Fenoglide Generic Name & Formulations
Legal Class
Rx
General Description
Fenofibrate 40mg, 120mg; tabs.
Pharmacological Class
Fibrate.
How Supplied
Tabs—90
Manufacturer
Generic Availability
YES
Fenoglide Indications
Indications
Adjunct to diet in severe hypertriglyceridemia and to reduce elevated LDL-C, total-C, TG, and apo B, and to increase HDL-C, in primary hyperlipidemia or mixed dyslipidemia.
Limitations of Use
Not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.
Fenoglide Dosage and Administration
Adult
Take with food. Hypertriglyceridemia: 40–120mg/day; adjust at 4–8 week intervals; max 120mg/day. Hyperlipidemia, dyslipidemia: initially 120mg/day. Mild to moderately renal impairment: initially 40mg/day. Elderly: select dose based on renal function.
Children
Not established.
Fenoglide Contraindications
Contraindications
Severe renal impairment (including dialysis). Active liver disease. Unexplained persistent liver function abnormalities. Primary biliary cirrhosis. Gallbladder disease. Nursing mothers (during and for 5 days after last dose).
Fenoglide Boxed Warnings
Not Applicable
Fenoglide Warnings/Precautions
Warnings/Precautions
Risk of serious liver injury. Monitor liver function at baseline and periodically during therapy; discontinue if liver injury develops or if elevated enzymes persist (ALT or AST >3×ULN, or if accompanied by elevated bilirubin); do not restart if no alternative explanation. Monitor CBCs during the first year. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions, or paradoxical decreases in HDL occur (do not reinitiate). Diabetes. Hypothyroidism. Mild to moderate renal impairment: reduce dose; monitor. Elderly. Pregnancy.
Fenoglide Pharmacokinetics
See Literature
Fenoglide Interactions
Interactions
Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR); caution. Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.
Fenoglide Adverse Reactions
Adverse Reactions
Abnormal liver function tests, increased AST, ALT, CPK, rhinitis; respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, rash, hypersensitivity reactions (may be severe); rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.
Fenoglide Clinical Trials
See Literature
Fenoglide Note
Not Applicable
Fenoglide Patient Counseling
See Literature