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:

Teva Pharmaceuticals USA, 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 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 t

Product summary:

Omega-3-Acid Ethyl Esters Capsules, USP are available as follows: 1 gram – slightly yellow to yellow liquid, oblong, clear, soft gel capsules, imprinted with “TV 5401” in white ink, in bottles of 120 (NDC 0093-5401-89). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
TEVA PHARMACEUTICALS USA, 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
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OMEGA-3-ACID ETHYL ESTERS CAPSULES.
OMEGA-3-ACID ETHYL ESTERS CAPSULES, FOR ORAL USE
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:
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)
DOSAGE AND ADMINISTRATION
The daily dose of omega-3-acid ethyl esters capsules is 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 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 may increase levels of low-density
lipoprotein (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-acid ethyl esters and
more frequent