| Generic Name |
Atorvastatin Calcium Tablets |
| Strength |
20mg |
| Packing |
10 Tablets/box |
| Origin |
China |
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Product name:
Atorvastatin Calcium Tablets
Character:
This product is white.
Indications:
This product is white film coating, remove the film will appear white.
Adverse reactions:
hypercholesterolemia
Patients with primary hypercholesterolemia. Including patients with familial hypercholesterolemia (heterozygous type) or mixed hyperlipidemia (Fredrickson equivalent to types IIa and IIb), if the response to dietary therapy and other non-pharmacological treatments is unsatisfactory, It can be used to treat elevated total cholesterol (TC), elevated low density lipoprotein cholesterol (LDL-C), elevated apolipoprotein B(Apo B) and elevated triglycerides (TG).
In patients with homozygous familial hypercholesterolemia, atorvastatin may be used in combination with other lipid-lowering therapies (such as LDL plasma dialysis) or alone (when no other treatment is available) to lower TC and LDL-C.
Coronary heart disease
For patients with coronary heart disease or coronary heart disease and other dangerous diseases (such as diabetes, symptomatic atherosclerotic diseases, etc.) combined with hypercholesterolemia or mixed dyslipidemia, this product is suitable for: Lower the risk of non-fatal myocardial infarction, lower the risk of fatal and non-fatal stroke, lower the risk of revascularization, lower the risk of hospitalization for congestive heart failure, lower the risk of angina pectoris.
Pharmacology and toxicology:
Clinical pharmacology
Action mechanism
Atorvastatin is a selective and competitive inhibitor of HMG-CoA reductase. HMG-CoA's role is to convert hydroxymethylglutarate monoyl CoA into mevalonate, A precursor of sterols including cholesterol. Clinical, pathological and epidemiological studies have shown that elevated plasma levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B(apo B) promote atherosclerosis and are risk factors for cardiovascular disease, while elevated HDL cholesterol levels are associated with a reduced risk of cardiovascular disease.
In animal models, atorvastatin reduces plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA reductase and cholesterol synthesis in the liver, and enhances low-density lipoprotein uptake and catabolism by increasing the number of LDL receptors on the surface of liver cells. Lipitor also reduced LDL production and LDL particle count. Lipitor can reduce LDL cholesterol levels in some homozygous familial hypercholesterolemia (FH) patients, who usually have little clinical benefit from other lipid-lowering drugs.
Atorvastatin decreased total cholesterol, low density lipoprotein cholesterol, and apolipoprotein B levels in homozygous and heterozygous predisposition familial hypercholesterolemia, nonfamilial hypercholesterolemia, and mixed dyslipidemia. Atorvastatin also reduced very low density lipoprotein cholesterol and triglyceride levels, and increased HDL cholesterol and apolipoprotein A-1 levels. Atorvastatin reduced total cholesterol, low-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol in patients with pure hypertriglyceridemia, and increased HDL cholesterol levels. Atorvastatin reduces intermediate density lipoprotein cholesterol in patients with B lipoprotein dysplasia.
pharmacodynamics
Atorvastatin and some of its metabolites have pharmacological activity in human body. Liver is the basic action site and main site of cholesterol synthesis and low density lipoprotein clearance. Dose, rather than systemic drug concentration, was more associated with LDL cholesterol reduction. The individual dose should be based on the efficacy of the treatment (see Usage and dosage).
Non-clinical toxicology
Carcinogenesis, teratogenesis, reproductive damage
In a 2-year study conducted in rats, administered at dose levels of 10,30, and 100mg/kg/ day, 2 rare tumors were found in the muscle of female rats at high doses: one was rhabdomyosarcoma and the other was fibrosarcoma. This dose shows an area under the plasma curve (0-24) value about 16 times the average human plasma drug exposure after a maximum oral dose of 80mg.
In a 2-year carcinogenicity study in mice, doses of 100,200, or 400mg/kg/ day resulted in a significant increase in liver adenomas in high-dose male mice and liver cancer in high-dose female mice. These findings occurred at an area under the plasma curve (0-24) value about 6 times the average plasma drug concentration after human exposure to an oral dose of 80mg.
In vitro studies, atorvastatin was not mutagenic or teratogenic in the following experiments with or without metabolic activity: Ames assay with Salmonella Typhimurium and Escherichia coli; HGPRT mutation-promoting assays in Chinese hamster lung cells; and chromosomal aberration assays in Chinese hamster lung cells. Atorvastatin was negative in micronucleus tests in mice.
In studies conducted in rats at doses up to 175mg/kg/ day (15 times the human exposure), atorvastatin did not have any effect on the animals' fertility. Ten rats were given atorvastatin 100 mg/kg/ day (16 times the area under the curve when given 80mg in humans) for 3 months, and two of them had epididymal dysplasia and anspermatosis. Testicular weight decreased significantly in the 30 and 100mg/kg/ day dose groups, and epididymal weight decreased in the 100mg dose group. Male rats given atorvastatin 100mg/kg/ day before mating for 11 weeks experienced a decrease in sperm motility and head concentration of sperm cells, while malformation sperm increased. In dogs administered 10,40, or 120mg/kg/ day of atorvastatin for two years, there were no adverse effects on semen parameters or reproductive organ histopathology.
Storage:
Keep out of light and sealed.
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