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.

This product is white or off-white tablets.

It is suitable for patients with primary hypercholesterolemia or hypertriglyceridemia (type IIa and IIb) who cannot be controlled by dietary restrictions.

The starting dose for adults is 10mg~20mg, once a day, taken before bedtime, and the maximum daily dose is 40mg.

Mild elevation of aminotransferases, rash, myalgia, headache, chest pain, nausea, vomiting, diarrhea, fatigue, etc. may be seen.

It is contraindicated for patients who are allergic to this product, those with active hepatitis or persistently elevated liver function test results, and pregnant or lactating women.

Precautions for children: Not clear yet. Precautions for pregnancy and lactation: Contraindicated for pregnant and lactating women. Precautions for the elderly: Elderly patients should consider the possibility of reduced renal function due to 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 in a light-proof and airtight container.

10 mg

36 months

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

• Website:

  Log in to view

• Email:

  Log in to view