OMEGA-3-ACID ETHYL ESTERS capsule, liquid filled

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)

Доступна с:

A-S Medication Solutions

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

-  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

Обзор продуктов:

Product: 50090-3957 NDC: 50090-3957-0 120 CAPSULE, LIQUID FILLED in a BOTTLE, PLASTIC

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
A-S MEDICATION SOLUTIONS
----------
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 pa