Product Overview
[Drug Name]
Generic Name: Simvastatin Tablets
Trade Name: Simvastatin Tablets 20mg x 14 Tablets
[Main Ingredient]
Simvastatin.
[Properties]
This product is a film-coated tablet that appears white or off-white after removal of the film coating.
[Indications/Main Functions]
For the treatment of hyperlipidemia and coronary heart disease.
[Specifications]
20mg x 14 tablets
[Dosage and Administration]
Oral administration: Split the tablets if necessary. 1. Hypercholesterolemia: The general starting dose is 10mg (1/2 tablet) per day, taken in the evening. For patients with mild to moderately elevated cholesterol levels, the starting dose is 5mg (1/4 tablet) per day. Dosage adjustments should be made at least four weeks apart, with a maximum dose of 40mg (2 tablets) per day, taken in the evening. When LDL cholesterol levels drop to 75 mg/dL (1.94 mmol/L) or total cholesterol levels drop below 140 mg/dL (3.6 mmol/L), the simvastatin dosage should be reduced. 2. Homozygous Familial Hypercholesterolemia: Based on the results of controlled clinical studies, the recommended dose of simvastatin for patients with homozygous familial hypercholesterolemia is 40 mg (2 tablets) of simvastatin taken in the evening, or 80 mg (4 tablets) taken in three divided doses: 20 mg (1 tablet) in the morning, 20 mg (1 tablet) at noon, and 40 mg (2 tablets) in the evening. Simvastatin should be used in combination with other lipid-lowering therapies, such as LDL aspiration. When these methods are unavailable, simvastatin can be used alone. 3. Coronary Artery Disease: Patients with coronary artery disease can take 20 mg (1 tablet) daily in the evening as a starting dose. If dose adjustment is necessary, refer to the instructions above (Usage and Dosage for Hypercholesterolemia). 4. Concomitant Therapy: Simvastatin is effective when used alone or in combination with bile acid sequestrants. For patients taking concomitant immunosuppressants, the recommended dose of simvastatin is 10 mg (i.e., 1/2 tablet) per day. 5. 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 (myosin clearance less than 30 m/min), the use of doses exceeding 10 mg (i.e., 1/2 tablet) per day 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.
[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]
Not yet known.
[Precautions]
1. Patients should follow a standard cholesterol diet before starting simvastatin therapy and continue using it during treatment. 2. Hepatic Reactions: This drug should be used with caution in patients who consume large amounts of alcohol and/or have a history of liver disease. Simvastatin should be contraindicated in patients with active liver disease or unexplained elevations in aminotransferases. In clinical trials, a small number of patients taking simvastatin experienced significant, persistent elevations in serum aminotransferase levels (more than three times the normal value). However, after discontinuation of the drug, the aminotransferase returned to pre-treatment levels, but there was no jaundice or other related clinical symptoms or signs, nor any allergic reactions. It is recommended that patients with elevated aminotransferase levels should be examined more closely and paid more attention before treatment. If the patient's aminotransferase continues to rise, especially if the elevation exceeds two times the normal value and persists, the drug should be discontinued. Similar to other lipid-lowering drugs, moderate elevations in aminotransferase levels (less than three times the normal value) have also been reported in patients treated with simvastatin. These changes usually occur shortly after treatment with simvastatin, but are generally transient and not accompanied by any symptoms, so discontinuation of the drug is not necessary. Muscle Reactions: Mild, transient elevations of creatine kinase (CK), derived from skeletal muscle, are common in patients treated with simvastatin, but these elevations are clinically insignificant. Diffuse myalgia, muscle weakness, and/or significant elevations of creatine kinase (CK) (more than ten times the normal value) should be considered a myopathy. Therefore, patients should be instructed to report any unexplained signs of myopathy to their physician immediately. If a significant elevation of creatine kinase (CK) is observed or myalgia is diagnosed or suspected, simvastatin treatment should be discontinued immediately. Methylhydroxyglutaryl coenzyme A (HMG-COA) reductase inhibitors should be discontinued in patients with acute or severe conditions suggestive of myopathy and those at risk for secondary acute renal failure due to rhabdomyolysis. Treatment with preparations. 3. Ophthalmological examination. Even without any drug treatment, the incidence of lens opacity increases with age. Long-term clinical research data show that simvastatin has no adverse effects on the human lens. 4. Homozygous familial hypercholesterolemia. Due to the complete lack of low-density lipoprotein (LD) receptors in patients with homozygous familial hypercholesterolemia, simvastatin is not very effective in treating such patients. 5. Hypertriglyceridemia. Simvastatin has only a moderate effect in reducing triglycerides (triglycerides) and is not suitable for treating abnormal conditions characterized by elevated triglycerides (such as type I, IV, and V hyperlipidemia). 6. For patients who drink too much alcohol and/or have This drug should be used with caution in patients with a history of liver disease.
[Pediatric Use]
The safety and efficacy of simvastatin in patients aged 10-17 years with heterozygous familial hypercholesterolemia were evaluated in a controlled trial conducted in adolescent boys and girls (at least 1 year after menarche). Adverse events in patients treated with simvastatin were generally similar to those in the placebo group. No studies have been conducted in this population using doses greater than 40 mg. In this limited controlled study, simvastatin was not found to have a significant effect on growth or sexual maturation in adolescent boys or girls, or on menstrual cycle length in adolescent girls. (See Dosage and Administration; Adverse Reactions; Clinical Trials.) Simvastatin therapy is recommended for adolescent girls. Use appropriate contraception during treatment. (See Contraindications; Precautions; Use in Pregnant and Lactating Women.) Simvastatin has not been studied in patients younger than 10 years of age or in premenarchal girls.
[Use in Elderly Patients]
In controlled clinical studies of simvastatin in elderly patients (>65 years), its effects on lowering total cholesterol and LDL cholesterol were similar to those in other populations, and there was no significant increase in the incidence of adverse reactions or laboratory abnormalities.
[Overdose]
There have been a few reports of overdose; the maximum dose was 3.6 g. All patients recovered without sequelae. Conventional measures are generally used to manage overdose.
[Pharmacology and Toxicology]
Not yet known.
