| Dossier: | Ctd |
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| Transport Package: | Free |
| Specification: | 20mg |
| Trademark: | Sinolead |
| Origin: | China |
| Samples: |
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| Customization: |
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| Generic Name | Atorvastatin Calclum Tablets 20mg |
| Strength | 20mg |
| Packing | 10 tablets/box |
| Origin | China |
This product is white film coating, remove the film will appear white.
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.
Patients should be on a standard low cholesterol diet before starting treatment with this product and should maintain a reasonable diet throughout treatment. Individual dose adjustments should be made based on baseline LDL cholesterol levels, treatment goals, and patient outcomes.
The usual starting dose is 10mg once daily. The dose adjustment interval should be 4 weeks or longer. The maximum dose of this product is 80mg once daily. It can be taken at any time of the day and is not affected by meals.
For low-risk patients with cardiovascular events, the treatment target is LDL-C< 4.14mmol/L(or < 160mg/dL) and total cholesterol 6.62mmol/L(or < 240mg/dL). The target of treatment for middle-risk patients is LDL-C< 3.37mmol/L(or < 130mg/dL) and total cholesterol < 5.18mmol/L(or < 220mg/dL). The treatment target of high-risk patients is LDL-C< 2.59mmol/L(or < 100mg/dL) and total cholesterol 4.14mmol/L(or < 160mg/dL). The treatment target for extremely high-risk patients is LDL-C< 2.07mmol/L(or < 80mg/dL) and total cholesterol < 3.11mmol/L(or < 120mg/dL).
Excerpt from "Guidelines for the Prevention and Treatment of dyslipidemia in Chinese adults", Chinese Journal of Cardiovascular Diseases, Vol. 35, No. 5, 2007, pp. 390-431.
Treatment of primary hypercholesterolemia and mixed hyperlipidemia
Most patients take atorvastatin calcium 10 mg once daily and their lipid levels can be controlled. Significant curative effect was observed within 2 weeks of treatment and within 4 weeks of treatment. Long-term treatment can maintain the curative effect.
Treatment of heterozygous familial hypercholesterolemia
The initial dose for patients is 10mg daily. The principle of dose individualization should be followed and the dose should be gradually adjusted to 40 mg daily every 4 weeks at a time interval. If satisfactory efficacy is still not achieved, the dose may be adjusted to the maximum dose of 80 mg daily or 40 mg of this product combined with cholic acid chelator treatment. Homozygous familial hypercholesterolemia In a charitable medication study of 64 patients, 46 of whom had corresponding LDL receptor information. The 46 patients had an average 21 percent reduction in LDL-C. The dosage of this product can be increased to 80 mg daily.
Treatment of homozygous familial hypercholesterolemia
In a charitable drug use study of 64 patients, 46 had confirmed LDL receptor information. The 46 patients had an average 21 percent reduction in LDL-C. The dosage of this product can be increased to 80mg/ day.
The recommended dose for homozygous familial hypercholesterolemia is 10-80 mg daily. Atorvastatin calcium should be used as an adjunct to other lipid-lowering treatments, such as LDL plasma dialysis. Or when these treatment conditions are not available, this product can be used alone.
Dosage for patients with renal insufficiency
Kidney disease does not affect the plasma concentration of this product, nor does it affect its lipid-lowering effect, so there is no need to adjust the dose.
Matters needing attention:
1. Skeletal muscle
Atorvastatin and other statins have occasionally been reported in a few cases of acute renal failure secondary to rhabdomyolysis and myoglobinuria. A history of renal damage may be a risk factor for rhabdomyolysis, and these patients need to be closely monitored for skeletal muscle effects.
As with other statins, atorvastatin can occasionally cause myopathy (defined as muscle pain or muscle weakness accompanied by creatine phosphokinase CPK more than 10 times the upper limit of normal). High doses of atorvastatin combined with certain drugs such as cyclosporine or CYP3A4 suppressants such as clarithromycin, itraconazole, and HIV protease inhibitors may increase the risk of myopathy or rhabdomyolysis.
Patients with any diffuse myalgia, muscle tenderness or weakness, and/or significant creatine phosphokinase elevation should be considered for myopathy. Patients should be advised to immediately report unexplained muscle pain, muscle tenderness, or muscle weakness, especially if accompanied by discomfort or fever. Atorvastatin therapy should be discontinued if there is a significant increase in creatine phosphokinase levels or if myopathy is confirmed/suspected.
The combined use of cyclosporine A, fibrinic acid derivatives (Bates), erythromycin, clarithromycin, ritonavir Gaz quinavir or lopinavir galitonavir, niacin or imidazole antifungals during treatment with this class of drugs increases the risk of myosis. Physicians should carefully weigh the potential benefits and risks when considering treatment with atorvastatin in combination with fibrate derivatives (Bates), erythromycin, clarithromycin, ritonavir, quinavir or lopinavir in combination with tonavir, immunosuppressants, imidazole antifungals, or niacin at lipid-regulated doses. Patients should also be carefully monitored for any signs and symptoms of muscle pain, muscle tenderness, or muscle weakness, especially during the first few months of treatment and during updosing of any of the drugs. When atorvastatin is administered in conjunction with the previously mentioned drugs (see Drug Interactions), consideration should be given to reducing the initial and maintenance doses of atorvastatin. In this case, periodic creatine phosphokinase assay should be considered, but such monitoring does not ensure prevention of severe myopathy.
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