Concise Prescribing Info
Adjunct to diet for patients w/ elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B (apo B) & triglycerides & to increase HDL-cholesterol (HDL-C) in patients w/ primary hypercholesterolemia (heterozygous familial & non-familial), combined (mixed) hyperlipidemia, elevated serum triglyceride levels & for patients w/ dysbetalipoproteinemia who do not respond adequately to diet. Reduction of total-C & LDL-C in patients w/ homozygous familial hypercholesterolemia. Prevention of CV disease w/o clinically evident CHD but w/ multiple risk factors eg, age, smoking, HTN, low HDL-C or family history of early CHD for reduction of risk of MI, stroke, revascularisation procedures & angina. In type 2 diabetes w/o clinically evident CHD but w/ multiple risk factors eg, retinopathy, albuminuria, smoking or HTN for reduction of risk of MI & stroke. In patients w/ clinically evident CHD for reduction of risk of non-fatal MI, fatal & non-fatal stroke, angina, revascularisation procedures & hospitalisation for CHF. Adjunct to diet to reduce total-C, LDL-C & apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if LDL-C ≤190 mg/dL or ≥160 mg/dL & there is a positive family history of premature CV disease or ≥2 other CV disease risk factors remains after adequate diet therapy.
Dosage/Direction for Use
Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia Most patient responded to 80 mg once daily. Heterozygous familial hypercholesterolemia in ped patient (10-17 yr) Initially 10 mg daily, dose adjustments made at ≥4 wk intervals. Max: 20 mg daily. Childn Homozygous familial hypercholesterolemia Up to 80 mg daily.
May be taken with or without food: Avoid excessive consumption (>1.2 L daily) of grapefruit juice.
Hypersensitivity. Active liver disease or unexplained persistent elevated serum transaminases >3 times upper limit of normal. Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
Special Precautions
Discontinue use if markedly elevated creatine phosphokinase levels occur or myopathy is diagnosed or suspected. Immune-mediated necrotizing myopathy. Increased risk for recurrent hemorrhagic stroke. Temporarily withheld or discontinue in acute, serious condition suggestive of myopathy or risk factor predisposing to renal failure secondary to rhabdomyolysis development eg, severe acute infection; hypotension; major surgery, trauma; severe metabolic, endocrine & electrolyte disorders; uncontrolled seizures. Perform liver function tests prior to & periodically thereafter. Substantial alcohol consumption &/or history of liver disease. Concurrent use w/ cyclosporine, fibric acid derivatives, erythromycin, niacin, azole antifungals or certain PIs. Women of childbearing potential should use effective contraception.
Adverse Reactions
Nasopharyngitis; hyperglycemia; pharyngolaryngeal pain, epistaxis; nausea, diarrhea, dyspepsia, flatulence; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; abnormal liver function test, increased blood creatine phosphokinase.
Drug Interactions
Increased risk of myopathy w/ cyclosporine, fibric acid derivatives, niacin, erythromycin, azole antifungals. Increased plasma conc by CYP450 3A4 inhibitors, erythromycin/clarithromycin, PIs, diltiazem, grapefruit juice. Reduced plasma conc by CYP450 3A4 inducers eg, efavirenz, rifampin; Mg- & Al hydroxide-containing antacids, colestipol. Increased digoxin conc. Increased AUC values for norethindrone & ethinyl estradiol.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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