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:

Atlantic Biologicals Corps

INN (International Adı):

OMEGA-3-ACID ETHYL ESTERS

Kompozisyon:

OMEGA-3-ACID ETHYL ESTERS 900 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

LOVAZA® (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg per dL) hypertriglyceridemia (HTG). Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving LOVAZA and should continue this diet during treatment with LOVAZA. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with LOVAZA. 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 triglyceride-lowering drug therapy. Limitations of Use: The effect of LOVAZA on the risk for

Ürün özeti:

Product: 17856-0084 NDC: 17856-0084-1 50 CAPSULE, LIQUID FILLED in a CUP, UNIT-DOSE

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

LOVAZA- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED
ATLANTIC BIOLOGICALS CORPS
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
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 (HTG). (1)
Limitations of Use:
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 1 gram (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
•
•
•
•
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 GLAXOSMITHKLINE AT
1-888-825-5249 OR FDA AT 1-800-
FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Omega-3-acids may prolong bleeding time. Patients taking LOVAZA and an
anticoagulant or other drug affecting
coagulation (e.g., anti-platelet agents) should be monitored
periodically. (7.1)
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
®
The effect of LOVAZA on the risk for pancreatitis has not been
determined. (1)
The effect of LOVAZA on cardiovascular mortality and morbidity has not
been determined. (1)
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)
In patients with hepatic impairment, m