OMEGA-3-ACID ETHYL ESTERS capsule

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:

KD Pharma USA, Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Omega-3-acid ethyl esters, USP are supplied as 1-gram oblong, transparent soft gelatin capsules filled with light yellowish oil printed with "O3" in white ink across one side. Bottles of 120: NDC 72998-850-12 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.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE
KD PHARMA 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 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 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 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 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 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 recurrences of
symptomatic atrial fibrillation or flutter in patients with paroxysmal
or persistent atrial fibrillation,
particularly within the first month