Product Overview
[Drug Name]
Generic Name: Simvastatin Capsules
Trade Name: Lishuda Simvastatin Capsules 20mg x 20 capsules
[Main Ingredient]
Simvastatin.
[Properties]
This product consists of white or off-white granules or powder.
[Indications/Main Functions]
For the treatment of hypercholesterolemia and combined hyperlipidemia; prevention and treatment of coronary heart disease and stroke.
[Specifications]
20mg x 20 capsules
[Dosage and Administration]
Usual adult oral dose: 10-20mg once daily, taken with dinner. The dose can be adjusted as needed, but the maximum daily dose should not exceed 80mg.
[Adverse Reactions]
1. The most common adverse reaction to this product is gastrointestinal discomfort. Others include headache, rash, dizziness, blurred vision, and taste disturbances. 2. It may occasionally cause a reversible increase in serum aminotransferase levels. Therefore, liver function should be monitored. 3. Rare adverse reactions include impotence and insomnia. 4. Rare adverse reactions include myositis, myalgia, and rhabdomyolysis, manifested as muscle pain, fatigue, fever, and accompanied by elevated blood creatine phosphokinase and myoglobinuria. Rhabdomyolysis can lead to renal failure, but this is rare. Concomitant use of this product with immunosuppressants, folic acid biologics, niacin, gemfibrozil, and erythromycin may increase the risk of myopathy. 5. Hepatitis, pancreatitis, and allergic reactions such as angioedema have been reported.
[Contraindications]
1. Contraindicated in patients allergic to simvastatin. Use with caution in patients allergic to other HMG-CoA reductase inhibitors. 2. Contraindicated in patients with active liver disease or persistently elevated blood aminotransferases of unexplained origin.
[Drug Interactions]
1. Concomitant use of this product with oral anticoagulants may prolong the prothrombin time and increase the risk of bleeding. 2. Concomitant use of this product with immunosuppressants such as cyclosporine, erythromycin, gemfibrozil, and niacin may increase the risk of myolysis and acute renal failure. 3. Colestipol and cholestyramine may reduce the bioavailability of this drug; therefore, this drug should be taken 4 hours after the former.
[Precautions]
1. Regularly check blood cholesterol and creatine phosphokinase levels during treatment. Blood aminotransferases may increase with this drug. Patients with a history of liver disease should also have their liver function tests monitored regularly. 2. During treatment with this drug, if blood aminotransferases increase by up to three times the upper limit of normal, or if blood creatine phosphokinase increases significantly, or if symptoms of myositis or pancreatitis occur, this drug should be discontinued. 3. When using this drug in the presence of hypotension, severe acute infection, trauma, or metabolic disturbances, be aware of the potential for renal failure secondary to myolysis. 4. The dose of this drug does not need to be reduced in moderate renal impairment, but in severe renal impairment (creatinine clearance <30 ml/min), the dose should be reduced and used with caution. 5. This drug should be taken with food to enhance absorption. 6. Dietary therapy remains the primary treatment for hyperlipidemia. Combined with exercise and weight loss, it is superior to any other medication. Please read the instructions carefully and use as directed by your doctor.
[Pediatric Use]
Use in children is limited, and long-term safety has not been established.
[Elderly Use]
Dose adjustment is required for elderly patients based on liver and kidney function.
[Overdose]
Unknown.
[Pharmacology and Toxicology]
This drug is inactive. After oral administration, its hydrolysis product competitively inhibits hydroxymethylglutaryl-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, reducing cholesterol synthesis and increasing low-density lipoprotein receptor synthesis. The primary site of action is in the liver, resulting in lower blood cholesterol and LDL cholesterol levels, moderately lowering serum triglyceride levels, and increasing high-density lipoprotein levels. This may have a preventive and therapeutic effect on atherosclerosis and coronary heart disease. In mice, it can be carcinogenic at doses 3-4 times the human dose. However, no increase in tumor development has been observed in large-scale, long-term clinical trials in humans. Existing studies have not found that this product has mutagenic effects.
