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LIPITOR
Hyperlipoproteinemias
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Drug Name:

LIPITOR Rx

Generic Name and Formulations:
Atorvastatin (as calcium) 10mg, 20mg, 40mg, 80mg; tabs.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for LIPITOR:

Adjunct to diet in primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Types IIa and IIb) to reduce total-C, LDL-C, apo B and TG, and to increase HDL-C. Adjunct to diet in treating elevated serum TG (Type IV). Treatment of primary dysbetalipoproteinemia (Type III) not adequately responsive to diet. Adjunct to other lipid-lowering treatments (or when these are unavailable), in homozygous familial hypercholesterolemia to reduce total-C and LDL-C. Adjunct to diet to reduce total-C, LDL-C and apo B in patients 10–17 years of age (≥1 year post-menarche) with heterozygous familial hypercholesterolemia if LDL-C remains ≥190mg/dL, or if LDL-C remains ≥160mg/dL with either family history of premature cardiovascular disease (CVD) or if patient has at least 2 other CVD risk factors. To reduce risk of MI, stroke, and risk of revascularization procedures in adults at risk (see full labeling). To reduce risk of MI and stroke in patients with type 2 diabetes and at risk (see full labeling). To reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization, hospitalization for CHF, and angina in patients with clinically evident coronary heart disease. Limitations of use: not studied where major abnormality is elevation of chylomicrons (Fredrickson Types I and V).

Adult:

≥17yrs: Heterozygous and Types IIa and IIb: initially 10 or 20mg once daily; if more than a 45% reduction in LDL-C is needed, may start at 40mg once daily; range 10–80mg once daily. Homozygous: 10–80mg daily. Concomitant clarithromycin, itraconazole, saquinavir + ritonavir, darunavir + ritonavir, fosamprenavir or fosamprenavir + ritonavir: max 20mg/day. Concomitant nelfinavir or boceprevir: max 40mg/day.

Children:

Heterozygous: <10yrs: not established. 10–17yrs: initially 10mg/day, may increase to 20mg/day after at least 4 weeks. Homozygous: 80mg/day has been used (see full labeling).

Contraindications:

Active liver disease. Unexplained persistent elevated serum transaminases. Pregnancy. Nursing mothers.

Warnings/Precautions:

Discontinue if myopathy or elevated CPK levels occur. Suspend in any patient with acute condition suggestive of myopathy, or if predisposed to development of renal failure secondary to rhabdomyolysis. Monitor liver function before starting therapy and repeat as clinically indicated. History of liver disease. Substantial alcohol ingestion. Recent stroke or TIA: increased risk of hemorrhagic stroke. Elderly.

Pharmacological Class:

HMG-CoA reductase inhibitor.

Interactions:

See Adult dose. Avoid with concomitant cyclosporine, gemfibrozil, tipranavir + ritonavir, telaprevir. Potentiated by strong CYP3A4 inhibitors, grapefruit juice (>1.2L/day). Caution with lopinavir + ritonavir, other fibrates, niacin (≥1g/day), colchicine; consider dose reduction of atorvastatin. May increase serum levels of digoxin, oral contraceptives (norethindrone, ethinyl estradiol); monitor digoxin. May be antagonized by CYP3A4 inducers (eg, efavirenz, rifampin); must co-administer atorvastatin simultaneously with rifampin. Caution with concomitant drugs that may decrease levels or activity of steroid hormones (eg, ketoconazole, spironolactone, cimetidine).

Adverse Reactions:

Nasopharyngitis, arthralgia, diarrhea, pain in extremity, UTI; rhabdomyolysis with renal failure, myopathy, elevated serum transaminases, increased HbA1c and fasting serum glucose, cognitive impairment; rare: immune-mediated necrotizing myopathy.

How Supplied:

Tabs 10mg, 20mg—90, 1000, 5000; 40mg, 80mg—90, 500, 2500


Data provided by MPR.

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