Sivatin 20mg, 40mg

FORMULATION:
Each film-coated tablet contains:
Simvastatin………………………. 20 mg
Simvastatin………………………. 40 mg

PHARMACOKINETICS:
Simvastatin is absorbed from the gastrointestinal tract and is hydrolysed to its active B-hydroxyacid 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 B-hydroxyacid 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.

INDICATIONS:
Simvastatin is a lipid regulating drug. It is used to reduce LDL-cholesterol and triglycerides, and to increase HDL-cholesterol in the treatment of hyperlipidaemias, including hypercholesterolaemias and combined hyperlipidaemia. Simvastatin is also given prophylactically to hypercholesterolaemic patients with ischemic heart disease.

DRUG INTERACTION:
There is increased risk of myopathy if certain drugs such as immuniosuppressants, fibric acid derivatives, or nicotinic acid are given concurrently with statins.

ADVERSE EFFECTS:
The commonest adverse effects of therapy with simvastatin and other statins are gastrointestinal disturbances. Other adverse effects include headache, skin rashes, dizziness, blurred vision, insomnia and dysgeusia.

PRECAUTION:
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 increase in serum-aminotransferarase or creatine phosphokinase occur. It should be used with caution in patients with severe renal impairment.

DOSAGE AND ADMINISTRATION:
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.
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.
Or as prescribed by the physician.

AVAILABILITY:
Simvastatin 20 mg FC Tablet (Sivatin) Pack in blister foil X 10’s (Box of 100’s)
Simvastatin 40 mg FC Tablet (Sivatin) Pack in blister foil X 10’s (Box of 50’s)

CAUTION:
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

STORE AT TEMPERATURES NOT EXCEEDING 30° C.

Manufactured by:
Stallion Laboratories Pvt. Ltd.
CIB, 305, 2&3 GIDC, Kerala (Bavla)
Dist.: Ahmedabad, India

Imported by:
Suhitas Pharmaceuticals Inc.
3rd Floor. Centerpoint Bldg., Pasong Tamo
Cor. Export Bank Drive, Makati City

Distributed & Marketed by:
PharmacoExcellence, Inc.
701 B Park Trade Center Bldg.,
Madrigal Corporate Center,
Alabang, Muntinlupa City

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