OMEGA-3-ACID ETHYL ESTER- 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:

Bionpharma Inc.

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Omega-3-acid ethyl esters capsules, USP are supplied as 1 gram, transparent, soft-gelatin capsules filled with light-yellow oil and bearing the imprint “5038”. Bottles of 60:              NDC 69452-175-17 Bottles of 120:            NDC 69452-175-22 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light. Do not freeze. Keep out of reach of children.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

OMEGA-3-ACID ETHYL ESTER- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
BIONPHARMA INC.
----------
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 is 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 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 capsules. ( 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 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 recurrences of
symptomatic atrial fibrillation or flut