INDICATIONS AND USAGE

LIPITOR is an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to:

• Reduce the risk of MI, stroke, revascularization procedures, and angina in patients without CHD, but with multiple risk factors (1.1).
• Reduce the risk of MI and stroke in patients with type 2 diabetes without CHD, but with multiple risk factors (1.1).
• Reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for CHF, and angina in patients with CHD (1.1).
• Reduce elevated total-C, LDL-C, apo B, and TG levels and increase HDL-C in adult patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (1.2).
• Reduce elevated TG in patients with hypertriglyceridemia and primary dysbetalipoproteinemia (1.2).
• Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) (1.2).
• Reduce elevated total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy (1.2).

Limitations of Use

LIPITOR has not been studied in Fredrickson Types I and V dyslipidemias.

DOSAGE AND ADMINISTRATION

Dose range: 10 to 80 mg once daily (2.1).

Recommended start dose: 10 or 20 mg once daily (2.1).

Patients requiring large LDL-C reduction (>45%) may start at 40 mg once daily (2.1).

Pediatric starting dose: 10 mg once daily; maximum recommended dose: 20 mg once daily (2.2).

DOSAGE FORMS AND STRENGTHS

10, 20, 40, and 80 mg tablets (3).

CONTRAINDICATIONS

Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels (4.1).

Women who are pregnant or may become pregnant (4.3).

Nursing mothers (4.4).

Hypersensitivity to any component of this medication (4.2).

WARNINGS AND PRECAUTIONS

Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase when higher doses are used concomitantly with cyclosporine, fibrates, and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, HIV protease inhibitors). Predisposing factors include advanced age (> 65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued (5.1).

Liver enzyme abnormalities and monitoring: Persistent elevations in hepatic transaminases can occur. Monitor liver enzymes before and during treatment (5.2).

A higher incidence of hemorrhagic stroke was seen in patients without CHD but with stroke or TIA within the previous 6 months in the LIPITOR 80 mg group vs. placebo (5.5).

ADVERSE REACTIONS

The most commonly reported adverse reactions (incidence ≥ 2%) in patients treated with LIPITOR in placebo-controlled trials regardless of causality were: nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at (1-800-438-1985 and www.pfizer.com) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Digoxin: Patients should be monitored appropriately (7.5).
• Oral Contraceptives: Values for norethindrone and ethinyl estradiol may be increased (7.6).
• Rifampin should be simultaneously co-administered with LIPITOR (7.4).

USE IN SPECIFIC POPULATIONS

• Hepatic impairment: Plasma concentrations markedly increased in patients with chronic alcoholic liver disease (12.3).