OMEGA-3-ACID ETHYL ESTERS capsule

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:

Par Pharmaceutical Inc.

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 capsules, USP are 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 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 consideration of triglyceride-lowering drug ther

Product summary:

Omega-3-Acid Ethyl Esters Capsules, USP are supplied as 1-gram clear, natural colored oblong shaped soft gelatin capsules containing pale yellow colored oily liquid imprinted with '740' Bottles of 120: NDC 0254-3010-08 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) Protect from light. [See USP Controlled Room Temperature]. Do not freeze. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE
PAR PHARMACEUTICAL INC.
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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, 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
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1) 05/2014
INDICATIONS AND USAGE
Omega-3-acid ethyl esters capsules, USP are 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:
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)
DOSAGE AND ADMINISTRATION
The daily dose of omega-3-acid ethyl esters capsules, USP are 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 capsules. (2)
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
In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy. (5.1)
Omega-3-acid ethyl esters capsules 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