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

This product is white or off-white tablets.

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. 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.

Oral administration, can be broken up and taken if necessary. 1. Hypercholesterolemia: The general initial dose is 10 mg per day (5 mg specification: 2 tablets; 10 mg specification: 1 tablet), taken at night. For patients with mild to moderate cholesterol levels, the initial dose is 5 mg per day (5 mg specification: 1 tablet; 10 mg specification: half a tablet). If the dose needs to be adjusted, it should be adjusted at intervals of more than four weeks. The maximum dose is 40 mg per day (5 mg specification: 8 tablets; 10 mg specification: 4 tablets), taken at night. 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 simvastatin 40 mg/d 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 (5 mg specification: 4 tablets; 10 mg specification: 2 tablets) every night as the starting dose. If dose adjustment is required, please refer to the above instructions (Usage and Dosage for Hypercholesterolemia). 4. Collaborative 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 mg specification: 2 tablets; 10 mg specification: 1 tablet). 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 < 30 ml/min), if the dose exceeds 10 mg per day (5 mg specification: 2 tablets; 10 mg specification: 1 tablet), 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 were mild or transient. Elevations in serum creatine phosphokinase (CK), which is derived from skeletal muscle, have also been reported.

1. Those who are allergic to any component of this product; 2. Those with active hepatitis or unexplained persistent elevation of serum transaminase; 3. Pregnant or lactating women; 4. Use with caution in elderly patients.

Precautions for children: The safety and effectiveness of simvastatin for children have not been determined. Simvastatin is not currently recommended for children. Precautions for pregnancy and lactation: Contraindicated for pregnant women. Precautions for the elderly: Use with caution in elderly patients.

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 nicotinic acid, 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 nicotinic acid (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, 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 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 55℃.

5mg

36 months.

PKU HealthCare Corp., Ltd.

• Founded in:

  1993-05-18

• Address:

  No. 21, Fangzheng Avenue, Shuitu Town, Beibei District, Chongqing

• Tax NO.:

  91500000450533779H

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  595.987425 yuan

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