BESTATIN Tablet

Coronary heart disease

In patients with coronary heart disease Simvastatin is indicated to

- Reduce the risk of coronary death and non-fatal myocardial infarction

- Reduce the risk of stroke and transient ischemic attacks (TIA)

Hyperlipidemia

Adjust to diet to reduce elevated total-C, LDL-C, Apo B, and TG and to slightly increase HDL-C in patients with primary hypercholesterolemia, Heterozygous familial hypercholesterolemia or combined (mixed) hyperlipidemia when response to diet and other nonpharmacological measures is inadequate. Simvastatin therefore, lowers the LDL-C/HDL-C and the total-C/HDL-C ratios.

Dosage and Administration

1. Coronary heart disease: Starting dose of 10-20mg/day given as a single dose in the evening.

2. Hyperlipidemia: Starting dose is 10mg/day given as a single dose in the evening. Adjustments of dosage if required should be made at intervals of not less than 4 weeks to maximum of 80mg/day.

3. Concomitant Therapy: Maybe combined with bile acid sequestrants.

1. Hypersensitivity to any component of this preparation

2. Active liver disease or unexplained persistent elevations of serum transaminases

3. No combination with mibefradil

4. Pregnancy nursing women and children

Abdominal pain, constipation and flatulence. Asthenia and headache, myopathy, nausea, diarrhea, rash, dyspepsia, pruritus, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting and anemia. Rarely, rhabdomyolysis and hepatitis/jaundice angioedema, lupus - like syndrome, polymyalgia, rheumatics, vasculitis, thrombocytopenia, eosinophilia, ESR increased, arthritis, arthralgia photosensitivity, fever flushing, dyspnea and malaise.

The risk of rhabdomyolysis is increased by the concomitant use of Simvastatin drugs that have a significant inhibitory effect on CYP450 3A4 at the therapeutic doses (e.g. cyclosporins, mibefradil, itraconazole, ketoconazole, erythromycin and nefazodone) or with fibric acid derivatives or niacin. Simvastatin potentiated the effect of anticoagulants like warfarin.

Nor recommended

See the package insert about the details below:

1. Muscle effects

2. Hepatic effect

Simvastatin is lipid-lowering agents. Reduces elevated total Cholesterol, LDL cholesterol, marked responses are seen within 2 weeks and maximum. Therapeutic responses occur within 4-6 weeks. The response is maintained during continuation of therapy.