Pravachol

[Pravastatin]

Gastrointestinal

pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaun-dice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma.

Dermatologic

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A variety of skin changes (e. g., nodules, discoloration, dryness of mucous membranes, changes to hair/ nails).

Reproductive

gynecomastia.

Laboratory Abnormalities

elevated alkaline phosphatase and bilirubin; thyroid function abnormalities.

Laboratory Test Abnormalities Increases in serum transaminase (ALT, AST) values and CPK have been observed (see WARNINGS). Transient, asymptomatic eosinophilia has been reported. Eosinophil counts usually returned to normal despite continued therapy. Anemia, thrombocytopenia, and leukopenia have been reported with HMG-CoA reductase inhibitors.

Concomitant Therapy

Pravastatin has been administered concurrently with cholestyramine, colestipol, nicotinic acid, probucol and gemfibrozil. Preliminary data suggest that the addition of either probucol or gemfibrozil to therapy with lovastatin or pravastatin is not associated with greater reduction in LDL-cholesterol than that achieved with lovastatin or pravastatin alone. No adverse reactions unique to the combination or in addition to those previously reported for each drug alone have been reported. Myopathy and rhabdomyolysis (with or without acute renal failure) have been reported when another HMG-CoA reductase inhibitor was used in combination with immunosuppressive drugs, gemfibrozil, erythromycin, or lipid-lowering doses of nicotinic acid. Concomitant therapy with HMG-CoA reductase inhibitors and these agents is generally not recommended. (See WARNINGS: Skeletal Muscle and PRECAUTIONS: Drug Interactions.)

Pediatric Patients

In a two year double-blind placebo-controlled study involving 100 boys and 114 girls with HeFH, the safety and tolerability profile of pravastatin was generally similar to that of placebo. (See CLINICAL PHARMACOLOGY, Pediatric Clinical Study and PRECAUTIONS, Pediatric Use.)

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