Simvastatin Tablets

Product Description

COMPOSITION:

Each film coated tablet contains:

Simvastatin BP .......... 20 mg

Excipients ..................... q.s.

Colour: Red Oxide of Iron & Titanium dioxide BP

INDICATION:

DEVSTAT 20 is indicated: -

For treatment of primary hypercholesterolaemia or mixed dyslipidaemia,as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g., exercise, weight reduction) isinadequate.

For treatment of homozygous familial hypercholesterolaemia (HoFH)as an adjunct to diet and other lipid-lowering treatments (e.g., LDL-apheresis) or if such treatments are not appropriate.

Reduction of cardiovascular mortality and morbidity in patients withmanifest atherosclerotic cardiovascular disease or diabetes mellitus,with either normal or increased cholesterol levels, as an adjunct tocorrection of other risk factors and other cardioprotective therapy.

WARNING AND PRECAUTION:

The risk of myopathy is greater in patients on simvastatin 80 mg comparedwith other statin-based therapies with similar LDL-C-lowering efficacy.

Therefore, the 80-mg dose of Simvastatin should only be used in patientswith severe hypercholesterolemia and at high risk for cardiovascularcomplications who have not achieved their treatment goals on lower doses and when the benefits are expected to outweigh the potential risks.

All patients starting therapy with simvastatin, or whose dose of simvastatinis being increased, should be advised of the risk of myopathy and told toreport promptly any unexplained muscle pain, tenderness or weakness.

A higher rate of myopathy has been observed in patients titrated to the80mg dose.

Therapy with simvastatin should be temporarily stopped a few days prior toelective major surgery and when any major medical or surgical conditionsupervenes.

The dose of simvastatin should not exceed 20 mg daily in patientsreceiving.

SIDE EFFECTS:

Gastro-intestinal disturbances such as abdominal pain, constipation, and flatulence may occur. Other side-effects include asthenia, headache, nausea, diarrhoea, skin rashes, dyspepsia, pruritus, anaemia, fatigue, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paraesthesia, vomiting, blurred vision, insomnia, peripheral neuropathy.

PRESENTATION:

10 x 10 Tablets in printed carton along with pack insert.