מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)
International Brand Management Inc
OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS 1 g in 1 g
ORAL
PRESCRIPTION DRUG
Each capsule contains 1 gram of Omega-3 acid ethyl esters liquid concentrate consisting of at least 900 mg of Omega-3 acid ethyl esters.
Abbreviated New Drug Application
OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE INTERNATIONAL BRAND MANAGEMENT INC ---------- Each capsule contains 1 gram of Omega-3 acid ethyl esters liquid concentrate consisting of at least 900 mg of Omega-3 acid ethyl esters. OMEGA-3-ACID ETHYL ESTERS - omega-3-acid ethyl esters capsule, liquid filled International Brand Management, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use omega-3-acid ethyl esters capsules, USP safely and effectively. See full prescribing information for omega-3-acid ethyl esters capsules, USP. OMEGA-3-ACID ETHYL ESTERS Capsules, USP for oral use Initial U.S. Approval: 2004 RECENT MAJOR CHANGES Indications and Usage, Limitations of Use (1) 06/2013 INDICATIONS AND USAGE Omega-3-acid ethyl esters, USP is a combination of ethyl esters of omega 3 fatty acids, principally EPA and DHA, indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG). (1) (1) Limitations of Use: (1) The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. (1) The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined. (1) DOSAGE AND ADMINISTRATION The daily dose of omega-3-acid ethyl esters 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) (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 capsules or any of its components. (4) (4) WARNINGS AND PRECAUTIONS In patients with hepatic impairment, monitor ALT and AST levels periodically during the קרא את המסמך השלם