Omega3 Acid Ethyl Esters USP 1000 MG Oral Capsule
1 INDICATIONS AND USAGE Omega-3-acid ethyl esters capsules are 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 omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. 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 omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. Omega-3-acid ethyl esters capsules are 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 (≥500 mg/dL) hypertriglyceridemia. (1) Limitations of Use: The effect of omega-3-acid ethyl esters capsules on the risk for pancreatitis has not been determined. (1) The effect of omega-3-acid ethyl esters capsules on cardiovascular mortality and morbidity has not been determined. (1)
Amneal Pharmaceuticals LLC
CAPSULE YELLOW AN34
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16 HOW SUPPLIED/STORAGE AND HANDLING
OMEGA-3-ACID ETHYL ESTERS capsules USP, are supplied as 1 gram, transparent, soft-gelatin capsules filled with light-yellow oil and imprinted with “AN34”. They are available as follows: Bottles of 60: NDC 65162-034-06 Bottles of 120: NDC 65162-034-16 Bottles of 360: NDC 65162-034-32 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Dispense in a tight, light-resistant container. Protect from light. Keep out of reach of children.
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