Simvastatin Tablets

This product is a methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitor, which inhibits the synthesis of endogenous cholesterol and is a blood lipid regulator. Literature data show that it can reduce the cholesterol (TC) content in the serum, liver, and aorta of hyperlipidemia rabbits, and reduce the levels of very low density lipoprotein cholesterol (VLDL-C) and low density lipoprotein cholesterol (LDL-C).

The main ingredients and their chemical names are: Simvastatin, [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 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. For patients with coronary heart disease, simvastatin is used to: (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.

1. 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 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, it is recommended that patients with homozygous familial hypercholesterolemia 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). 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. (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 an incidence greater than or equal to 1% related to the drug 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 occurred in uncontrolled clinical trials or post-marketing applications, such as nausea, diarrhea, rash, dyspepsia, itching, hair loss, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting, and anemia.

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

Precautions for children: The safety and effectiveness of the drug for children have not yet 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, discontinuation of lipid-lowering drugs during pregnancy has little effect on the long-term effects 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 harm 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 her of the possible harm to the fetus. 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 P4503A4 at therapeutic doses (such as cyclosporine, mibefradil, 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, high levels of increased activity of methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitors in plasma will also increase the risk of myopathy. Simvastatin and its

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

5 mg

36 months.