LIPITOR® (AVORVASTATIN CALCIUM) (Pfizer)

LIPITOR^® (atorvastatin calcium) is indicated to reduce the risk of myocardial infarction, revascularization procedures, and angina in adult patients with multiple risk factors but without clinically evident CHD; as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels; and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

LIPITOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases; in women who are or may become pregnant or who are nursing; in patients with hypersensitivity to any component of this medication.

Rare cases of rhabdomyolysis have been reported with LIPITOR and other statins. With any statin, tell patients to promptly report muscle pain, tenderness, or weakness. Discontinue drug if myopathy is suspected, if creatine phosphokinase (CPK) levels rise markedly, or if the patient has risk factors for rhabdomyolysis.

Due to increased risk of myopathy seen with LIPITOR and other statins, physicians should carefully consider combined therapy with fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals, or niacin and carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating dose of either drug.

It is recommended that liver function tests be performed prior to and 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter. If ALT or AST values >3 x ULN persist, dose reduction or withdrawal is recommended.

In clinical trials, the most common adverse events were constipation, flatulence, dyspepsia, and abdominal pain. ...  more from www.lipitor.com (a Pfizer website)