Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
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 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 the
Omega-3-acid ethyl esters capsules USP are supplied as 1 gram oblong, clear, soft gel capsules filled with slightly yellow to yellow liquid and imprinted with "PC25" in white ink. They are supplied in bottles of 120 (NDC 24658-350-12) Store at 20° C to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children. Protect from light.
Abbreviated New Drug Application
OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS ---------- 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. 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) Limitations of Use: • • DOSAGE AND ADMINISTRATION • • 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 • • • • ADVERSE REACTIONS The most common adverse reactions (incidence >3% and greater than placebo) were eructation, dyspepsia, and taste perversion. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT [PURACAP LABORATORIES, LLC DBA BLU PHARMACEUTICALS AT 1-888-374-2791] OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid ethyl esters and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically. (7.1) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 8/2023 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) 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 c Belgenin tamamını okuyun