Each tablet contains: Simvastatin 20 mg.
Pharmacology: Pharmacokinetics: Simvastatin is readily absorbed from the gastro-intestinal tract after oral administration. It is then hydrolysed to its active form, β-hydroxyacid, and metabolites (active and inactive). Less than 5% of Simvastatin goes to circulation as active metabolites, and about 95% of it and its active form are bound to plasma proteins. Primary means of excretion is thru the feces (as metabolites) and about 10-15% is eliminated in the urine as the inactive form.
Used to reduce low-density lipoprotein-cholesterol, apolipoprotein B and triglycerides, and to increase high-density cholesterol in the treatment of hyperlipidaemias. Also used as adjunct treatment in patient with homozygous familial hypercholesterolaemia, and is given prophylactically to hypercholesterolaemic patients with ischaemic heart disease.
For patients with ischaemic heart disease: Adults: Initial dose of 20 mg in the evening. Dosage may be adjusted at intervals of not less than 4 weeks up to a maximum of 80 mg once daily in the evening.
For patients with homozygous familial hypercholesterolaemia: Adults: 40 mg once daily in the evening or 80 mg daily in three divided doses: 20 mg, 20 mg and 40 mg in the evening.
For patients taking ciclosporin, fibric acid derivatives or nicotinic acid: Adults: Maximum dose of 10 mg daily.
Or as prescribed by a physician.
Simvastatin should not be given to patients hypersensitive to it and to those with acute liver disease or unexplained persistently raised serum-aminotransferase concentrations. Use during pregnancy is not recommended.
Discontinue therapy if marked or persistent increases in serum-aminotransferase or creatinine phosphokinase concentrations occur.
Liver function should be assessed prior to initial treatment and should be monitored periodically until one year after the last dosage increment. Simvastatin must be used with caution in patients with severe renal impairment.
Use during pregnancy is not recommended.
The most common adverse effects of Simvastatin are gastro-intestinal disturbances. Others include headache, skin rashes, dizziness, blurred vision, insomnia and dysguesia. Hypersensitivity syndrome (manifested by angioedema), hepatitis and pancreatitis have also been reported. Rarely, rhabdomyolysis with acute renal failure may develop.
Ciclosporin, Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, HIV-Protease Inhibitors and Nefazodone: If given concomitantly with Simvastatin, these drugs increase the risk of myopathy.
Fibric acid derivatives and Nicotinic Acid: These drugs further increase the risk of myopathy if given with Simvastatin.
Coumarin anticoagulants: Concurrent administration of these drugs with Simvastatin may cause bleeding and increases in prothrombin time.
Mibefradil: This drug is reported to increase concentration of Simvastatin.
Store at temperatures not exceeding 30°C.
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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