Lovaza
INDICATIONS
Very High Triglycerides
LOVAZA is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with very high ( > 500 mg/dL) triglyceride levels.
Usage Considerations
In individuals with hypertriglyceridemia (HTG), excess body weight and excess alcohol intake may be important contributing factors 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, if medically indicated, 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 LOVAZA, and should continue this diet during treatment with LOVAZA. In clinical studies, LOVAZA was administered with meals.
The daily dose of LOVAZA 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
LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation REL900.
Bottles of 60: NDC 0173-0783-01
Bottles of 120: NDC 0173-0783-02
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.
Distributed by: GlaxoSmithKline Research Triangle Park, NC 27709. June 2008. FDA rev date: 6/3/2008
Generic Name: Omega-3-Acid Ethyl Esters
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Lovaza
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