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:

ANI Pharmaceuticals, 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 th

Ürün özeti:

Omega-3-Acid Ethyl Esters Capsules USP are supplied as 1-gram, soft gelatin oblong capsules filled with a light yellow liquid and imprinted with ANI 410 in white ink. Supplied in bottles of 120 capsules (NDC 62559-410-12). 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 this and all medication out of the reach of children.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
ANI PHARMACEUTICALS, 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 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:
•
•
DOSAGE AND ADMINISTRATION
•
•
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 capsules or any of
its components. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions (incidence >3% and greater than
placebo) were eructation,
dyspepsia, and taste perversion. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ANI PHARMACEUTICALS,
INC. AT 1‑800-308-
6755 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Omega-3-acids may prolong bleeding time. Patients taking omega-3-acid
ethyl esters and an
anticoagulant or other drug affecting coagulation (e.g., anti-platelet
agents) should be monitored
periodically. (7.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2020
The effect of Omega-3-Acid Ethyl Esters Capsules on the risk of
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)
The daily dose of omega-3-acid ethyl esters capsules is 4 grams per
day taken as a single 4-gram
d