What is the generic name?

OMEGA-3-ACID ETHYL ESTERS

What is the Trade Name for OMEGA-3-ACID ETHYL ESTERS?

LOVAZA

What are the Indications for OMEGA-3-ACID ETHYL ESTERS?

• 1 INDICATIONS AND USAGE LOVAZA (omega-3-acid ethyl esters capsules) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: 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 TG-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. LOVAZA is a combination of ethyl esters of omega 3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (‚â•500 mg/dL) hypertriglyceridemia. (1) Limitations of Use: The effect of LOVAZA on the risk for pancreatitis has not been determined. (1) The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. (1)

References: https://open.fda.gov/