Simvastatin Tablets

Simvastatin. Chemical name: [1S-[1a, 3a, 7b (2S*, 4S*) 8ab]]-1,2., 3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthyl-2,2-dimethylbutyrate. Molecular weight: C25H38O5

This product is a film-coated tablet; the tablet core after removing the film coating is white or off-white.

Oral administration: The tablets can be broken and taken if necessary. (1) Hypercholesterolemia: The general initial dose is 10 mg per day, taken in the evening. For patients with mild to moderately elevated cholesterol levels, the initial dose is 5 mg per day. If the dose needs to be adjusted, an interval of more than four weeks should be maintained, and the maximum dose is 40 mg per day, taken in the evening. When the low-density lipoprotein cholesterol level drops to 75 mg/dL (1.94 mmol/L) or the total cholesterol level drops to below 140 mg/dL (3.6 mmol/L), the dose of simvastatin should be reduced. (2) Homozygous familial hypercholesterolemia: Based on the results of controlled clinical studies, for patients with homozygous familial hypercholesterolemia, it is recommended to take 40 mg/d of simvastatin in the evening, or 80 mg/d, divided into 20 mg in the morning and 20 mg in the afternoon.

Simvastatin is generally well tolerated, and most adverse reactions are mild and transient. In controlled clinical trials, less than 2% of patients discontinued simvastatin due to adverse reactions. In clinical trials with control groups, adverse reactions (classified as possible, suspected or certain) with an incidence greater than or equal to 1% of drug-related reactions include: abdominal pain, constipation, gastrointestinal bloating, and adverse reactions with an incidence of 0.5% to 0.9% include fatigue, weakness, and headache. Reports of myopathy are rare. Reports of the following adverse reactions have occurred in uncontrolled clinical trials or marketed applications. Itching and anemia are rarely reported. Rhabdomyolysis and hepatitis have been reported. Jaundice has been reported rarely. Obvious allergic reaction syndromes including one or more of the following features: angioedema, lupus-like syndrome, polymyalgia rheumatica,

1. Those who are allergic to any ingredient of this product; 2. Those with active hepatitis or unexplained persistent elevation of serum transaminase; 3. Pregnant or lactating women.

Precautions for children: The safety and effectiveness of the drug for children have not been determined. Simvastatin is not currently recommended for children. Precautions for pregnancy and lactation: 1. There is no data on the use of simvastatin by pregnant women. Simvastatin is contraindicated for pregnant women. Because atherosclerosis is a chronic process, stopping simvastatin tablets and lipid-lowering drugs during pregnancy has little effect on the long-term effect of treating primary hypercholesterolemia. Moreover, cholesterol and other products of its biosynthetic pathway are essential components for fetal development, including the synthesis of steroids and cell membranes. Because methylhydroxyglutaryl coenzyme A (HMG-CoA) reductase inhibitors such as simvastatin can reduce cholesterol synthesis, and can also reduce other products of the cholesterol biosynthetic pathway. Therefore, pregnant women taking simvastatin may be harmful to the fetus. Among women of childbearing age, simvastatin can only be used for those women who are unlikely to become pregnant. If a woman becomes pregnant while taking the drug, she should stop taking simvastatin and inform the fetus. Precautions for the elderly: In controlled clinical trials of simvastatin in elderly patients (over 65 years old), its effects on lowering total cholesterol and low-density lipoprotein (LDL) cholesterol were the same as those in other populations, and the frequency of adverse reactions and laboratory test abnormalities did not increase significantly.

1. When simvastatin is used in combination with other drugs that have a significant inhibitory effect on cytochrome P4503A4 at therapeutic doses (such as cyclosporine, mibedesimvastatin tablets, itraconazole, ketoconazole, erythromycin, clarithromycin and nefazodone) or fibric acid derivatives or niacin, the risk of rhabdomyolysis increases. 2. The combined use of this product with methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitors will increase the incidence and severity of myopathy. These drugs include gemfibrozil and other fibrates, as well as lipid-lowering doses of niacin (greater than or equal to 1g/d). In addition, the increased activity of high levels of methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitors in plasma will also increase the risk of myopathy. Simvastatin and other methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitors

Keep in a dark and closed place in a cool place.

40mg*7s

36 months

Beijing Foyou Pharma Co., Ltd.

• Founded in:

  1999-02-03

• Address:

  No. 8 Guangyuan East Street, Tongzhou Industrial Development Zone, Tongzhou District, Beijing

• Tax NO.:

  91110112700216160K

• Registered Funds:

  480 million yuan

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