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Omacor (Omega-3-Acid Ethyl Esters) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Omacor is indicated as an adjunct to diet to reduce very high (≥ 500 mg/dL) triglyceride (TG) levels in adult patients.

Usage Considerations

According to accepted clinical guidelines, excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia (HTG) and should be addressed before initiating any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, (such as hypothyroidism or diabetes mellitus) should be looked for and adequately treated. Estrogen therapy, thiazide diuretics, and beta blockers are sometimes associated with massive rises in plasma TG levels. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy for HTG.

The use of lipid-regulating agents should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use lipid-regulating agents, the patient should be advised that use of lipid-regulating agents does not reduce the importance of adhering to diet. (See PRECAUTIONS).

Dosage and Administration

Patients should be placed on an appropriate lipid-lowering diet before receiving Omacor, and should continue this diet during treatment with Omacor. In clinical studies, Omacor was administered with meals.

The daily dose of Omacor is 4 g per day. The daily dose may be taken as a single 4-g dose (4 capsules) or as two 2-g doses (2 capsules given twice daily).

How Supplied

Omacor (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation OMACOR in bottles of 60 (NDC 65726-424-15) and 120 (NDC 65726-424-27).

Recommended Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Do not freeze.

Keep out of reach of children.

Rx only

April 2005

Distributed by:

Reliant Pharmaceuticals, Inc.

Liberty Corner, NJ 07938

Address Medical Inquiries to:

Reliant Pharmaceuticals, Inc.

Medical Affairs

110 Allen Road

Liberty Corner, NJ 07938

©2005 Reliant Pharmaceuticals, Inc.

4241F-00

PRINTED IN USA

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