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:

Golden State Medical Supply, 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 is 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 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. -  

Product summary:

Omega-3-Acid Ethyl Esters Capsules USP are supplied as 1-gram oblong shaped soft gelatin capsules filled with clear to yellowish liquid and bearing the designation P019. NDC 60429-912-12 Bottles of 120 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. Protect from light. 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, LIQUID
FILLED
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP FOR ORAL USE
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).
Limitations of Use:
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)
DOSAGE AND ADMINISTRATION
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 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. ( 2)
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
In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy. ( 5.1)
Omega-3-acid ethyl esters 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-acid ethyl esters and
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