国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)
GlaxoSmithKline LLC
OMEGA-3-ACID ETHYL ESTERS
OMEGA-3-ACID ETHYL ESTERS 900 mg
ORAL
PRESCRIPTION DRUG
LOVAZA (omega-3-acid ethyl esters) is 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 LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. 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 LOVAZA on the risk for pancreatitis has not
LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram, transparent, soft-gelatin capsules filled with light-yellow oil and bearing the designation “GS FH2”. Bottles of 120: NDC 0173-0884-08. 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. Keep out of reach of children.
New Drug Application
LOVAZA- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED GLAXOSMITHKLINE LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LOVAZA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOVAZA. LOVAZA (OMEGA-3-ACID ETHYL ESTERS CAPSULES), FOR ORAL USE INITIAL U.S. APPROVAL: 2004 INDICATIONS AND USAGE LOVAZA is 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 LOVAZA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA 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 GLAXOSMITHKLINE AT 1-888-825-5249 OR FDA AT 1-800- FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS Omega-3-acids may prolong bleeding time. Patients taking LOVAZA 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 AND FDA-APPROVED PATIENT LABELING. REVISED: 9/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION The effect of LOVAZA on the risk for pancreatitis has not been determined. (1) The effect of LOVAZA on cardiovascular mortality and morbidity has not been determined. (1) The daily dose of LOVAZA 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 LOVAZA capsules whole. Do not break open, crush, dissolve, or chew 阅读完整的文件