Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
Omega-3-Acid Ethyl Esters (UNII: D87YGH4Z0Q) (Omega-3 Fatty Acids - UNII:71M78END5S)
XLCare Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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 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. 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. Limitation
Omega-3-acid ethyl esters capsules, USP are supplied as 1 gram clear, transparent oblong capsules containing clear to light yellow colored solution imprinted with ‘AT 132’ with white ink. Bottles of 120: NDC 72865-139-12 Bottles of 500: NDC 72865-139-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. Keep out of reach of children.
Abbreviated New Drug Application
OMEGA-3-ACID ETHYL ESTERS - OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED XLCARE PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEGA-3-ACID ETHYL ESTERS CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEGA-3-ACID ETHYL ESTERS CAPSULES. OMEGA-3-ACID ETHYL ESTERS CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE 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) (1) Limitations of Use: (1) The effect of omega-3-acid ethyl esters on the risk for pancreatitis has not been determined. (1) The effect of omega-3-acid ethyl esters on cardiovascular mortality and morbidity has not been determined. (1) DOSAGE AND ADMINISTRATION The daily dose of omega-3-acid ethyl esters capsules is 4 grams per day taken as a single 4-gram dose (4 capsules) or as two 2-gram doses (2 capsules given twice daily). (2) Patients should be advised to swallow omega-3-acid ethyl esters capsules whole. Do not break open, crush, dissolve, or chew omega-3-acid ethyl esters capsules. (2) DOSAGE FORMS AND STRENGTHS Capsules: 1 gram (3) CONTRAINDICATIONS Omega-3-acid ethyl esters capsules are contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any of its components. (4) WARNINGS AND PRECAUTIONS In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy. (5.1) Omega-3-acid ethyl esters capsules may increase levels of low-density lipoprotein (LDL). Monitor LDL levels periodically during therapy. (5.1) Use with caution in patients with known hypersensitivity to fish and/or shellfish. (5.2) There is a possible association between omega-3-acid ethyl esters and more frequent re Прочитать полный документ