Prime Pharmaceuticals


AGlobal Care
Concise Prescribing Info
Atorvastatin Ca
Reduction of total cholesterol & LDL cholesterol in patients w/ homozygous familial hypercholesterolemia when responses to diet & other nonpharmacological measures are inadequate. Prevention of CV disease. Adult patient w/o clinically evident CHD eg, age, smoking, HTN, low HDL cholesterol or a family history of early heart disease to reduce the risk of: MI, stroke, for revascularization procedures & angina. In patients w/ type 2 diabetes & w/o clinically evident CHD but w/ multiple risk factors for CHD eg, retinopathy, albuminuria, smoking or HTN to reduce the risk MI & stroke.
Dosage/Direction for Use
10-80 mg once daily. Starting & maintenance dose: Individualized dosage. After initiation &/or titration, lipid levels should be analyzed w/in 2-4 wk. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once a day. Homozygous familial hypercholesterolemia 10 mg w/ >15% reduction in LDL-C (18%-45%).
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Hypersensitivity. Active liver disease or unexplained persistent serum transaminases elevation >3x ULN. Women who may become pregnant. Pregnancy & lactation.
Special Precautions
Patients who consume substantial quantities of alcohol, renal or hepatic impairment/failure & w/ hypothyroidism. Elevation in transaminases. Elderly ≥65 yr.
Adverse Reactions
Headache, nausea, diarrhea, abdominal pain, dyspepsia, constipation, flatulence. Rhabdomyolysis, arthralgia, rupture of tendon; elevated liver enzyme, liver failure; systemic lupus erythematosus; hemorrhagic cerebral infarction; dermatomyositis.
Drug Interactions
Increased risk of myopathy w/ fibric acid & derivatives, lipid-modifying doses of niacin, cyclosporine or strong CYP3A4; other fibrates; colchicine. Increased AUC w/ clarithromycin; HIV-PIs (lopinavir, ritonavir, saquinavir, darunavir, fosamprenavir, tipranavir) & hepatitis C-PIs (telaprevir); itraconazole; OCs (norethindrone & ethinyl estradiol). Increased plasma conc w/ excessive grapefruit juice (>1.2 L/day). Increased bioavailability w/ OATP181 inhibitors (eg, cyclosporine). Increased risk of myopathy/rhabdomyolysis w/ gemfibrozil. May enhance risk of skeletal muscle effects w/ niacin. Reduced plasma conc w/ CYP450 3A4 (eg, efavirenz, rifampin). May increase plasma conc of digoxin.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
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