Omnipix 135 Special Precautions

Hepatic transaminases can become significantly elevated (dose-related); hepatocellular, chronic active, and cholestatic hepatitis have been reported after weeks to several years of therapy. Baseline and regular monitoring of liver function tests is required; discontinue therapy in patients whose enzyme levels persist above 3 times the upper limit of normal.
Use with caution in patients with mild to moderate renal impairment; monitoring renal function in patients with renal impairment and consider monitoring patients with increased risk for developing renal impairment (eg, elderly and patients with diabetes).
Therapy should be discontinued in patients who develop markedly elevated creatine phosphokinase (CPK) concentrations or if myopathy/myositis is suspected or diagnosed.
In patients with severe hypertriglyceridemia, the occurrence of pancreatitis may represent a failure of efficacy, a direct effect of the drug, or obstruction of the common bile duct due to biliary tract stone or sludge formation.