Zocor Simvastatin Tablets
Function and Efficacy
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).
Ingredients
Molecular weight: C25H38O5
| Name | Description | Content | CAS NO. | Manufacturer |
|---|---|---|---|---|
| 102418-79-1Ingredients |
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). More |
102418-79-1 | 0 |
Appearance
This product is a pink oval film-coated tablet with MSD749 engraved on one side; it appears white or off-white after the film coating is removed.
Indication
Used for patients with hypercholesterolemia, primary hypercholesterolemia, heterozygous familial hypercholesterolemia or mixed hypercholesterolemia, etc.
Usage and Dosage
Patients should follow a standard cholesterol-lowering diet before receiving simvastatin treatment and continue to maintain it during treatment. 1. Hypercholesterolemia: The general starting dose is 10 mg per day, taken in the evening. For patients with mild to moderately elevated cholesterol levels, the starting dose is 5 mg per day. If the dose needs to be adjusted, an interval of more than four weeks should be made, and the maximum dose is 40 mg per day, taken in the evening. Cholesterol levels should be monitored regularly, and if cholesterol levels are significantly lower than the target range, a reduction in the dose of simvastatin should be considered. 2. Coronary heart disease: Patients with coronary heart disease can start with a dose of 20 mg/day. If the dose needs to be adjusted, an interval of more than four weeks should be made, and the maximum dose is 40 mg per day, taken in the evening. 3. Concomitant medication: Simvastatin is effective when used alone or in combination with a bile acid chelator. In general
Adverse Reactions
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 the drug were: abdominal pain, constipation, and flatulence. Adverse reactions with an incidence of 0.5% to 0.9% included 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, alopecia, dizziness, muscle cramps, myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting and anemia, rhabdomyolysis and hepatitis/jaundice are rare.
Precautions
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.
Special Population Medication
Precautions for children: The safety and effectiveness of the drug for children have not 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, they can also reduce other products of the cholesterol biosynthetic pathway. Therefore, pregnant women taking simvastatin may be harmful to 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 the elderly of the possible effects on the fetus. Precautions: In elderly patients (over 65 years old), in controlled clinical trials using simvastatin, its effects on lowering total cholesterol and low-density lipoprotein (LDL) cholesterol were the same as those in other populations, and the frequency of adverse reactions and abnormal laboratory tests did not increase significantly.
Drug Interactions
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, 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 may also increase the risk of myopathy.
Storage
Keep away from light and store in sealed container.
Packaging Specification
40mg*5s
Validity Period
24 months