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:

American Health Packaging

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 (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, USP and should continue this diet during treatment with omega-3-acid ethyl esters capsules, USP. 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 TG-lowering dr

Ürün özeti:

Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram transparent, oblong soft gelatin capsules with light yellowish oil printed with white ink (Logo “APO900”). They are supplied as follows: Unit dose packages of 50 (5 x 10) NDC 60687-127-65 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze. Keep out of reach of children. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEGA-3-ACID ETHYL
ESTERS CAPSULES, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR OMEGA-
3-ACID ETHYL ESTERS CAPSULES, USP
OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Omega-3-acid ethyl esters, USP 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 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 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 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
In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy. (5.1)
Omega-3-acid ethyl esters capsules 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 es