Product Overview
[Drug Name]
Generic Name: Pravastatin Sodium Tablets
Trade Name: Puhuizhi
English Name: Pravastatin Sodium Tablets
Chinese Pinyin: Pufatatingna Pian
[Ingredients]
The main ingredient of this product is: Pravastatin sodium. Molecular formula: C23H35NaO7 Molecular weight: 446.52
[Appearance]
This product is a white or off-white tablet.
[Indications]
It is indicated for patients with primary hypercholesterolemia or concomitant hypertriglyceridemia (types IIa and IIb) who cannot be controlled with dietary restrictions.
[Dosage and Administration]
The starting dose for adults is 10 mg to 20 mg once daily, taken at bedtime. The maximum daily dose is 40 mg.
[Adverse Reactions]
Mild elevation of aminotransferases, rash, myalgia, headache, chest pain, nausea, vomiting, diarrhea, and fatigue may occur.
[Contraindications]
This product 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 product 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. 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 concomitant use of this product with these drugs does not increase the incidence of myositis and myopathy.
[Use in Special Populations]
Precautions for Pediatric Use: The safety of this medication in pediatric use has not been established.
Precautions for Pregnancy and Lactation: Contraindicated in pregnant and lactating women.
Precautions for Elderly Patients: The possibility of decreased renal function due to advanced age should be considered. Regular renal function tests should be conducted, symptoms should be monitored, and medication should be administered with caution.
[Drug Interactions]
When this medication is administered one hour before or four hours after cholestyramine, or one hour before colestipol and a standard meal, its bioavailability and therapeutic effect are not clinically significantly reduced. However, if either of these two drugs is taken concomitantly, the bioavailability of this medication decreases by 40% to 50%. When used in combination with antipyrine, this medication does not affect the clearance of antipyrine by the cytochrome P450 system. Because this medication 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 coadministered with warfarin, this product's steady-state bioavailability parameters are unchanged. This product does not alter warfarin binding to plasma proteins, and long-term use of these two drugs does not alter the anticoagulant effect of warfarin. Interaction studies with aspirin, antacids (given 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 coadministration of diuretics, antihypertensives, digitalis, AT-converting enzyme inhibitors, calcium channel blockers, beta-blockers, or nitroglycerin.
[Pharmacological Action]
This product is a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA reductase). HMG-CoA reductase is the rate-limiting enzyme in the initial stages of cholesterol biosynthesis. This product reversibly inhibits HMG-CoA reductase, thereby inhibiting cholesterol biosynthesis. This product exerts its lipid-lowering effects in two ways. First, by reversibly inhibiting HMG-CoA reductase activity, it reduces the amount of intracellular cholesterol 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-C catabolism and LDL-C clearance from the blood. Second, it inhibits LDL-C production by inhibiting the synthesis of very low-density lipoprotein (VLDL-C), the precursor of LDL-C, in the liver.
[Storage] Store in a cool, airtight container away from light.
[Strength] 10mg
[Packaging] 10mg x 12T
[Expiry Date] 18 months
[Approval Number] National Medicine Standard H20050456
[Manufacturer] Shanghai Modern Pharmaceutical Co., Ltd.
