ADP Pharma


Metro Drug


Seville Pharma
Full Prescribing Info
Each film-coated tablet contains: Simvastatin 20 mg or 40 mg.
Pharmacology: Pharmacokinetics: Simvastatin is absorbed from the gastrointestinal tract and is hydrolysed to its active β-hydroxy acid form. Other active metabolites have been detected and a number of inactive metabolites are also formed. It undergoes extensive first-pass metabolism in the liver, its primary site of action. Less than 5% of the oral dose has been reported to reach the circulation as active metabolites. Both simvastatin and its β-hydroxy acid metabolite are about 95% bound to plasma proteins. It is mainly excreted in the faeces via the bile as metabolites. About 10 to 15% is recovered in the urine, mainly in inactive forms. The half-life of the active metabolite is 1.9 hours.
Simvastatin is a lipid regulating drug. It is used to reduce LDL cholesterol, apolipoprotein B, and triglycerides, and to increase HDL cholesterol in the treatment of hyperlipidaemias, including hypercholesterolaemias and combined (mixed) hyperlipidaemia (type IIa or IIb hyperlipoproteinaemias). Statins can be effective as adjunct therapy in patients with homozygous familial hypercholesterolaemia who have some LDL-receptor function. Simvastatin is also given prophylactically to hypercholesterolaemic patients with ischemic heart disease.
Dosage/Direction for Use
Simvastatin is given by mouth in an initial dose of 5 to 10 mg in the evening; an initial dose of 20 mg may be used in patients with ischaemic heart disease. The dose may be adjusted at intervals of not less than 4 weeks up to a maximum of 80 mg once daily in the evening. Patients with homozygous familial hypercholesterolaemia may be treated with 40 mg once daily in the evening, or 80 mg daily in three divided doses of 20 mg, 20 mg, and an evening dose of 40 mg. A maximum of 10 mg daily is recommended in those taking cyclosporine, fibric acid derivatives, or nicotinic acid, and the risk of myopathy must be considered. Or as prescribed by the physician.
Special Precautions
Simvastatin should not be given to patients with acute liver disease or unexplained persistently raised serum-aminotransferase concentrations. It should be avoided during pregnancy since there is a possibility that it could interfere with fetal sterol synthesis; there have been a few reports of congenital abnormalities associated with statins. It should be discontinued if marked or persistent increases in serum aminotransferase or creatine phosphokinase concentrations occur. It should be used with caution in patients with severe renal impairment.
Adverse Reactions
The most common adverse effects of therapy with simvastatin and other statins are gastrointestinal disturbances. Other adverse effects reported include headache, skin rashes, dizziness, blurred vision, insomnia and dysgeusia.
Drug Interactions
There is increased risk of myopathy if certain drugs are given concurrently with statins.
Store at temperatures not exceeding 30°C.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
FC tab 20 mg x 30's. 40 mg x 30's.
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