Simvastatin Tablets

This product itself is inactive. The hydrolysis product after oral absorption competitively inhibits the rate-limiting enzyme hydroxymethylglutaryl coenzyme A reductase in the cholesterol synthesis process in the body, reducing the synthesis of cholesterol and increasing the synthesis of low-density lipoprotein receptors. The main site of action is in the liver, resulting in lower blood cholesterol and low-density lipoprotein cholesterol levels, moderately lower serum triglyceride levels and increased blood high-density lipoprotein levels. This has an effect on the prevention and treatment of atherosclerosis and coronary heart disease. In mice, 3 to 4 times the human dose can cause cancer, but no increase in tumor occurrence has been observed in large-scale long-term clinical trials in humans. Existing studies have not found that this product has a mutagenic effect.

The main ingredient of this product is simvastatin. Its chemical name is 2,2-dimethylbutyric acid-8-[(4R,6R)-6-2-[(1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl]ethyltetrahydro-4-hydroxy-2H-pyran-2-one] ester. Its molecular formula is C25H38O5 and its molecular weight is 418.57.

Film-coated tablets: the core of the tablet after removing the film coating is white or off-white.

1. When dietary therapy and other non-drug treatments for hypercholesterolemia are ineffective, simvastatin can be used to reduce total cholesterol and low-density lipoprotein cholesterol in patients with primary hypercholesterolemia. Simvastatin can also increase high-density lipoprotein cholesterol and thus reduce the ratio of low-density lipoprotein cholesterol/high-density lipoprotein cholesterol and total cholesterol/high-density lipoprotein cholesterol. In patients with combined hypercholesterolemia and hypertriglyceridemia, when hypercholesterolemia is the main abnormality, it can reduce elevated cholesterol levels. 2. Coronary heart disease For patients with coronary heart disease, simvastatin is suitable for: reducing the risk of death; reducing the risk of death from coronary heart disease and non-fatal myocardial infarction; reducing myocardial revascularization surgery (coronary artery bypass grafting and percutaneous balloon coronary angioplasty); delaying the progression of atherosclerosis, including the occurrence of new lesions and total blockage.

1 Oral administration: If necessary, the tablets can be broken and taken. (1) Hypercholesterolemia: The general initial dose is 10 mg per day, taken in the evening. For patients with mild to moderate cholesterol levels, the initial dose is 5 mg per day. If the dose needs to be adjusted, it should be adjusted at an interval of more than four weeks. 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 that simvastatin 40 mg/d be taken in the evening, or 80 mg/d be taken three times: 20 mg in the morning, 20 mg at noon, and 40 mg in the evening. Simvastatin should be used in combination with other lipid-lowering therapies (such as low-density lipoprotein extraction). When these methods cannot be used, simvastatin can also be used alone. (3) Coronary heart disease: Patients with coronary heart disease can take 20 mg every night as a starting dose. If dose adjustment is required, please refer to the above instructions (Usage and Dosage for Hypercholesterolemia (4) Concomitant therapy: Simvastatin is effective when used alone or in combination with bile acid chelators. For patients who are taking immunosuppressants at the same time, the recommended dose of simvastatin is 10 mg per day. 2 Renal insufficiency: Since simvastatin is not significantly excreted by the kidneys, patients with moderate renal insufficiency do not need to adjust the dose; for patients with severe renal insufficiency (creatinine clearance less than 30 ml/min), if the dose exceeds 10 mg per day, it should be carefully considered and used with caution.

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 a drug-related incidence greater than or equal to 1% include: abdominal pain, constipation, and flatulence. 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 appeared in uncontrolled clinical trials or post-marketing applications, such as nausea, diarrhea, rash, dyspepsia, itching, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting and anemia, rhabdomyolysis and hepatitis/jaundice rarely occur. Rarely, there have been reports of apparent hypersensitivity syndromes including one or more of the following features, such as angioedema, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate (ESR), arthritis, arthralgia, urticaria, photosensitivity, fever, flushing, dyspnea, and malaise. Laboratory findings: Rarely, significant and persistent elevations of serum aminotransferases have been reported. Liver function test abnormalities are mild or transient. Elevations in serum creatine phosphokinase (CK), which is derived from skeletal muscle, have also been reported.

1. Patients who are allergic to any ingredient. 2. Patients with active hepatitis or unexplained persistent elevation of serum aminotransferase. 3. Patients who are used in combination with tetralin calcium channel blocker mibefradil.

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 cholesterol biosynthetic pathways. 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 of the possible damage. 2. It is not known whether simvastatin and its metabolites are secreted in human milk. Because many drugs are secreted in human milk and have potential serious side effects, women taking simvastatin should not breastfeed. Elderly precautions: In controlled clinical trials of simvastatin in elderly patients (over 65 years old), its effect on lowering total cholesterol and low-density lipoprotein (LDL) cholesterol was the same as that of 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 P450 3A4 at therapeutic doses (such as cyclosporine, mibefradil, itraconazole, ketoconazole, erythromycin, clarithromycin and nefazodone) or fibric acid derivatives or niacin, the risk of rhabdomyolysis is increased. 2. The incidence and severity of myopathy are increased by the combination of this product with methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitors, including gemfibrozil and other fibrates, and 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 are metabolized by the cytochrome P450 isoenzyme 3A4. Several drugs that have a significant inhibitory effect on this metabolic pathway at therapeutic doses can increase the blood levels of methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitors and thus increase the risk of myopathy. These drugs include cyclosporine, tetralins, the calcium channel blocker mibefradil, itraconazole, ketoconazole and other antifungal azoles, the macrolide antibiotics erythromycin and clarithromycin, and the antidepressant nefazodone. 3 Coumarin derivatives: Clinical studies have found that simvastatin can moderately enhance the anticoagulant effect of coumarin anticoagulants. Therefore, when adults use anticoagulant therapy in the early stage and use simvastatin concomitantly, the prothrombin time should be checked multiple times to ensure that the prothrombin time has not changed significantly. When patients taking coumarin derivatives have a stable prothrombin time, it is still recommended to continue monitoring the prothrombin time for a fixed period of time. If the dose of simvastatin is changed, the above procedure should be followed. In patients not taking anticoagulants, simvastatin therapy has not been reported to affect bleeding or prothrombin time.

Keep sealed and below 30℃. Avoid instantaneous temperature exceeding 50℃.

20mg

36 months.

Han Hui Pharmaceuticals Company Limited

• Founded in:

  2012-09-06

• Address:

  No. 2 Haizheng Road, Xukou Town, Fuyang District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100053653670B

• Registered Funds:

  1852.03035908 yuan

• Website:

  Log in to view

• Email:

  Log in to view