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Antara Generic Name & Formulations
Legal Class
Rx
General Description
Fenofibrate 30mg, 90mg; caps.
Pharmacological Class
Fibrate.
How Supplied
Caps 30mg—30; 90mg—30, 90, 100
Manufacturer
Generic Availability
NO
Antara Indications
Indications
Adjunct to diet when response to nondrug therapy is inadequate in hypertriglyceridemia, and to reduce elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C, in primary hypercholesterolemia and mixed dyslipidemia.
Limitations of Use
Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.
Antara Dosage and Administration
Adult
Swallow whole. Take without regard to food. Hypertriglyceridemia: 30–90mg/day, adjust at 4–8 week intervals; max 90mg/day. Hypercholesterolemia, dyslipidemia: 90mg/day. Renal impairment (mild to moderate): initially 30mg/day; (severe): avoid. Elderly: select dose based on renal function. Discontinue if inadequate response after 2 months on max dose.
Children
Not established.
Antara Contraindications
Contraindications
Severe renal impairment including on dialysis. Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.
Antara Boxed Warnings
Not Applicable
Antara 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 (acute and delayed), or paradoxical decreases in HDL-C occur (do not reinitiate). Diabetes. Hypothyroidism. Renal impairment: monitor. Elderly. Pregnancy (Cat.C).
Antara Pharmacokinetics
See Literature
Antara Interactions
Interactions
Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR); caution. Allow at least 1hr before or 4–6hrs after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.
Antara Adverse Reactions
Adverse Reactions
Abnormal LFTs, increased AST/ALT, increased CPK, rhinitis, respiratory or GI effects; hepatotoxicity, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, hypersensitivity reactions (may be severe), rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.
Antara Clinical Trials
See Literature
Antara Note
Not Applicable
Antara Patient Counseling
See Literature
