LOVAZA 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:

Cardinal Health

INN (International Adı):

OMEGA-3-ACID ETHYL ESTERS

Kompozisyon:

OMEGA-3-ACID ETHYL ESTERS 1 g

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

LOVAZA- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED
CARDINAL HEALTH
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LOVAZA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR LOVAZA.
LOVAZA (OMEGA-3-ACID ETHYL ESTERS) CAPSULES
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Warnings and Precautions, Recurrent Atrial Fibrillation or Flutter
(5.3)
08/2012
INDICATIONS AND USAGE
LOVAZA is 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. (1)
Limitations of Use: The effect of LOVAZA on cardiovascular mortality
and morbidity in patients with elevated triglycerides
has not been determined. (1)
DOSAGE AND ADMINISTRATION
•The daily dose of LOVAZA 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 LOVAZA capsules whole. Do not
break open, crush, dissolve or chew LOVAZA.
(2)
DOSAGE FORMS AND STRENGTHS
1-gram transparent soft-gelatin capsules. (3)
CONTRAINDICATIONS
LOVAZA is contraindicated in patients with known hypersensitivity
(e.g., anaphylactic reaction) to LOVAZA or any of its
components. (4)
WARNINGS AND PRECAUTIONS
•In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy. (5.1)
•LOVAZA 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 LOVAZA and more frequent
recurrences of symptomatic atrial fibrillation or
flutter in patients with paroxysmal or persistent atrial fibrillation,
particularly within the first months of initiating therapy.
(5.3)
ADVERSE REACTIONS
The most common adverse reactions (incidence >3% and greater than
placebo) were eructation, dyspepsia, a