Regulatory Class: ℞

Generic Name: Atorvastatin

Formulation: 20mg, 40mg, 80mg tablet

Indications or Uses: Reduce LDL or bad cholesterol, apolipoprotein B & triglycerides. Increase HDL or good cholesterol in the treatment of hyperlipidemia including hypercholesterolemia & combined (mixed) hyperlipidemia (type IIa & IIb hyperlipoproteinemia), hypertriglyceridemia (type IV) & dysbetalipoproteinemia (type III). Adjunctive therapy in patients with homozygous familial hypercholesterolemia who have LDL-receptor function.

Dosage and Directions for Use: Primary hypercholesterolemia & combined (mixed) dyslipidemia including familial combined hyperlipidemia Starting dose: 10 or 20 mg. Patients requiring large reduction in LDL-cholesterol (>45%) Start at 40 mg. Dose range: 10-80 mg. Adjust dose at intervals of 2-4 wk up to a max of 80 mg/day. Severe dyslipidemia including homozygous & heterozygous familial hypercholesterolemia & dysbetalipoproteinemia (type III) Up to 80 mg/day. Heterozygous familial hypercholesterolemia Childn 10-17 yr Starting dose: 10 mg. Max: 20 mg/day. Adjust dose at intervals of ≥4 wk. Primary prevention of MI 10 mg. Secondary prevention of MI 10-80 mg. All doses to be taken once daily.

Administration: Take with or without food. Avoid excessive consumption (>1 L/day) of grapefruit juice.

Contraindication: Active liver disease or unexplained persistent elevations of serum transaminases >3x ULN. Pregnancy & lactation.

Special Precaution: Monitor lipid levels periodically. Discontinue use if markedly elevated creatine kinase levels & hypersensitivity occurs, if myopathy is diagnosed or suspected, during fusidic acid therapy & having risk factor predisposing to development of renal failure secondary to rhabdomyolysis. Patients w/ predisposing factors for myopathy/rhabdomyolysis. Concomitant use w/ CYP3A4 inhibitors; digoxin; drugs that may decrease endogenous steroid hormone levels (eg, ketoconazole, spironolactone, cimetidine). Consider risk of hemorrhagic stroke prior to treatment in patients w/ recent (1-6 mth) stroke or transient ischemic attack. Decrease in myocardial ubiquinone (CoQ10) levels may lead to impaired cardiac function in CHF patients. Severe renal impairment. Perform liver function test prior to treatment & periodically thereafter. Ped patients except childn 10-17 yr w/ heterozygous familial hypercholesterolemia. Elderly ≥70 yr.

Adverse Reaction: Diarrhea, dyspepsia, nausea, constipation, flatulence; asthenia; nasopharyngitis; abnormal liver function test, increased blood creatine phosphokinase, hyperglycemia; arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling; headache; pharyngolaryngeal pain, epistaxis.

Interactions: CYP3A4 inhibitors eg, grapefruit juice, fibric acid derivatives (gemfibrozil, fenofibrate, other fibrates, niacin), macrolides (erythromycin, clarithromycin), immunosuppressants (cyclosporine), azole antifungals (itraconazole, ketoconazole), PIs (nelfinavir, lopinavir, ritonavir, saquinavir), antidepressants, nefazodone; CYP3A4 inducers eg, efavirenz, rifampin; colestipol; digoxin; OCs & hormone replacement therapy eg, norethindone, ethinylestradiol; Al- & Mg-containing antacids; diltiazem; fusidic acid.

Presentation/Packaging: Film Coated tablet 20 mg x 10's, 100's. 40 mg x 10's, 100's. 80 mg x 10's, 100's.

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