Product Overview
[Drug Name]
Generic Name: Simvastatin Tablets
Trade Name: Ginadol Simvastatin Tablets 20mg x 36 Tablets
[Main Ingredient]
The main ingredient of this product is simvastatin. Chemical Name: 2,2-Dimethylbutanoic acid-8-[(4R,6R)-6-[2-[(1S,2S,6R,8S,8αR)-1,2,6,7,8,8α-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl]ethyl]tetrahydro-4-hydroxy-2H-pyran-2-one-8-ester. Molecular Formula: C25H38O5 Molecular Weight: 418.57
[Properties]
This product is a white or off-white tablet.
[Indications/Main Functions]
Simvastatin can be used to treat primary hypercholesterolemia in patients with unsatisfactory dietary control and other non-drug treatments. Simvastatin not only lowers total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, but also increases high-density lipoprotein cholesterol, thereby reducing the LDL-to-HDL cholesterol and total-to-HDL cholesterol ratios. In patients with coexisting hypercholesterolemia and hypertriglyceridemia, where hypercholesterolemia is predominant, simvastatin can lower cholesterol levels. For patients with coronary artery disease and hypercholesterolemia, simvastatin is indicated for: - reducing the risk of death; - reducing the risk of coronary artery death and nonfatal myocardial infarction; - reducing the need for myocardial revascularization procedures (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty) due to coronary events; - slowing the progression of coronary atherosclerosis, including reducing the formation of new lesions and complete blockages.
[Specifications]
20mg x 36 tablets
[Dosage and Administration]
For oral use, patients should follow a standard cholesterol-lowering diet before starting simvastatin therapy and continue to do so during treatment. 1. Hypercholesterolemia: The general starting dose is 10 mg (1/2 tablet) per day, taken in the evening. For patients with mild to moderately elevated cholesterol levels, the starting dose is 5 mg (1/4 tablet) per day. Dose adjustments should be made at least four weeks apart, with a maximum dose of 40 mg (2 tablets) per day, taken in the evening. Cholesterol levels should be monitored regularly, and if cholesterol levels are significantly below the target range, a dose reduction of simvastatin should be considered. 2. Coronary Artery Disease: Patients with coronary artery disease can start with 20 mg (1 tablet) per day. Dose adjustments should be made at least four weeks apart, with a maximum dose of 40 mg (2 tablets) per day, taken in the evening. 3. Concomitant Medication: Simvastatin is effective both alone and in combination with bile acid sequestrants. Concomitant use with fibrates or niacin should generally be avoided. For patients taking immunosuppressants (such as cyclosporine), the starting dose of simvastatin should be 5 mg (1/4 tablet) per day, not to exceed 10 mg (1/2 tablet) per day. 4. Patients with Renal Impairment: Since simvastatin is primarily excreted via bile and only minimally via the kidneys, no dosage adjustment is required for patients with moderate renal impairment. However, this product should be used with caution in patients with severe renal impairment (creatinine clearance <30 ml/min). The starting dose for such patients should be 5 mg (1/4 tablet)/day. Close monitoring is recommended when the dose exceeds 10 mg (1/2 tablet)/day.
[Adverse Reactions]
See package insert for details.
[Contraindications]
See package insert for details.
[Precautions]
See package insert for details.
