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.

Main ingredients: The main ingredients of this product are: Simvastatin. Molecular formula: C25H38O5 Molecular weight: 418.57

Film-coated tablets appear white or off-white after removing the film coating.

1. Hyperlipidemia (1) For patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia or mixed hypercholesterolemia, when dietary control and other non-drug treatments are not ideal, simvastatin can be used to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B and triglycerides. Simvastatin also increases high-density lipoprotein cholesterol, thereby reducing the ratio of low-density lipoprotein/high-density lipoprotein and total cholesterol/high-density lipoprotein. (2) For patients with homozygous familial hypercholesterolemia, when dietary control and non-dietary treatments are not ideal, simvastatin can be used to reduce elevated total cholesterol, low-density lipoprotein cholesterol and apolipoprotein B. 2. Coronary heart disease. (1) Reduce the risk of death. (2) Reduce the risk of death from coronary heart disease and non-fatal myocardial infarction. (3) Reduce the risk of stroke and transient ischemic attack. (4) Reduce the risk of myocardial revascularization surgery (coronary artery bypass grafting and percutaneous balloon coronary angioplasty). (5) Delay the progression of atherosclerosis, including the occurrence of new lesions and complete blockage.

Oral administration, can be broken up 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, it should be adjusted at an interval of more than four weeks, 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: According to 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 in three doses of 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 method). 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 Collaborative treatment: 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. 5 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 allergic reaction 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. Abnormalities in liver function tests 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 efficacy of simvastatin in patients with heterozygous familial hypercholesterolemia aged 10 to 17 years have been evaluated in a controlled trial conducted in adolescent boys and girls (at least 1 year after menarche). The adverse events of patients treated with simvastatin were generally similar to those in the placebo group. No study was conducted in this population with doses greater than 40 mg. In this limited controlled study, simvastatin was not found to have a significant effect on the growth or sexual maturation of adolescent males or females, or on the length of the menstrual cycle in adolescent females. (See Dosage and Administration, Adverse Reactions, Clinical Trials) It is recommended that adolescent females use appropriate contraceptive methods during simvastatin treatment. (See Contraindications, Precautions, Use in Pregnant and Lactating Women) Simvastatin has not been studied in patients younger than 10 years of age or in girls before menarche. Precautions for pregnancy and lactation: There are no safety data for pregnant women taking simvastatin. No controlled clinical trials of simvastatin have been conducted in pregnant women. There have also been rare reports of birth defects caused by the use of HMG-CoA during pregnancy. However, in a retrospective analysis of approximately 200 patients who had used simvastatin or other closely related HMG-CoA inhibitors during the first trimester of pregnancy, the incidence of birth defects was similar to that of the general population. This number of patients reviewed was statistically sufficient to exclude a birth defect rate that was no more than 2.5 times higher than the normal rate. Although there is no clear evidence that the use of simvastatin by pregnant women increases the incidence of birth defects, simvastatin can reduce fetal mevalonate (a precursor for cholesterol biosynthesis). Atherosclerosis is a chronic process, so stopping lipid-lowering drugs during pregnancy has little effect on the long-term effect of treating primary hypercholesterolemia. Therefore, this product is contraindicated in pregnant women, women who are trying to become pregnant or who may become pregnant. This product should be discontinued during pregnancy (see Contraindications). It is not known whether simvastatin and its metabolites are excreted in human milk. Because many drugs are excreted in human milk and may cause serious adverse reactions, women taking this product should not breastfeed (see Contraindications). Precautions for the elderly: In controlled clinical studies of simvastatin in elderly patients (over 65 years old), its effects on lowering total cholesterol and low-density lipoprotein cholesterol were similar to those in other populations, and the incidence of adverse reactions and laboratory abnormalities did not increase significantly.

1 The risk of rhabdomyolysis is increased when simvastatin is used in combination with other drugs that have a significant inhibitory effect on cytochrome P4503A4 at therapeutic doses (such as cyclosporine, mibefradil, itraconazole, ketoconazole, erythromycin, clarithromycin and nefazodone) or fibric acid derivatives or niacin. 2 The incidence and severity of myopathy are increased when simvastatin is used in combination 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, increased plasma levels of methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitor activity 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, calcium channel blocker mibefradil, itraconazole, ketoconazole and other antifungal azoles, macrolide antibiotics erythromycin and clarithromycin, and 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 concurrently, 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 performed in the same way. 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*14s

36 months