LOVAZA® (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe ( > 500 mg/dL) hypertriglyceridemia (HTG).
Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA.
Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. Every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that are contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens) should be discontinued or changed if possible prior to consideration of triglyceride-lowering drug therapy.
Limitations of Use
DOSAGE AND ADMINISTRATION
- Assess triglyceride levels carefully before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, medications) of high triglyceride levels and manage as appropriate [see INDICATIONS AND USAGE].
- 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 grams per day. The daily dose may be taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily).
Patients should be advised to swallow LOVAZA capsules whole. Do not break open, crush, dissolve, or chew LOVAZA.
Dosage Forms And Strengths
LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent, softgelatin capsules filled with light-yellow oil and bearing the designation LOVAZA.
Storage And Handling
LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram, transparent, softgelatin capsules filled with light-yellow oil and bearing the designation LOVAZA.
Bottles of 120: NDC 0173-0783-02.
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.
Manufactured for: GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: May 2014
Last reviewed on RxList: 6/2/2014
This monograph has been modified to include the generic and brand name in many instances.
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