Simvastatin Tablets

Simvastatin can reduce normal and elevated low-density lipoprotein cholesterol (LDL-C) concentrations. LDL is formed from very low-density lipoprotein (VLDL) and is mainly degraded by high-affinity LDL receptors. The mechanism by which simvastatin reduces LDL-C mainly includes: reducing the concentration of VLDL-cholesterol, inducing LDL receptors, leading to a decrease in LDL cholesterol and increasing the catabolism of LDL-C. During simvastatin treatment, the level of apolipoprotein B (apoB) also decreased significantly. Since each LDL particle contains one molecule of apoB, and apoB rarely appears in other lipoproteins, this also suggests that simvastatin can not only cause cholesterol to be lost from LDL, but also reduce the concentration of circulating LDL particles. In addition, simvastatin can increase the concentration of high-density lipoprotein cholesterol (HDL-C) and reduce plasma triglycerides (TG). These can all lead to a decrease in total cholesterol/HDL-C and LDL-C/HDL-C.

The main ingredient of this product is simvastatin. Chemical name: 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

This product is a film-coated tablet, which appears white or off-white after removing the coating.

Hyperlipidemia, coronary heart disease, hypercholesterolemia.

Before receiving treatment with this product, patients should follow a standard cholesterol-lowering diet and continue to maintain it during treatment. The recommended starting dose is 20 mg per day, taken once in the evening. For patients who only need a moderate reduction in LDL cholesterol, the starting dose is 10 mg. For patients who are also taking cyclosporine, danazol, fibrates (except fenofibrate) or niacin, amiodarone, verapamil, and severe renal insufficiency, the recommended doses are as follows. The recommended dosage range is 5-80 mg per day, taken once in the evening, and the dose should be individualized based on baseline LDL cholesterol levels, recommended treatment goals, and patient response. Dose adjustments should be made at intervals of 4 weeks or more. Cholesterol levels should be monitored regularly, and when LDL cholesterol levels drop to 75 mg

1. This product is generally well tolerated, and most adverse reactions are mild and transient. In controlled clinical studies, less than 2% of patients discontinued the drug due to adverse reactions of this product. In pre-marketing controlled clinical studies, the adverse reactions that researchers believed were drug-related (divided into possible, very likely or certain) and with an incidence of ge;1% included abdominal pain, constipation and gastrointestinal flatulence; the adverse reactions with an incidence of 0.5-0.9% included fatigue and headache. Reports of myopathy are rare. 2. In the HPS study (see clinical trials), a total of 20,536 patients took 40 mg of this product (n=10,269) or placebo (n=10,267) daily, with an average observation time of 5 years, and the safety of the two groups was similar. This large trial only recorded serious adverse reactions and the number of people who withdrew from the study due to side effects. The proportion of withdrawal due to adverse reactions between the two groups was similar (4.8% in the simvastatin group and 5.1% in the placebo group). The incidence of myopathy in the simvastatin group was less than 0.1%. The proportion of elevated transaminases (more than 3 times the upper limit of normal value in repeated examinations) in the simvastatin group and the placebo group was 0.21% (n=21) and 0.09% (n=9), respectively. 3. In the Nordic Simvastatin Survival Study (4S), 4444 patients took 20-40 mg of this product (n=2221) or placebo (n=2223) daily, with a median follow-up time of 5.4 years. The safety and tolerability of the two groups were similar. 4. Reported in uncontrolled clinical studies or post-marketing applications.

1. Those who are allergic to any component of this product. 2. Those with active liver disease or unexplained persistent elevation of serum transaminase. 3. Pregnant and lactating women (see Precautions, Use in Pregnant and Lactating Women).

Precautions for children: The safety and efficacy of simvastatin in patients with heterozygous familial hypercholesterolemia aged 10-17 years has 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 studies with doses greater than 40 mg have been conducted in this population. 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) Precautions for pregnancy and lactation in patients younger than 10 years of age and those at menarche: 1. Pregnant women. This product is contraindicated in pregnant women. There are no safety data on simvastatin for pregnant women. No controlled clinical trials of simvastatin have been conducted in pregnant women. There are also rare reports of congenital 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 was statistically sufficient to exclude the possibility that the incidence of birth defects was no more than 2.5 times higher than the normal incidence. Although there is no clear evidence that pregnant women using simvastatin will increase the incidence of birth defects, simvastatin can reduce fetal mevalonate (Elderly Note: In controlled clinical studies of simvastatin in elderly patients (>65 years), its effect on lowering total cholesterol and low-density lipoprotein cholesterol was similar to that of other populations, and the incidence of adverse reactions and laboratory abnormalities was not significantly increased.

1. Interaction with CYP3A4. Simvastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore, it does not affect the plasma concentrations of other drugs metabolized by CYP3A4. Effective CYP3A4 inhibitors (as follows) increase the risk of myopathy by reducing the elimination of simvastatin (see Precautions, Myopathy/Rhabdomyolysis). Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromcin, HIV protease inhibitors, Nefazodone. 2. Interaction with other lipid-lowering drugs that can cause myopathy when used alone. The risk of myopathy is increased when used in combination with the following lipid-lowering drugs, which are not effective CYP3A4 inhibitors but can cause myopathy when used alone. Gemfibrozil, others

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

40mg*5s

24 months