Corstat

Corstat

simvastatin

Manufacturer:

Medreich

Distributor:

The Glory Medicina
/
DKSH
Concise Prescribing Info
Contents
Simvastatin
Indications/Uses
In CHD: Reduce risk of mortality in CHD; reduce risk of coronary death and nonfatal MI; reduce risk for undergoing myocardial revascularisation procedures; slow progression of coronary atherosclerosis including reduction in the development of new lesions & new total occlusions. In hyperlipidemia: Adjunct to diet for the reduction of elevated total-cholesterol, LDL-cholesterol, apolipoprotein B & triglycerides in patients w/ primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidemia, when response to diet & other nonpharmacological measures is inadequate. In homozygous familial hypercholesterolaemia: Adjunct to diet & other nondietary measures in reducing elevated total-cholesterol, LDL-cholesterol & apolipoprotein B in patients w/ homozygous familial hypercholesterolaemia when response to these measures is inadequate.
Dosage/Direction for Use
CHD Initially 20 mg/day as a single dose in the evening. Adjust dosage at 4-wk intervals to a max of 80 mg/day as a single dose in the evening. Hyperlipidaemia 10 mg once daily in the evening. Homozygous familial hypercholesterolaemia 40 mg/day as a single dose in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg & a 40 mg dose in the evening. Concomitant therapy In patients taking cyclosporin, fibrates or niacin concomitantly max: 10 mg/day. Severe renal insufficiency (CrCl <30 mL/min) Caution w/ dosage >10 mg/day.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Active liver disease or unexplained persistent elevations of serum transaminases; porphyria. Pregnancy & lactation.
Special Precautions
Risk of myopathy/rhabdomyolysis. Perform liver function tests prior to therapy & periodically thereafter. Patients who consume substantial quantities of alcohol &/or past history of liver disease.
Adverse Reactions
Abdominal pain, constipation, flatulence, asthenia, headache. Rarely, myopathy.
Drug Interactions
Gemfibrozil & other fibrates, lipid-lowering doses (1 g/day) of niacin. CYP3A4 inhibitors eg cyclosporin, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV-protease inhibitors & nefazodone. Grapefruit juice, digoxin, coumarin derivatives.
ATC Classification
C10AA01 - simvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Corstat film-coated tab 10 mg
Packing/Price
2 × 14's
Form
Corstat film-coated tab 20 mg
Packing/Price
2 × 14's
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