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ANTARA
Hyperlipoproteinemias
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Drug Name:

ANTARA Rx

Generic Name and Formulations:
Fenofibrate 43mg, 130mg; caps.

Company:
Lupin Pharmaceuticals, Inc.

Therapeutic Use:

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: was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.

Adult:

Take with food. Hypertriglyceridemia: 43–130mg/day, adjust at 4–8 week intervals; max 130mg/day. Hypercholesterolemia, dyslipidemia: 130mg/day. Renal impairment or elderly: initially 43mg/day. Discontinue if inadequate response after 2 months on max dose.

Children:

Not established.

Contraindications:

Hepatic dysfunction. Primary biliary cirrhosis. Severe renal dysfunction. Gallbladder disease. Nursing mothers.

Warnings/Precautions:

Renal impairment (monitor). Monitor CBCs for first year; monitor liver function; discontinue if ALT (SGPT) levels >3xULN persist. Discontinue if markedly elevated CPK levels, myopathy, gallstones, or paradoxical decreases in HDL-C occur. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR). Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine), other nephrotoxic drugs.

Pharmacological Class:

Fibrate.

Adverse Reactions:

Abnormal liver function tests, elevated CPK, respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased BUN or creatinine, rash; rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.

How Supplied:

Caps—30

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