【COMMON NAME】： Simvastatin Tablets

【COMPONENTS】：

The main component is simvastatin , which is chemically known as [1S-[1α,3α,7β,8β(2S*,4S*)8aβ-2,2-Dimethybutanoic acid 1,2,3,7,8,8a - hexahydro - 3,7 - dimethyl - 8 - [2 - (tetrahydro - 4 - hydroxy - 6 - oxo - 2H - pyran - 2 - yl)ethyl] - 1 - naphthalenyl ester.

【 INDICATIONS】：

Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

1.Hyperlipidemia

It is indicated to:

1) Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type Ma, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type Mb). Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia).

2) Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).

3) Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable  

2.Coronary Heart Disease(CHD)

It is indicated to:

1) Reduce the risk of total mortality;

2) Reduce the risk of non-fatal myocardial infarction and stroke;

3) Reduce the need for coronary and non-coronary revascularization procedures

【USAGE AND DOSAGE】

1 Hyperlipidemia

The recommended usual starting dose is 10 mg once a day in the evening meal. For patients with mild to moderate hyperlipidemia, the recommended starting dose is 5 mg/day. Adjustments in dosage should be made in intervals of 4 weeks. The maximum recommended dose is 40 mg/day.

2 CDH

The starting dose is 5 mg/day. Adjustments in dosage should be made in intervals of 4 weeks. The maximum recommended dose is 40 mg/day.

3 Coadministration with other drugs

Simvastatin may be used concomitantly with bile acid sequestrants. If simvastatin is used in combination with cyclosporine, simvastatin should begin with 5 mg/day and should not exceed 10 mg/day. 

4 Renal Dose Adjustments

Because simvastatin does not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal impairment. However, caution should be exercised when simvastatin is administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored.

【SPECIFICATION】： 10mg

【STORAGE】： Sealed, stored in cool place under 20°and kept away from light

【SHELF LIFE】： 2 years