Atorvastatin Calcium Tablets

Antipyrine: Since atorvastatin calcium does not affect the metabolism of antipyrine, it does not interact with drugs metabolized by the same cytochrome isoenzymes. Colestipol (hyperlipidemic drug): When administered simultaneously with atorvastatin calcium, the plasma concentration of atorvastatin calcium decreased by 25%, and the decrease in LDL-C was more significant than when either drug was administered alone. Cimetidine: The plasma concentration of atorvastatin calcium and the decrease in LDL-C did not change when administered simultaneously. Digoxin: When administered simultaneously, the steady-state plasma concentration of digoxin increased by 20%, and patients taking digoxin should be monitored carefully. Erythromycins: When these two drugs are used simultaneously in normal people, the plasma concentration of atorvastatin calcium increases by 40%. Oral contraceptives: When administered simultaneously, the areas under the curve of oral norethindrone and ethinyl estradiol increase by 30% and 20%, respectively. Women taking atorvastatin calcium should consider this when choosing oral contraceptives. Warfarin: Atorvastatin calcium has no effect on the coagulation time of patients taking warfarin. Other concurrent treatments: No clinical adverse interactions were found when atorvastatin calcium was given concurrently with antihypertensive and estrogen replacement therapy.

The chemical name of this product is: [R-(R′,R′)]-2-(4-fluorophenyl)-bd-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(aniline)carbonyl]-1-hydrogen-pyrrole-1-heptanoic acid calcium trihydrate.

This product is a white film-coated tablet. After removing the film coating, it appears white.

1. Primary hypercholesterolemia and mixed hyperlipidemia, to reduce elevated TC, LDL-C, ApoB and TG levels. 2. Patients with hypercholesterolemia and risk of atherosclerosis.

Oral administration, once a day, 1 tablet each time or as directed by a physician. Patients should follow a standard low-cholesterol diet before and during treatment with atorvastatin calcium. The recommended starting dose of atorvastatin calcium is 10 mg/day, with a dose range of 10 to 60 mg/day. Blood lipid levels should be monitored within 2-4 weeks of use, and the dose should be adjusted accordingly based on the treatment goals and efficacy response.

This product is well tolerated, and adverse reactions are usually mild and short-lived. A clinical study of 2,502 patients abroad showed that less than 2% of patients discontinued medication due to adverse reactions. The most common side effects are constipation, flatulence, indigestion and abdominal pain, and occasional mild elevation of serum transaminases and creatine phosphokinase, which generally do not require discontinuation of the drug. Less than 2% of patients have the following adverse reactions: gastritis, gastroenteritis, dry mouth, anorexia, leg cramps, myositis, muscle weakness, fever, discomfort, photosensitivity, drowsiness, forgetfulness, dreaminess, decreased libido, postural hypotension, palpitations, etc.

1. People who are allergic to this product. 2. People with active liver disease or unexplained persistent elevation of serum transaminase. 3. Pregnant women and women in the perinatal period.

Precautions for children: This product should only be used in children by specialists. The treatment experience of this product in children is limited to a small number of patients (4 to 17 years old) with severe lipid disorders such as homozygous familial hypercholesterolemia. The recommended starting dose of this product in this patient population is 10 mg/day. There is no safety data on the growth and development of this population. Precautions during pregnancy and lactation: Pregnant women and perinatal women are prohibited. Precautions for the elderly: Among the 39,828 patients taking Lipitor in clinical studies, 15,813 (40%) were ≥65 years old and 2,800 (7%) were ≥75 years old. There was no difference in overall safety and effectiveness between these two populations and young subjects. Other clinical use experience reports also show that there is no difference between the elderly and young populations. However, it cannot be ruled out that some elderly patients are more sensitive to drugs. Advanced age (≥65 years old) is a susceptibility factor for myopathy, so Lipitor should be used with caution in the elderly.

(1) The combined use of this product with oral anticoagulants can prolong the prothrombin time and increase the risk of bleeding. (2) The combined use of this product with immunosuppressants such as cyclosporine, erythromycin, gemfibrozil, niacin, etc. can increase the risk of myolysis and acute renal failure. (3) Colestipol and cholestyramine can reduce the bioavailability of this product, so this product should be taken 4 hours after taking the former.

Keep away from light and store in sealed container.

40 mg

36 months.

Viatris Pharmaceuticals (DALIAN) Co., Ltd.

• Founded in:

  1989-10-07

• Address:

  No. 22 Daqing Road, Dalian Economic and Technological Development Zone, Liaoning Province

• Tax NO.:

  912102006048147187

• Registered Funds:

  $80.4 million

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