Not to be given in patients w/ severe hepatic impairment or significant liver disease, gallstones or gallbladder disorders or hypoalbuminaemic states eg, nephrotic syndrome. Secondary causes of hyperlipidaemia. Reversible elevations in serum creatinine during monotherapy or when co-administered w/ statins. Interrupt treatment when creatinine level is 50% above ULN; measure creatinine during the 1st 3 mth after initiation of treatment & periodically thereafter. Monitor transaminase levels every 3 mth during the 1st 12 mth of treatment & periodically thereafter. Discontinue therapy if AST (SGOT) & ALT (SGPT) levels increase to >3 times the ULN range; symptoms indicative of hepatitis occur (eg, jaundice, pruritus) & diagnosis is confirmed by lab testing. Pancreatitis. Muscle toxicity, including rhabdomyolysis (very rare case), w/ or w/o renal failure. Co-administration w/ another fibrate or an HMG-CoA reductase inhibitor may increase risk of muscle toxicity, especially in cases of preexisting muscular disease. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Mild to moderate renal insufficiency. Do not administer during pregnancy & lactation.
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