Pravastatin Sodium Tablets

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 stage of cholesterol biosynthesis. This product reversibly inhibits HMG-CoA reductase, thereby inhibiting cholesterol biosynthesis. This product exerts its lipid-lowering effect from two aspects. First, it reversibly inhibits the activity of HMG-CoA reductase to reduce 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 strengthening the receptor-mediated decomposition of LDL-C and the clearance of LDL-C in the blood; second, it inhibits the synthesis of LDL-C precursor-very low-density lipoprotein (VLDL-C) in the liver, thereby inhibiting the generation of LDL-C.

Pravastatin sodium (pregnancy classification: X) has a molecular formula of C23H35NaO7 and a molecular weight of 446.52

This drug is white to slightly grayish yellow powder or crystalline powder, odorless, bitter, easily soluble in water, methanol or glacial acetic acid, slightly soluble in anhydrous ethanol, and almost insoluble in anhydrous acetic acid or ether.

Hyperlipidemia, familial hypercholesterolemia.

The starting dose for adults is 10-20 mg/time, once a day, before bedtime. The dose should be increased or decreased appropriately according to age and symptoms, with a maximum daily dose of 40 mg.

Of the total 11,224 cases, 329 (2.93%, this item includes side effects whose incidence cannot be calculated) experienced side effects (including abnormal clinical test values), mainly rash (0.11%), diarrhea (0.08%), stomach discomfort (0.07%), etc. 1 Major adverse reactions (incidence unknown): 1) Rhabdomyolysis: Rhabdomyolysis characterized by muscle pain, fatigue, increased CPK, and increased myoglobin in the blood and urine, followed by severe kidney damage such as acute renal failure. If such symptoms occur, the drug should be discontinued immediately. 2) Hepatic dysfunction: Liver dysfunction accompanied by jaundice, significant increases in AST and ALT, etc. may occur, so it should be observed carefully. In this case, the drug should be discontinued immediately and appropriate treatment should be given. 3) Hematopoietic stem cells

Patients with a history of allergy to this product or any of its ingredients are contraindicated.

Precautions for children: Children should use with caution. Precautions for pregnancy and lactation: Precautions for pregnant and lactating women: Precautions for the elderly: Elderly patients should consider the possibility of reduced renal function caused by advanced age, and should regularly check renal function, observe patient symptoms, and administer medication with caution.

In vivo and in vitro experiments have confirmed that this product is not metabolized by cytochrome P4503A4, so it will not have significant interactions with other drugs metabolized by the cytochrome P450 system (such as phenytoin sodium, quinidine, etc.), nor will it have significant interactions with cytochrome P4503A4 inhibitors (such as diltiazem, itraconazole, ketoconazole, erythromycin, etc.). Warfarin: The simultaneous administration of warfarin and 40 mg of pravastatin sodium will not affect the prothrombin time. Cimetidine: There is no difference between the 0-12 hour AUC of pravastatin when pravastatin sodium is used alone or in combination with cimetidine. The AUC of pravastatin sodium alone or in combination with cimetidine is significantly different from the AUC of pravastatin sodium when it is used in combination with antacids. Digoxin: The bioavailability of digoxin did not change after 0.2 mg of digoxin was co-administered with 20 mg of pravastatin sodium for 9 days; the AUC of pravastatin showed an increasing trend, but the combined bioavailability of pravastatin and its metabolites did not change. Cyclosporine: So far, there are some clinical data on the co-administration of cyclosporine and pravastatin sodium (up to 20 mg in doses), which do not show that the concentration of cyclosporine is affected by pravastatin. Gemfibrozil: Clinical trials have found that the incidence of increased CPK levels and discontinuation due to musculoskeletal symptoms when pravastatin sodium is co-administered with gemfibrozil tends to increase compared with the placebo control group, the gemfibrozil group, and the pravastatin sodium group alone, and the urinary excretion of pravastatin and its protein binding are reduced. It is recommended that pravastatin sodium should not be used in combination with gemfibrozil. Others: There is no significant difference in pharmacokinetics when pravastatin sodium is co-administered with aspirin, antacids (1 hour after taking this product), cimetidine, and niacin. There are no significant drug interactions when used in combination with diuretics, antihypertensive drugs, digitalis, angiotensin-converting enzyme inhibitors, calcium channel blockers, beta-receptor blockers and nitroglycerin.

Keep away from light and store in sealed container.

40 mg

31 May

Daiichi Sankyo Pharmaceutical (SHANGHAI) Co., Ltd.

• Founded in:

  1999-11-18

• Address:

  No. 500, Juli Road, China (Shanghai) Pilot Free Trade Zone

• Tax NO.:

  91310000607410671R

• Registered Funds:

  $53 million

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