Item nanme:Atorvastatin calcium tablets Item character: This product is white.
Indication: Hypercholesterolemia Patients with primary hypercholesterolemia. If the curative effect of diet treatment and other non drug treatment is not satisfactory, the application of this product can treat the patients with familial hypercholesterolemia (heterozygous type) or mixed type hyperlipidemia (equivalent to type IIA and type IIB of Fredrickson classification) with elevated total cholesterol (TC), low density lipoprotein cholesterol (LDL-C) and apolipoprotein B (apo-c) B) And triglyceride (TG) increased. In homozygous familial hypercholesterolemia patients, atorvastatin can be used in combination with other lipid-lowering therapies (such as LDL plasma dialysis) or alone (when there is no other treatment) to reduce TC and LDL-C. coronary heart disease This product is suitable for patients with coronary heart disease or coronary heart disease and other critical diseases (such as diabetes, symptomatic atherosclerotic disease, etc.) complicated with hypercholesterolemia or mixed dyslipidemia. It is suitable for reducing the risk of non fatal myocardial infarction, fatal and non fatal stroke, vascular reconstruction, hospitalization due to congestive heart failure and reducing the risk of death The risk of angina.
Item specifications: 20mg*7tab/box
Usage and dosage:Before the treatment of this product, patients should have standard low cholesterol diet control, and maintain reasonable diet throughout the treatment period. The dose should be adjusted individually according to the baseline level of LDL cholesterol, treatment objectives and the therapeutic effect of the patients. The commonly used starting dose is 10mg, once a day. The dose adjustment interval should be 4 weeks or more. The maximum dose of this product is 80mg once a day. It can be taken at any time of the day and is not affected by the meal. The treatment objectives of low-risk patients with cardiovascular events were LDL-C < 4.14mmol/l (or < 160mg/dl) and total cholesterol < 6.62mmol/l (or < 240mg/dl). The treatment objectives of the patients at middle risk were LDL-C < 3.37mmol/l (or < 130mg / dl) and total cholesterol < 5.18mmol/l (or < 220mg/dl). The treatment objectives of high risk patients were LDL-C < 2.59mmol/l (or < 100mg / dl) and total cholesterol < 4.14mmol/l (or < 160mg/dl). The treatment objectives of patients with extreme high risk were LDL-C < 2.07mmol/l (or < 80mg/dl) and total cholesterol < 3.11mmol/l (or < 120mg/dl). It is from the Chinese Journal of cardiovascular disease, Vol. 35, No. 5, page 390-431, 2007, "guidelines for prevention and treatment of dyslipidemia in Chinese adults". Treatment of primary hypercholesterolemia and mixed hyperlipidemia Most patients take atorvastatin calcium once a day 10 mg, their blood lipid level can be controlled. The treatment of 2 weeks can be seen obvious curative effect, treatment within 4 weeks can be seen significant effect. Long term treatment can maintain the curative effect. Treatment of heterozygous familial hypercholesterolemia The initial dose of the patient was 10mg daily. The individualization principle of dose should be followed and the dosage should be adjusted gradually to 40 mg daily at 4 weeks interval. If the satisfactory effect is still not achieved, the dosage can be adjusted to the maximum dose of 80 mg daily or 40 mg of this product combined with AO mixture of cholic acid. Homozygous family hypercholesterolemia was studied in a charity drug use study of 64 patients, 46 of whom had LDL receptor information. LDL-C in 46 patients decreased by 21% on average. The dosage of this product can be increased to 80 mg / day. Treatment of homozygous familial hypercholesterolemia In a charity drug study of 64 patients, 46 had confirmed LDL receptor information. LDL-C in 46 patients decreased by 21% on average. The dosage of this product can be increased to 80mg/ day. For homozygous family hypercholesterolemia patients, the recommended dose of this product is 10-80 mg daily. Atorvastatin calcium should be used as an auxiliary treatment for other lipid lowering treatment measures (such as LDL plasma dialysis). Or when there is no such treatment conditions, the product can be used separately. Dosage of drug use in patients with renal dysfunction Kidney disease will not affect the plasma concentration of the product nor the effect of lipid lowering, so there is no need to adjust the dose.
Adverse reactions
The following serious adverse reactions are described in other parts of this manual; Rhabdomyolysis and myopathy (see Notes) Abnormal liver enzymes (see Notes) Clinical adverse reactions In the process of clinical trial, the patients' condition is complex, so the incidence of adverse reactions of two different drugs in clinical research can not be directly compared, and may not reflect the incidence of adverse reactions in clinical practice. A total of 16066 patients (Lipitor n = 8755, placebo n = 7311, aged from 10 to 93, 39% female; 91% Caucasian white, 3% black, 2% Asian, 4% other race) were enrolled in the Atorvastatin placebo-controlled clinical trial. The median treatment period was 53 weeks. Regardless of causality, 9.7% and 9.5% of the patients in the Atorvastatin group and the placebo group suffered from diabetes, respectively The drug was withdrawn due to adverse reactions. The five most common adverse reactions leading to drug withdrawal and the incidence of Lipitor group was higher than that of placebo group were myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), elevated ALT (0.4%) and elevated liver enzymes (0.4%). Regardless of causality, the most common adverse reactions (≥ 2%) in the Lipitor placebo-controlled trial (n = 8755) with a higher incidence than placebo were nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), limb pain (6.0%) and urinary tract infection (5.7%). Table 1 summarizes the adverse reactions (regardless of cause and effect) in 17 placebo-controlled trials with an incidence of ≥ 2% and higher than that in the placebo group in 8755 patients treated with Lipitor.
Taboo:
1. Active liver disease may include unexplained persistent elevation of liver transaminase 2. Allergy to any of the ingredients in this product is known. 3. Pregnancy This product is prohibited for pregnant women or women of childbearing age who may be pregnant. Pregnant women taking this product may cause damage to the fetus. The levels of serum cholesterol and triglyceride are increased in normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Atherosclerosis is a chronic process. Therefore, discontinuation of lipid-lowering drugs in patients with primary hypercholesterolemia during pregnancy has little effect on the long-term outcome of atherosclerosis. At present, there are not enough control studies on atorvastatin use in pregnant women; however, there are occasional reports of fetal congenital abnormalities after intrauterine exposure to statins. There was no evidence of teratogenicity of atorvastatin in rats and rabbits. For women of childbearing age, only those who are highly unlikely to conceive and have been informed of the potential hazards can be prescribed Lipitor. During pregnancy, the patient should stop taking the drug immediately, and consider the potential harm of the drug to the fetus (see medication for pregnant and lactating women). 4. Lactating women Whether atorvastatin can be secreted from human milk is unknown, but other drugs of this kind can be secreted into milk in small amount. Because statins may have potentially serious adverse reactions to newborns receiving breast-feeding, women taking statins are prohibited from breast-feeding (see medication for pregnant and lactating women).
Matters needing attention: 1. Skeletal muscle Atorvastatin and other statins occasionally cause myoglobinuria secondary to acute renal failure due to rhabdomyolysis. The history of renal damage may be a risk factor for rhabdomyolysis. The effect of drugs on skeletal muscle should be closely monitored in these patients. Like other statins, atorvastatin can cause myopathy (myopathy is defined as muscle pain or muscle weakness, accompanied by CPK more than 10 times of the upper limit of normal). High dose atorvastatin combined with specific drugs such as cyclosporine or strong CYP3A4 inhibitors such as clarithromycin, itraconazole and HIV protease inhibitors can increase the risk of myopathy or rhabdomyolysis. Any patient with diffuse myalgia, muscle tenderness or weakness, and / or significant elevation of creatine phosphokinase should be considered as myopathy. Patients should be advised to report unexplained muscle pain, tenderness or weakness immediately, especially when accompanied by discomfort or fever. Atorvastatin therapy should be discontinued if there is a significant increase in creatine phosphokinase level or if myopathy is diagnosed / suspected. If cyclosporine A, fibrin derivatives (beta drugs), erythromycin, clarithromycin, ritonavir plus saquinavir or lopinavir plus ritonavir, nicotinic acid or imidazole antifungal drugs are used simultaneously during the treatment, the risk of myopathy will be increased. Doctors are considering the combination of atorvastatin and fibric acid derivatives (beta drugs), erythromycin, clarithromycin, ritonavir plus saquinavir or lopinavir plus ritonavir, immunosuppressive drugs, imidazole antifungal drugs or lipid-lowering dosage During nicotinic acid treatment, the potential benefits and risks should be carefully weighed, and any signs and symptoms of muscle pain, tenderness or weakness should be carefully monitored, especially in the first few months of treatment and during the up regulation of any drug dose. When atorvastatin is used in combination with the drugs mentioned above (see drug interaction), the initial dose and maintenance dose of atorvastatin should be reduced. In this case, regular measurement of creatine phosphokinase should be considered, but such monitoring can not ensure the prevention of serious myopathy. The recommended prescription dosage and drug interactions are summarized in Table 2 (see [usage and dosage], [drug interactions], [pharmacology and toxicology] for details).
Medication for pregnant and lactating women: gestation The serum cholesterol and triglyceride levels in body increased in normal pregnancy status of pregnancy classification x, while cholesterol or cholesterol derivatives are essential substances for fetal development. Atherosclerosis is a chronic disease process, so the discontinuation of lipid lowering drugs in patients with primary hypercholesterolemia has little effect on the long-term outcome of atherosclerosis. There is no sufficient control study on Lipitor in pregnancy. Rare reports of congenital abnormalities caused by intrauterine exposure to statins. A follow-up study of pregnant women who exposed to other statins showed that the incidence of congenital abnormalities, spontaneous abortions and fetal deaths / stillbirths did not exceed the expected value of the general population. However, this study could only exclude the risk of 3-4 times the incidence rate of congenital anomalies, while 89% of patients began to take drugs before pregnancy, but were informed that they stopped taking drugs within 3 months after pregnancy. Atorvastatin reached the same drug level as maternal plasma in fetal liver through the placenta of rats. When the dose of rats was up to 300mg/kg/ day and rabbit dose was 100mg/kg/ day, atorvastatin had no teratogenic effect. Surface area of body (mg/m2) These doses are calculated to be about 30 times (rats) or 20 times (rabbits) of human exposure (see contraindications, pregnancy). In one study, rats were given 20100, or 225mg/kg/ day, from day 7 of pregnancy to day 21 of lactation (weaning), and the survival rate of the infant at birth, newborn, weaning and maturity decreased at 225mg/kg/ day. The dosage of the mother was 100mg/kg/ day, the weight of the infant on the 4th and 21st days decreased; the dosage of the mother was 225mg/kg/ day at birth, the weight of the infant on the 4th, 21st and 91 days decreased; the development of the young animals was delayed (the dosage was 100 mg/kg/ day, and the ralette syndrome appeared at the dose of 100 mg/kg/ day, and the auditory shock response occurred at 225 mg/kg/ day; the dose was 225mg/kg/ day with auricle separation and eye fissure). These doses are 6 times (100mg/kg/ day) and 22 times (225mg/kg/ day) of the area under the curve when taking 80mg daily. Statins may harm the fetus when given to pregnant women. Women of childbearing age can only take this product if they are very likely to conceive and have been told of the potential risks of the drug to pregnant women. Once pregnant, women taking this product should stop the drug immediately and inform of the potential risk to the fetus, and continue to use the drug during pregnancy lacks known clinical benefits. Lactating women Whether atorvastatin is secreted through human milk is unclear, but another drug of the same kind can be secreted into milk in small quantities. The plasma and liver concentrations of atorvastatin in the lactated young rats were 50% and 40% of the drug concentration in breast milk, respectively. The concentration level of animal milk may not accurately reflect the concentration level of human milk drug, because another similar drug can be secreted through human milk, while statins may cause serious adverse reactions to the newborn receiving lactation, so mothers taking this product should not breastfed (see [taboo].
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