Monograph Details
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Cardiovascular System
> Hyperlipoproteinemias
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ANTARA |
| Manufacturer |
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Oscient Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Fibrate. |
| Generic Name |
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Fenofibrate 43mg, 130mg; caps. |
| Indications |
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Adjunct to diet when response to nondrug therapy is inadequate in hypertriglyceridemia (Types IV and V), and to reduce elevated total-C, LDL-C, apo B, and TG, and to increase HDL-C, in primary hypercholesterolemia and mixed dyslipidemia (Type IIa and IIb). |
| Children |
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Not recommended. |
| Adults |
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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. |
| Contraindications |
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Hepatic dysfunction. Primary biliary cirrhosis. Severe renal dysfunction. Gallbladder disease. |
| Precautions |
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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 (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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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 immunosuppressants (eg, cyclosporine), other nephrotoxic drugs. |
| Adverse Reactions |
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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 |
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Caps—30 |
| Additional Resources |
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• Related Prescribing Note |
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