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:

AvKARE

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 (≥500 mg/dL) hypertriglyceridemia (HTG).             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 triglyceride-lowering drug therapy.             Limitations of Use: The effect of omega-3-acid ethyl esters capsules, USP on the risk for pancreatitis has not been determined. The effect of omega-3-acid ethyl esters capsules, USP on cardiovascular mortality and morbidity has not been determined. 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. Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. It is unknown whether omega-3-acid ethyl esters capsules can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Omega-3-acid ethyl esters capsules should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Animal Data: Omega-3-acid ethyl esters have been shown to have an embryocidal effect in pregnant rats when given in doses resulting in exposures 7 times the recommended human dose of 4 grams/day based on a body surface area comparison.             In female rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day beginning 2 weeks prior to mating and continuing through gestation and lactation, no adverse effects were observed in the high-dose group (5 times human systemic exposure following an oral dose of 4 grams/day based on body surface area comparison).            In pregnant rats given oral gavage doses of 1,000, 3,000, and 6,000 mg/kg/day from gestation day 6 through 15, no adverse effects were observed (14 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).             In pregnant rats given oral gavage doses of 100, 600, and 2,000 mg/kg/day from gestation day 14 through lactation day 21, no adverse effects were seen at 2,000 mg/kg/day (5 times the human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison). However, decreased live births (20% reduction) and decreased survival to postnatal day 4 (40% reduction) were observed in a dose-ranging study using higher doses of 3,000 mg/kg/day (7 times the human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison).             In pregnant rabbits given oral gavage doses of 375, 750, and 1,500 mg/kg/day from gestation day 7 through 19, no findings were observed in the fetuses in groups given 375 mg/kg/day (2 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison). However, at higher doses, evidence of maternal toxicity was observed (4 times human systemic exposure following an oral dose of 4 grams/day based on a body surface area comparison). Studies with omega-3-acid ethyl esters have demonstrated excretion in human milk. The effect of this excretion on the infant of a nursing mother is unknown; caution should be exercised when omega-3-acid ethyl esters capsules are administered to a nursing mother. An animal study in lactating rats given oral gavage 14 C-ethyl EPA demonstrated that drug levels were 6 to 14 times higher in milk than in plasma. Safety and effectiveness in pediatric patients have not been established. A limited number of subjects older than 65 years were enrolled in the clinical trials of omega-3-acid ethyl esters capsules. Safety and efficacy findings in subjects older than 60 years did not appear to differ from those of subjects younger than 60 years. Omega-3-acid ethyl esters capsules do not have any known drug abuse or withdrawal effects.

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: Bottles of 120s  (NDC 42291-657-12)        Store in tight, light-resistant containers 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.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
OMEGA-3-ACID ETHYL ESTERS CAPSULES, USP
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
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1) 06/2013
INDICATIONS AND USAGE
Omega-3-acid ethyl esters, USP 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) (1)
Limitations of Use: (1)
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) (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) (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 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 poss