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:

EPIC PHARMA, LLC

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

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 42806-552-12) 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.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
EPIC PHARMA, LLC
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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 [EPIC PHARMA LLC 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: 1/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
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)