevations of serum transaminases. - Pregnancy and nursing. * Precautions: Myopathy / Rhabdomylosis: - Simvastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy, Rhabdomylosis mainfested as muscle pain, tenderness or weakness with creatine kinase (CK) above 10X the upper limit of normal (ULN). - The risk of myopathy / rhabdomylosis is increased by concomitant use of INEGY with the following: Potent inhibitors of CYP3A4, e.g., itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, or nefazodone, particularly with higher doses of INEGY. * Store up to 30 degrees C. Store in the original package in order to protect from moisture and light. * Manufactured by: MSD Technology / Singapore - Singapore. Packed by: Global Napi Pharmaceuticals (GNP) - Egypt. For: MSD - SP Limited - U.K. For: Merck Sharp & Dohme, Haarlem - Netherlands. (Schering-Plough). Trademark (TM) of MSD.