Atorvastatin Calcium Tablets

Atorvastatin calcium.

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

Before starting treatment with this product, patients should follow a standard low-cholesterol diet and maintain a reasonable diet throughout the treatment period. The dose should be adjusted individually based on the baseline level of low-density lipoprotein cholesterol, treatment goals, and the patient's treatment effect. The commonly used starting dose is 10 mg once a day. The dose adjustment interval should be 4 weeks or longer. The maximum dose of this product is 80 mg once a day. It can be taken at any time of the day and is not affected by meals. For patients at low risk of cardiovascular events, the treatment goal is LDL-C <4.14mmol/L (or <160mg/dL) and total cholesterol <6.62mmol/L (or <240mg/dL). The treatment goal for moderate-risk patients is LDL-C <l

The following serious adverse reactions are described in detail elsewhere in this instruction manual; Rhabdomyolysis and myopathy (see [Precautions]) Abnormal liver enzymes (see [Precautions]) Clinical adverse reactions The conditions of the subjects are complex during the implementation of clinical trials. Therefore, the incidence rates of adverse reactions obtained in clinical studies of two different drugs cannot be directly compared, and may not reflect the incidence rates of adverse reactions in clinical practice. A total of 16,066 patients were included in the placebo-controlled clinical trials of atorvastatin (Lipitor n=8755, placebo n=7311, aged from 10 to 93 years old, 39% were female; 91% were Caucasians, 3% were blacks, 2% were Asians, and 4% were other races). The median treatment period was 53 weeks. Without considering causality, atorvastatin

1. Active liver disease, which may include unexplained persistent elevation of liver transaminases. 2. Known allergy to any ingredient in this product. 3. Pregnancy. This product is prohibited for use by pregnant women or women of childbearing age who may become pregnant. This product may cause harm to the fetus when taken by pregnant women. In normal pregnancy, serum cholesterol and triglyceride levels in the body are elevated, and 4. Cholesterol or cholesterol derivatives are essential substances for fetal development. Atherosclerosis is a chronic disease process, so discontinuation of lipid-lowering drug treatment during pregnancy in patients with primary hypercholesterolemia has little effect on the long-term outcome of atherosclerotic disease. There is currently a lack of adequate controlled studies on pregnant women taking atorvastatin; however, there are occasional reports of congenital abnormalities in the fetus when exposed to statins in utero. Rat and rabbit breeding studies have not observed

Precautions for children: This product should only be used by specialists in children. The experience of this product in treating children is limited to a small number of cases (10 to 17 years old) of heterozygous familial hyperlipidemia. (See inner package insert for details) Precautions for pregnancy and lactation: Pregnancy category X prohibits pregnant women or women of childbearing age who may become pregnant from taking atorvastatin. In normal pregnancy, serum cholesterol and triglyceride levels in the body are elevated, and cholesterol or cholesterol derivatives are essential substances for fetal development. Atherosclerosis is a chronic disease process, so discontinuation of lipid-lowering drug treatment during pregnancy in patients with primary hypercholesterolemia has little effect on the long-term outcome of atherosclerotic disease. 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 the incidence of congenital anomalies. 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 was no difference in overall safety and effectiveness 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.

During statin therapy, co-administration with the following drugs may increase the risk of myopathy, such as: colchicine, combined use of HIV protease inhibitors, HCV protease inhibitors, azole antifungal drugs, macrolide antifungal drugs, fibrin derivatives, hydrochloric acid, nefazodone, cyclosporine, amiodarone, diltiazem, fudiciic acid, etc. (See [Precautions], "Skeletal Muscle" and [Pharmacology and Toxicology]). 1. Strong CYP3A4 inhibitors: Lipitor is metabolized by cytochrome P4503A4. The co-administration of Lipitor with strong CYP3A4 inhibitors can cause an increase in the plasma concentration of atorvastatin. The degree of drug interaction and the degree of effect enhancement depend on the degree of effect of different products on CYP3A4. 2. Clarithromycin: Compared with Lipitor alone,

Keep tightly closed.

20mg*7s

24 months

Lepu Pharmaceutical Technology Co., Ltd.

• Founded in:

  2016-12-29

• Address:

  No. 27 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province

• Tax NO.:

  91331002MA28HA6W85

• Registered Funds:

  100 million yuan

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