Product Overview
[Drug Name]
Generic Name: Pravastatin Sodium Tablets
Trade Name: Futaning
English Name: Pravastatin Sodium Tablets
Chinese Pinyin: Pufatatingna Pian
[Ingredients]
Pravastatin sodium. Molecular formula: C23H35NaO7, molecular weight: 446.52.
[Properties]
Reddish bare tablets with a crosshatch pattern on one side, odorless, slightly bitter.
[Indications]
Indicated for primary hypercholesterolemia (types IIa and IIb) that cannot be controlled with dietary restrictions.
[Dosage and Administration]
The starting dose for adults is 10mg-20mg once daily, taken at bedtime. The maximum daily dose is 40mg.
[Adverse Reactions]
Adverse reactions may include mild transaminase elevation, rash, myalgia, headache, chest pain, nausea, vomiting, diarrhea, and fatigue.
[Contraindications]
This drug is contraindicated in patients with allergies, active hepatitis, or persistently elevated liver function tests, as well as pregnant or lactating women.
[Precautions]
1. Poor efficacy in homozygous familial hypercholesterolemia. 2. Liver function tests should be performed regularly during treatment. If SGPT and SGOT levels are elevated equal to or greater than three times the upper limit of normal and persist, treatment should be discontinued. 3. This drug should be used with caution in patients with a history of liver disease or alcohol consumption. 4. HMG-CoA reductase inhibitors may occasionally cause elevated CPK levels. If the elevation exceeds 10 times the upper limit of normal, use should be discontinued. During use, patients should report unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise and fever, to a physician immediately. 5. Concomitant use of other HMG-CoA reductase inhibitors with cyclosporine, fibric acid derivatives, niacin, and other lipid-lowering drugs can increase the incidence of myositis and myopathy. However, clinical trials have shown that this drug does not increase the incidence of myositis and myopathy when used concomitantly with these drugs.
[Use in Special Populations]
Precautions for Children:
Although international studies have evaluated the efficacy and safety of this drug at a daily dose of 40 mg in children and adolescents aged 8-18 years, no data are available in Chinese populations under 18 years of age. Therefore, use in patients under 8 years of age is not currently recommended.
Pregnancy and Lactation Precautions:
This drug is contraindicated in pregnant and lactating women.
Precautions for the Elderly:
The mean oral AUC of pravastatin is slightly higher in the elderly (25-50%) than in healthy young adults, but the mean Cmax, Tmax, and half-life are not different between the two groups. Pravastatin exhibits significant accumulation in the elderly.
[Drug Interactions]
Administering this drug one hour before or four hours after cholestyramine or one hour before colestipol and a standard meal does not significantly reduce its bioavailability or therapeutic effect. However, coadministration of either drug can reduce its bioavailability by 40% to 50%. When used in combination with antipyrine, this product does not affect the clearance of antipyrine by the cytochrome P450 system. Since this product does not induce hepatic drug-metabolizing enzymes, it does not significantly interact with other drugs metabolized by the cytochrome P450 system (such as phenytoin and quinidine). When used in combination with warfarin, this product's steady-state bioavailability parameters do not change, nor does it alter warfarin's plasma protein binding. Long-term use of these two drugs does not alter the anticoagulant effect of warfarin. Interaction studies with aspirin, antacids (administered one hour before this product), cimetidine, gemfibrozil, niacin, or probucol did not reveal significant differences in its bioavailability. While antacids and cimetidine may alter its plasma concentration, this does not affect its efficacy. No significant interactions have been observed with diuretics, antihypertensives, digitalis, AT-converting enzyme inhibitors, calcium channel blockers, beta-blockers, or nitroglycerin.
[Pharmacological Action]
It is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA reductase), the rate-limiting enzyme in the initial stages of cholesterol biosynthesis. It reversibly inhibits HMG-CoA reductase, thereby inhibiting cholesterol biosynthesis. Its lipid-lowering effects are twofold. First, by reversibly inhibiting HMG-CoA reductase activity, it reduces intracellular cholesterol levels to a certain extent, leading to an increase in the number of low-density lipoprotein (LDL) receptors on the cell surface, thereby enhancing receptor-mediated LDL catabolism and LDL clearance from the blood. Second, it inhibits the synthesis of very low-density lipoprotein (VLDL-C), the precursor of LDL, in the liver, thereby inhibiting LDL-C production.
[Storage] Store in a cool, dark, and airtight container.
[Specification] 10mg
[Packaging] Aluminum-plastic packaging. Validity Period: 24 months
Approval Number: National Medicine Standard H20050736
Manufacturer: North China Pharmaceutical Co., Ltd.
