OMEGA-3-ACID ETHYL ESTERS capsule liquid filled

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Avera McKennan Hospital

INN (International Adı):

OMEGA-3-ACID ETHYL ESTERS

Kompozisyon:

OMEGA-3-ACID ETHYL ESTERS 900 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
AVERA MCKENNAN HOSPITAL
----------
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).
(1)
Limitations of Use: (1)
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 1-gram (3) (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) (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PAR PHARMACEUTICAL AT
1-800-828-9393 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
The most common adverse reactions (incidence >3% and greater than
placebo) were eructation, dyspepsia and taste
perversion. (6)
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) (7)
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2016
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)
The daily dose of omega-3-acid ethyl esters is 4 grams per day taken
as a single 4-gram dose (4 capsules) or