Product Overview
[Drug Name]
Generic Name: Simvastatin Tablets
Trade Name: Yongshengtang Simvastatin Tablets 10mg*30 Tablets
Pinyin Full Code: YongShengTanginFaTaTingPian1mg*30Tablets
Main Ingredient:
Simvastatin.
[Properties]
This product is a white or off-white tablet.
[Indications/Main Functions]
1. Hypercholesterolemia: When dietary therapy and other non-drug treatments are inadequate, simvastatin can be used to lower total cholesterol and LDL-C in patients with primary hypercholesterolemia. Simvastatin also increases HDL-C, thereby reducing the LDL-C/HDL-C and total-HDL-C ratios. It can also reduce elevated cholesterol levels in patients with combined hypercholesterolemia and hypertriglyceridemia, where hypercholesterolemia is the primary abnormality. 2. Coronary Heart Disease: For patients with coronary heart disease, simvastatin is indicated for: reducing the risk of death; reducing the risk of coronary heart disease. Reduce the risk of death and nonfatal myocardial infarction; reduce myocardial revascularization procedures (coronary artery bypass grafting and percutaneous transluminal coronary angioplasty); and slow the progression of atherosclerosis, including the development of new lesions and complete blockages.
[Specifications]
10mg*30 tablets
[Dosage and Administration]
Patients should follow a standard cholesterol diet before starting simvastatin therapy and continue taking Yuanlijian Simvastatin tablets during treatment. Hypercholesterolemia: The general initial dose is 10 mg daily, taken once in the evening. For patients with mild to moderately elevated cholesterol levels, the initial dose is 5 mg daily. Dose adjustments should be made at least four weeks apart, with a maximum dose of 40 mg daily, taken once in the evening. The simvastatin dose should be reduced when the LDL cholesterol level drops to 75 mg/dL (194 mmol) or the total cholesterol level drops below 140 mg/day (3.6 mmol). Patients with coronary artery disease can take 20 mg daily as a starting dose. If dose adjustment is necessary, refer to the instructions above (Usage and Dosage for Hypercholesterolemia). Concomitant Therapy: Simvastatin is effective when used alone or in combination with bile acid initiators. For patients taking concomitant immunosuppressive drugs, the recommended dose of simvastatin is 10 mg daily. Patients with Renal Impairment: Because simvastatin is not significantly excreted by the kidneys, no dose adjustment is required for patients with moderate renal impairment. However, for patients with severe renal impairment (creatinine clearance 30 m/min), doses exceeding 10 mg daily should be carefully considered and used with caution.
[Adverse Reactions]
Simvastatin is generally well tolerated, with most adverse reactions being mild and transient. In controlled clinical trials, less than 2% of patients discontinued simvastatin due to adverse reactions. In controlled clinical trials, adverse reactions (categorized as Adverse reactions (possibly, suspected, or definitely) attributed to the drug at an incidence greater than or equal to 1% include: abdominal pain, constipation, and flatulence. Adverse reactions occurring in 0.5% to 0.9% of patients include fatigue and headache. Reports of myopathy are rare. The following adverse reactions have been reported in uncontrolled clinical trials or in marketed applications. Pruritus and anemia have been reported rarely. Rhabdomyolysis and hepatitis have been reported rarely. Jaundice has been reported rarely. A frank hypersensitivity reaction syndrome with one or more of the following features has been reported rarely: angioedema, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, nicotinic acidosis, arthritis, arthralgia, hives, fever, pyrexia, flushing, difficulty breathing, and malaise. Laboratory findings: Significant and persistent elevations of serum transaminases have been reported rarely. Liver function test abnormalities have been mild or transient. Elevations of serum creatine kinase (CK), derived from skeletal muscle, have been reported.
[Contraindications]
1. Hypersensitivity to any component of this product; 2. Active hepatitis or unexplained persistent elevation of serum transaminases; 3. Pregnant or lactating women.
[Drug Interactions]
1. The risk of rhabdomyolysis is increased when simvastatin is used in combination with other drugs that significantly inhibit cytochrome P450 3A4 at therapeutic doses (e.g., cyclosporine, mibefradil, itraconazole, ketoconazole, erythromycin, clarithromycin, and nefazodone), or fibric acid derivatives or niacin. 2. Concomitant use of Yuanlijian simvastatin tablets with methylhydroxyglutaryl coenzyme A (HMG-CoA) reductase inhibitors, including gemfibrozil and other fibrates, as well as lipid-lowering drugs, may increase the incidence and severity of myopathy. Niacin is greater than or equal to 1g/d. In addition, high levels of plasma methylhydroxyglutaryl coenzyme A HMG-COA reductase inhibitor activity can 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 thereby increase the risk of myopathy. These drugs include cyclosporine, tetralins, the calcium channel blocker mibefradil, itraconazole, ketoconazole and other antifungal azoles, the macrolide antibiotics erythromycin and clarithromycin, and anti-inhibitors. Nefazodone. 3. Coumarin: Clinical studies have shown that simvastatin can moderately enhance the anticoagulant effect of coumarin anticoagulants. Therefore, when adults begin early anticoagulant therapy and concurrently use simvastatin, frequent prothrombin time monitoring is recommended to ensure that the prothrombin time does not significantly change. Even after a stable prothrombin time has been achieved in patients taking ophthalmic coumarin derivatives, continued prothrombin time monitoring is recommended for a fixed period. The same procedure should be followed if the simvastatin dose is changed. In patients not taking anticoagulants, simvastatin therapy has not been reported to affect bleeding or prothrombin time.
[Precautions]
1. Hepatic reactions. In clinical trials, a small number of patients taking Yuanlijian simvastatin have experienced hepatic reactions. Patients who take statins have a significant phenomenon of persistent elevation of serum transaminases (more than 3 times the normal value). However, after discontinuation of the drug, the transaminases can return to the pre-treatment level, but there is no jaundice or other related clinical symptoms or signs, and no allergic reactions. It is recommended that patients with elevated transaminases should be examined more closely and paid more attention before treatment. If the patient's transaminase continues to rise, especially if the transaminase rises by more than three times the normal value and remains persistent, the drug should be discontinued. This drug should be used with caution in patients who drink a lot of alcohol or have a history of liver disease. Simvastatin should be contraindicated in patients with active liver disease or unexplained elevation of transaminases. As with other lipid-lowering drugs, patients treated with simvastatin have moderate elevations of transaminases (less than three times the normal value). There have also been reports. These changes usually appear soon after the application of simvastatin treatment, but they are generally transient and not accompanied by any symptoms, so there is no need to stop the drug. 2. Muscle reaction. Patients treated with Yuanlijian Simvastatin Tablets generally have a mild transient increase in creatine kinase (CK) (from skeletal muscle), but these have no clinical significance. Myopathy should be considered in cases of diffuse myalgia, muscle weakness or/and significant increase in creatine phosphate (CK) (more than ten times the normal value). Therefore, patients should be asked to tell their doctor immediately if they have unexplained myalgia, muscle weakness or muscle weakness. If a significant increase in creatine kinase (CK) is found or myalgia is diagnosed or suspected, simvastatin treatment should be stopped immediately. For those with acute or Patients with severe conditions suggestive of myopathy and those at risk for secondary acute renal failure due to rhabdomyolysis should discontinue treatment with methylhydroxyglutaryl coenzyme A (HMG-CoA) reductase inhibitors. 3. Ophthalmological examination: Even without any medication, the incidence of lens opacities increases with age. Long-term clinical study data show that simvastatin has no adverse effects on the human lens. 4. Pregnancy Use: No data are available on the use of simvastatin during pregnancy. Simvastatin is contraindicated in pregnant women. Because atherosclerosis is a chronic process, discontinuing lipid-lowering drugs during pregnancy has little effect on the long-term efficacy of treating primary hypercholesterolemia. Furthermore, cholesterol and other products of its biosynthesis, including steroids, are essential for fetal development. and cell membrane synthesis. Because HMG-COA reductase inhibitors such as simvastatin can reduce cholesterol synthesis and other products of the cholesterol biosynthesis pathway, simvastatin use by pregnant women may harm the fetus. Among women of childbearing age, simvastatin should only be used in those with a low probability of pregnancy. If a woman becomes pregnant while taking this medication, simvastatin should be discontinued and the woman should be informed of the potential harm to the fetus. 5. Breastfeeding Women: It is not known whether simvastatin and its metabolites are secreted in human milk, as many drugs are secreted in human milk and because of the potential serious side effects of this product, women taking simvastatin should not breastfeed. 6. Pediatric Use: The safety and effectiveness of this medication for pediatric use have not been established. Simvastatin is not currently recommended for children. 7. Elderly Use: In controlled clinical trials of simvastatin in elderly patients (over 65 years of age), its efficacy in lowering total cholesterol and LDL cholesterol was comparable to that of other populations, without a significant increase in the frequency of side effects or laboratory abnormalities. 8. Homozygous Familial Hypercholesterolemia: Because patients with homozygous familial hypercholesterolemia completely lack the low-density lipoprotein (DL-L) receptor, simvastatin is less effective in treating this condition. 9. Hypertriglyceridemia: Simvastatin has only a moderate triglyceride-lowering effect and is not suitable for treating conditions characterized by elevated triglycerides (such as Types I, V, and V hyperlipidemia).
