Simvastatin

Indications
 Oral
Hyperlipidaemias
Adult: Initially, 10-20 mg/day, to be taken in the evening. May start with 40 mg once daily in patients with high CV risk or require a large reduction in cholesterol. For patients with moderate CV risk, initiate with 10 mg once daily. May adjust dose at intervals of at least 4 wk. Max: 80 mg once daily. For patients with homozygous familial hypercholesterolaemia: 40 mg once daily in the evening or 80 mg daily (given in 3 divided doses of 20 mg, 20 mg and an evening dose of 40 mg).
Renal impairment: Severe impairment: initially, 5 mg once daily with close monitoring.
Oral
Cardiovascular risk reduction
Adult: In high-risk patients (e.g. patients with DM or atherosclerotic cardiovascular disease): 20-40 mg once daily. Moderate-risk patients: 10 mg once daily.
Renal impairment: Severe impairment: initially, 5 mg once daily with close monitoring.
Contraindications
 Acute liver disease or unexplained persistent elevations of serum transaminases. Pregnancy, lactation. Porphyria. Patients of Chinese descent should not take 80 mg dose w/ lipid-modifying dose of niacin-containing products (≥1 g/day).
Warnings / Precautions
 History of liver disease. Increased risk of rhabdomyolysis in severe infection, hypotension, major surgical trauma, uncontrolled seizures or severe metabolic, endocrine and electrolyte disorder. Alcoholism; premenarcheal females; children <10 yr. Discontinue treatment if there is marked or persistent increase in serum-aminotransferase concentrations.
Adverse Reactions
 Headache, nausea, flatulence, heartburn, abdominal pain, diarrhoea/constipation, dysgeusia; dose-related myopathy (e.g. myalgia, muscle weakness and dark urine); serum transaminases and CPK elevations; hypersensitivity; lens opacities; blurring of vision; dizziness; sexual dysfunction; insomnia; depression and upper respiratory symptoms.
Potentially Fatal: Severe rhabdomyolysis with acute renal failure.
Drug Interactions
 May cause slight elevation of serum digoxin. May increase risk of bleeding when used with coumarins and fluindione. Serum levels may be increased when used with ranolazine, verapamil, diltiazem and imatinib. Reduced serum levels when used with carbamazepine and rifampicin. Increased risk of myopathy when used with ciclosporin, colchicine, danazol and gemfibrozil.
Potentially Fatal: Concurrent use with amiodarone, itraconazole, ketoconazole, clarithromysin, erythromycin, telithromycin, nefazodone, niacin or protease inhibitors may increase the risk of rhabdomyolysis and acute renal failure.
See Below for More simvastatin Drug Interactions
Food Interactions
 Concurrent admin with large amounts of grapefruit juice may increase serum levels of simvastatin. Serum levels may be reduced by St John's wort.
Mechanism of Actions
 Simvastatin is a prodrug metabolised in the liver to form the active β-hydroxyacid derivative. This inhibits the conversion of HMG-CoA to mevalonic acid by blocking HMG-CoA reductase, an early and rate-limiting step in cholesterol biosynthesis. It reduces total cholesterol, LDL-cholesterol and triglycerides and increases HDL-cholesterol levels.
Onset: 3 days.
Absorption: Absorbed from the GI tract (oral).
Distribution: Protein-binding: 95%.
Metabolism: Extensively hepatic; undergoes metabolism by CYP3A4.
Excretion: Mainly excreted in the faeces as metabolites. Urine (10-15% inactive form); 1.9 hr (elimination half-life, active metabolite).
Administration
 May be taken with or without food. (Avoid excessive consumption (>1 L/day) of grapefruit juice.)
Storage Conditions
 Oral: Store at 5-30°C.
ATC Classification
 C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Storage
 Oral: Store at 5-30°C.
Available As
  • Simvastatin 10 mg
  • Simvastatin 20 mg
  • Simvastatin 40 mg
  • Simvastatin 5 mg

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