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:

Major Pharmaceuticals

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Omega-3-acid ethyl esters capsules, USP 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, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP.             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 consi

Обзор продуктов:

Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram transparent, oblong soft gelatin capsules with light yellowish oil printed with white ink (Logo “APO900”). They are supplied as follows: Cartons of 50 capsules (10 capsules per blister card x 5), NDC 0904-6706-06 Store in tight, light-resistant containers at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze. Keep out of reach of children.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
MAJOR PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEGA-3-ACID ETHYL
ESTERS CAPSULES, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR OMEGA-
3-ACID ETHYL ESTERS CAPSULES, USP.
OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Omega-3-acid ethyl esters, USP 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:
3.
4.
DOSAGE AND ADMINISTRATION
3.
4.
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 capsules or any of
its components. (4)
WARNINGS AND PRECAUTIONS
5.
6.
7.
8.
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 APOTEX CORP. AT
1-800-706-5575 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 capsules 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: 12/2022
The effect of omega-3-acid ethyl esters capsules, USP on the risk for
pancreatitis has not been
determined. (1)
The effect of omega-3-acid ethyl esters capsules, USP on
cardiovascular mortality and morbidity has
not been determined. (1)
The daily dose of omega-3-acid ethyl esters is 4 grams per day taken
as a single 4-gram dose (4