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:

Atlantic Biologicals Corps

INN (International Adı):

OMEGA-3-ACID ETHYL ESTERS

Kompozisyon:

OMEGA-3-ACID ETHYL ESTERS 1 g

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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). 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. Usage Considerations: Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules, USP. 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 consider

Ürün özeti:

NDC:17856-0034-2 in a POUCH of 50 CAPSULE, LIQUID FILLEDS

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
ATLANTIC BIOLOGICALS CORPS
----------
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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use 06/2013 (1)
INDICATIONS AND USAGE
Omega-3-acid ethyl esters capsules, USP are 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:
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 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, USP whole. Do not break open, crush,
dissolve, or chew omega-3-acid ethyl esters capsules, USP. (2)
DOSAGE FORMS AND STRENGTHS
1 gram transparent soft-gelatin capsules. (3)
CONTRAINDICATIONS
Omega-3-acid ethyl esters capsules, USP are contraindicated in
patients with known hypersensitivity (e.g., anaphylactic
reaction) to omega-3-acid ethyl esters, USP 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 associati