OMEGA-3-ACID ETHYL ESTERS- omega-3-acid ethyl esters capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prasco Laboratories

INN (International Name):

OMEGA-3-ACID ETHYL ESTERS

Composition:

OMEGA-3-ACID ETHYL ESTERS 900 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 per 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

Product summary:

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 66993-726-32 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.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
PRASCO LABORATORIES
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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.
OMEGA-3-ACID ETHYL ESTERS CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
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:
•
•
DOSAGE AND ADMINISTRATION
•
•
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
•
•
•
•
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 Omega-3-acid
ethyl esters and an anticoagulant or other drug
affecting coagulation (e.g., anti-platelet agents) should be monitored
periodically. (7.1)
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
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 as two
2-gram doses (2 capsules given t