OMEGA-3-ACID ETHYL ESTERS capsule, liquid filled

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)

제공처:

Bryant Ranch Prepack

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 the

제품 요약:

NDC: 71335-2024-1: 90 CAPSULEs in a BOTTLE NDC: 71335-2024-2: 28 CAPSULEs in a BOTTLE NDC: 71335-2024-3: 60 CAPSULEs in a BOTTLE NDC: 71335-2024-4: 120 CAPSULEs in a BOTTLE NDC: 71335-2024-5: 100 CAPSULEs in a BOTTLE NDC: 71335-2024-6: 30 CAPSULEs in a BOTTLE

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
BRYANT RANCH PREPACK
----------
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.
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:
The effect of omega-3-acid ethyl esters capsules on the risk for
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)
DOSAGE AND ADMINISTRATION
The daily dose of omega-3-acid ethyl esters capsules 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 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 o