DRUG INTERACTIONS Drug Interactions
Oral Anticoagulants: CAUTION SHOULD BE EXERCISED WHEN COUMARIN ANTICOAGULANTS ARE GIVEN IN CONJUNCTION WITH ANTARA. THE DOSAGE OF THE ANTICOAGULANTS SHOULD BE REDUCED TO MAINTAIN THE PROTHROMBIN TIME/INR AT THE DESIRED LEVEL TO PREVENT BLEEDING COMPLICATIONS. FREQUENT PROTHROMBIN TIME/INR DETERMINATIONS ARE ADVISABLE UNTIL IT HAS BEEN DEFINITELY DETERMINED THAT THE PROTHROMBIN TIME/INR HAS STABILIZED.
HMG-CoA Reductase Inhibitors: The combined use of Antara and HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of this drug combination (see WARNINGS).
Resins: Since bile acid sequestrants may bind other drugs given concurrently, patients should take Antara at least 1 hour before or 4-6 hours after a bile acid binding resin to avoid impeding its absorption.
Cyclosporine: Because cyclosporine can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including Antara, there is a risk that an interaction will lead to deterioration. The benefits and risks of using Antara with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dose employed.
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OVERDOSAGE
There is no specific treatment for overdose with Antara. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibrate is highly bound to plasma proteins, hemodialysis should not be considered.
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CONTRAINDICATIONS
Antara is contraindicated in patients who exhibit hypersensitivity to fenofibrate.
Fenofibrate is contraindicated in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis, and patients with unexplained persistent liver function abnormality.
Fenofibrate is contraindicated in patients with preexisting gallbladder disease (see WARNINGS).
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REFERENCES
1. GOLDBERG AC, et al. Fenofibrate for the Treatment of Type IV and V Hyperlipoproteinemias: A Double-Blind, Placebo-Controlled Multicenter US Study. Clinical Therapeutics, 11, ppg. 69-83, 1989.
2. NIKKILA EA. Familial Lipoprotein Lipase Deficiency and Related Disorders of Chylomicron Metabolism. In Stanbury J.B., et al. (eds.): The Metabolic Basis of Inherited Disease, 5th edition, McGraw-Hill, 1983, Chap. 30, pp. 622-642.
3. BROWN WV, et al. Effects of Fenofibrate on Plasma Lipids: Double-Blind, Multicenter Study In Patients with Type II A or II B Hyperlipidemia. Arteriosclerosis. 6, pp. 670-678, 1986.
Rx only
REV: July 2007
Distributed by:
Oscient Pharmaceuticals Corporation
Waltham, MA 02451
OSCIENT PHARMACEUTICALS
Address Medical Inquiries to:
Oscient Medical Inquiries
c/o Med Comm Solutions
1900 Powell Street, Suite 880
Emeryville, CA 94608
or Call: 866-432-2848
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