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Fenofibrate Capsules Generic Name & Formulations
Legal Class
Rx
General Description
Fenofibrate 67mg, 134mg, 200mg; caps (micronized).
Pharmacological Class
Fibrate.
See Also
How Supplied
Contact supplier
Manufacturer
Fenofibrate Capsules Indications
Indications
Adjunct to diet: in severe hypertriglyceridemia; and to reduce elevated total-C, LDL-C, ApoB, and TG, and to increase HDL-C in primary hyperlipidemia and mixed dyslipidemia.
Fenofibrate Capsules Dosage and Administration
Adult
Take with food. Hypertriglyceridemia: 67–200mg/day; adjust in 4–8 week intervals; max 200mg/day. Hypercholesterolemia, dyslipidemia: 200mg/day. Renal impairment (CrCl<50mL/min): initially 67mg/day. Discontinue if inadequate response after 2 months on max dose.
Children
Not established.
Fenofibrate Capsules Contraindications
Contraindications
Severe renal impairment. Dialysis. Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver dysfunction. Gallbladder disease. Nursing mothers.
Fenofibrate Capsules Boxed Warnings
Not Applicable
Fenofibrate Capsules Warnings/Precautions
Warnings/Precautions
Renal impairment. Monitor CBCs for first year; monitor liver function, discontinue if ALT (SGPT) levels >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, or gallstones occur. Pregnancy.
Fenofibrate Capsules Pharmacokinetics
See Literature
Fenofibrate Capsules Interactions
Interactions
Avoid statins. Potentiates oral anticoagulants (monitor). Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with immunosuppressants (eg, cyclosporine), other nephrotoxic drugs.
Fenofibrate Capsules Adverse Reactions
Adverse Reactions
Abnormal liver function tests, elevated CPK, respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased creatinine, rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.
Fenofibrate Capsules Clinical Trials
See Literature
Fenofibrate Capsules Note
Notes
Formerly known under the brand name Lofibra.
Fenofibrate Capsules Patient Counseling
See Literature
