Country: United States
Language: English
Source: NLM (National Library of Medicine)
OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)
Par Pharmaceutical, Inc.
OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS 900 mg
ORAL
PRESCRIPTION DRUG
- 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). - 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. - 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 triglyceride-lowering drug therapy. - Limitations of Use: - The
Omega-3-Acid Ethyl Esters Capsules USP are supplied as 1-gram oblong shaped soft gelatin capsules filled with clear to yellowish liquid and bearing the designation P019. NDC 49884-019-02 Bottles of 60 NDC 49884-019-08 Bottles of 120 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. 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 PAR PHARMACEUTICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEGA-3-ACID ETHYL ESTERS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEGA-3-ACID ETHYL ESTERS CAPSULES. 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 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). Limitations of Use: 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 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. (2) DOSAGE FORMS AND STRENGTHS Capsules: 1-gram (3) CONTRAINDICATIONS Omega-3-acid ethyl esters is 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 may increase levels of 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 recurrences of symptomatic atrial fibrillation or flutter in Read the complete document