LOVAZA- omega-3-acid ethyl esters capsule, liquid filled

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

OMEGA-3-ACID ETHYL ESTERS (UNII: D87YGH4Z0Q) (OMEGA-3-ACID ETHYL ESTERS - UNII:D87YGH4Z0Q)

Доступна с:

Rebel Distributors Corp

ИНН (Международная Имя):

OMEGA-3-ACID ETHYL ESTERS

состав:

OMEGA-3-ACID ETHYL ESTERS 1 g

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

LOVAZA® (omega-3-acid ethyl esters) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. 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 LOVAZA therapy. 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 cardiovascular mortality and morbidity in patients

Обзор продуктов:

LOVAZA (omega-3-acid ethyl esters) capsules are supplied as 1-gram transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation LOVAZA. Bottles of 120: NDC 21695-795-72 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 out of reach of children.

Статус Авторизация:

New Drug Application

Характеристики продукта

LOVAZA- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID FILLED
REBEL DISTRIBUTORS CORP
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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
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. (1)
(1)
Limitations of Use: The effect of LOVAZA on cardiovascular mortality
and morbidity in patients with elevated triglycerides
has not been determined. (1) (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) (3)
CONTRAINDICATIONS
LOVAZA is contraindicated in patients with known hypersensitivity
(e.g., anaphylactic reaction) to LOVAZA or any of its
components. (4) (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)
ADVERSE REACTIONS
The most common adverse events (incidence >3% and greater than
placebo) were eructation, infection, flu syndrome,
and dyspepsia. (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 should be monitored periodically. (7.1) (7)
USE I