Atorvastatin Calcium Tablets

This product is a statin blood lipid regulating drug, belonging to the HMG-CoA reductase inhibitor. It is inactive itself. The hydrolysis product after oral absorption competitively inhibits the rate-limiting enzyme hydroxymethylglutaryl coenzyme A reductase in the cholesterol synthesis process in the body, reducing the synthesis of cholesterol and increasing the synthesis of low-density lipoprotein receptors. The main site of action is in the liver, resulting in lower blood cholesterol and low-density lipoprotein cholesterol levels, moderately lower serum triglyceride levels and increased blood high-density lipoprotein levels. This has an effect on the prevention and treatment of atherosclerosis and coronary heart disease.

Atorvastatin calcium.

This product is a white film-coated tablet, which appears white after removing the film coating.

Used to treat hypercholesterolemia and mixed hyperlipidemia; prevent and treat coronary heart disease and cerebral stroke.

Common oral dose for adults: 10-20 mg, once a day, taken at dinner. The dose can be adjusted as needed, but the maximum dose should not exceed 80 mg per day.

1 The most common adverse reaction of this product is gastrointestinal discomfort, and others include headache, rash, dizziness, blurred vision and taste disturbance. 2 It may occasionally cause a reversible increase in blood aminotransferase. Therefore, liver function needs to be monitored. 3 Rare adverse reactions include impotence and insomnia. 4 Rare adverse reactions include myositis, myalgia, and rhabdomyolysis, which are manifested as muscle pain, fatigue, fever, and are accompanied by increased blood creatine phosphokinase, myoglobinuria, etc. Rhabdomyolysis can lead to renal failure, but it is rare. The combination of this product with immunosuppressants, folic acid derivatives, niacin, gemfibrozil, erythromycin, etc. can increase the risk of myopathy. 5 Hepatitis, pancreatitis and allergic reactions such as angioedema have been reported.

1. Patients who are allergic to atorvastatin are contraindicated. Patients who are allergic to other HMG-CoA reductase inhibitors should use with caution. 2. Patients with active liver disease or unexplained persistent elevation of blood aminotransferase are contraindicated.

Precautions for children: This product should only be used in children by specialists. The 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 for pregnancy and lactation: Pregnancy classification X1. Pregnant women or women of childbearing age who may become pregnant are prohibited from taking Lipitor. 1.1 Serum cholesterol and triglyceride levels in the body are elevated during normal pregnancy, and cholesterol or cholesterol derivatives are essential substances for fetal development. Atherosclerosis is a chronic disease process, so the discontinuation of lipid-lowering drug treatment during pregnancy in patients with primary hypercholesterolemia has little effect on the long-term outcome of atherosclerotic disease. 1.2 There is currently a lack of adequate controlled studies on the use of Lipitor during pregnancy. There are rare reports of congenital abnormalities caused by intrauterine exposure to statins. A follow-up study of approximately 100 pregnant women exposed to other statins found that the incidence of congenital anomalies, spontaneous abortion, and fetal death/stillbirth did not exceed the expected values for the general population, but this study could only exclude a risk of 3-4 times the baseline incidence of congenital anomalies. At the same time, 89% of the patients started taking the drug before pregnancy but stopped taking it within 3 months after being informed of pregnancy. 1.3 Atorvastatin crosses the placenta of rats and reaches drug levels in the fetal liver that are equivalent to maternal plasma. Atorvastatin did not produce teratogenic effects when dosed up to 300 mg/kg/day in rats and 100 mg/kg/day in rabbits. Based on body surface area (mg/m2), these doses are approximately 30 times (rats) or 20 times (rabbits) the human exposure (see [Contraindications], Pregnancy). 1.4 In one study, rats were dosed with 20, 100, or 225 mg/kg/day from gestation day 7 to lactation day 21 (weaning). The survival of pups at birth, neonatal, weaning, and maturity was reduced when the mothers were dosed with 225 mg/kg/day. The weight of pups on days 4 and 21 was reduced when the mothers were dosed with 100 mg/kg/day; the weight of pups at birth, days 4, 21, and 91 was reduced when the mothers were dosed with 225 mg/kg/day; the development of pups was delayed (Rothel's syndrome occurred at 100 mg/kg/day, while auditory startle response occurred at 225 mg/kg/day; auricular separation and palpebral fissures occurred at 225 mg/kg/day). These doses are equivalent to 6 times (100 mg/kg/day) and 22 times (225 mg/kg/day) the area under the curve of humans taking 80 mg daily. 1.5 Statins may harm the fetus when given to pregnant women. Women of childbearing age should only take this product when the possibility of pregnancy is extremely small and they have been informed of the potential risks of the drug to pregnant women. Once a woman taking this product becomes pregnant, the drug should be stopped immediately and informed of the potential risks to the fetus. There is a lack of known clinical benefits to continuing the drug during pregnancy. 2. It is not clear whether atorvastatin is secreted through human milk in lactating women, but another similar drug can be secreted into breast milk in small amounts. The atorvastatin drug concentrations in the plasma and liver of lactating rat pups are 50% and 40% of the drug concentrations in breast milk, respectively. The drug concentration level in animal milk may not accurately reflect the drug concentration level in human milk, because another similar drug can be secreted through human milk. At the same time, statins may cause serious adverse reactions to newborns receiving breastfeeding. Therefore, mothers taking this product should not breastfeed (see [Contraindications]). Elderly precautions: 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 is no difference in overall safety and efficacy between these two populations and young subjects. Other clinical experience reports also show no difference between the elderly and young populations. However, it cannot be ruled out that some elderly patients are more sensitive to drugs, and advanced age (≥65 years old) is a susceptibility factor for myopathy, so Lipitor should be used with caution in the elderly.

1. The combination of this product with oral anticoagulants can prolong the prothrombin time and increase the risk of bleeding. 2. The combination 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.

Seal tightly and store in a dry place below 25℃.

20 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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