Simvastatin Tablets

In two clinical studies, it was found that simvastatin can moderately enhance the anticoagulant effect of bean-scented anticoagulants. Prothrombin time should be checked frequently before early anticoagulant therapy and simvastatin use in adults to determine whether there is a significant change in prothrombin time. When patients taking bean-scented derivatives have a stable prothrombin time, it is recommended to continue monitoring 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 treatment has never been reported to affect bleeding or prothrombin time.

Simvastatin.

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

1. Hypercholesterolemia: When dietary therapy and other non-drug treatments 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.

Patients should follow a standard cholesterol diet before receiving simvastatin treatment and continue to use it during treatment. Hypercholesterolemia: The general starting dose is 10 mg per day, taken in the evening. For patients with mild to moderate cholesterol levels, the starting 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. Coronary heart disease: Patients with coronary heart disease can take 20 mg every night as the starting dose. If the dose needs to be adjusted, refer to the above instructions (Usage and Dosage for Hypercholesterolemia). Concomitant therapy: Simvastatin is effective when used alone or in combination with bile acid chelators. For patients who are already taking immunosuppressants at the same time, the recommended dose of simvastatin is 10 mg per day. Patients with renal insufficiency: Since simvastatin is not significantly excreted by the kidneys, there is no need to adjust the dose for patients with moderate renal insufficiency. For patients with severe renal insufficiency (creatinine clearance < 30ml/min), if the dose exceeds 10mg per day, careful consideration should be given and use should be carried out 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% of drug-related reactions include: abdominal pain, constipation, flatulence, and adverse reactions with an incidence of 0.5% to 0.9% include fatigue and headache. Reports of myopathy are rare. Reports of the following adverse reactions have appeared in clinical trials without control groups or in applications on the market. Itch and anemia Rhabdomyolysis and hepatitis are rarely reported Jaundice Significant allergic reaction syndromes with one or more of the following features are rarely reported: angioedema, lupus-like syndrome, rheumatic polymyalgia, vasculitis, thrombocytopenia, eosinophilia, arthritis, arthralgia, hives, fever, pyrexia, flushing, difficulty breathing, and discomfort. Laboratory findings: Significant and persistent elevations in serum transaminases are rarely reported. Liver function test abnormalities are mild or transient. Elevations in serum creatine kinase (CK), derived from skeletal muscle, have been reported.

Patients who are allergic to any component of this product; patients with active hepatitis or unexplained persistent elevation of serum transaminases; pregnant or lactating women.

Precautions for children: The safety and effectiveness of simvastatin for children have not been established. Simvastatin is not currently recommended for children. Pregnancy and lactation precautions: Contraindicated for pregnant or lactating women. Precautions for the elderly: 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 nicotinic acid, the risk of rhabdomyolysis increases. 2. The incidence and severity of myopathy will be increased when this product is used in combination with methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitors, including gemfibrozil and other fibrates, and 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 blockers 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 in a dark, airtight, cool place. Prevent the instantaneous temperature from exceeding 50℃.

20mg

36 months.

Yichang HEC Changjiang Pharmaceutical Co., Ltd.

• Founded in:

  2001-08-08

• Address:

  No. 38, Binjiang Road, Yidu City, Yichang City, Hubei Province

• Tax NO.:

  91420000730842584F

• Registered Funds:

  879.9677 million yuan

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