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Contents: Atorvastatin calcium.
Indications: As an adjunct to diet for the treatment of patients w/ elevated total & LDL cholesterol, apolipoprotein B & triglycerides & to increase HDL-cholesterol in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial hypercholesterolemia), combined (mixed) hyperlipidemia (Fredrickson types IIa & IIb), elevated serum triglyceride levels (Fredrickson type IV) & for patients w/ dysbetalipoproteinemia (Fredrickson type III) who do not respond adequately to diet. Reduction of total & LDL-cholesterol in patients w/ homozygous familial hypercholesterolaemia. Reduction of total & LDL cholesterol & apolipoprotein B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia when after adequate diet therapy, LDL cholesterol remains ≥190 mg/dL or ≥160 mg/dL & there is a +ve family history of premature CV disease or ≥2 other CV disease risk factors. Prevention of CV disease w/o clinically evident coronary heart disease but w/ multiple risk factors eg, age, smoking, HTN, low HDL-C, or family history of early CHD for reduction of the risk of MI, stroke & revascularisation procedures & angina. In type 2 diabetes w/o clinically evident CHD but w/ multiple risk factors e,. retinopathy, albuminuria, smoking or HTN for reduction of the risk of MI & stroke. In patients w/ clinically evident CHD for reduction of the risk of non-fatal MI, fatal & non-fatal stroke, revascularisation procedures, hospitalisation for CHF & angina.
Dosage: Dose range: 10-80 mg once daily. Starting & maintenance dose should be individualised according to baseline LDL-cholesterol levels, the goal of therapy & patient response.
Administration: May be taken with or without food.
Contraindication: Hypersensitivity to atorvastatin. Active liver disease or elevated serum transaminases >3 times the upper limit of normal. Women w/ childbearing potential. Pregnancy & lactation.
Special Precautions: Monitor for creatine phosphokinase & transaminase elevations; hemorrhagic stroke; endocrine dysfunction. Avoid alcohol consumption.
Adverse Drug Reaction: Nasopharyngitis, hyperglycemia, pharyngolaryngeal pain, epistaxis, diarrhea, dyspepsia, nausea, flatulence, arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling, abnormal liver function test, increased blood creatine phosphokinase.
Pregnancy Category: X
Regulatory Category: B