Hyperlipoproteinemias:

Indications for: ANTARA

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.

Adult Dosage:

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 Dosage:

Not established.

ANTARA Contraindications:

Severe renal impairment including on dialysis. Active liver disease. Primary biliary cirrhosis. Unexplained persistent liver function abnormalities. Gallbladder disease. Nursing mothers.

ANTARA 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 Classification:

Fibrate.

ANTARA 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.

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.

Generic Drug Availability:

NO

How Supplied:

Caps 30mg—30; 90mg—30, 90, 100

Pricing for ANTARA

130mg capsule (Qty: 30)
Appx. price $47
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