OMEGA-3-ACID ETHYL ESTERS capsule, liquid filled

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Direct_Rx

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Omega-3-acid ethyl esters capsules, USP are 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 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 trigl

Ringkasan produk:

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 30s Bottles of 60s Bottles of 120s 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.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

OMEGA-3-ACID ETHYL ESTERS- OMEGA-3-ACID ETHYL ESTERS CAPSULE, LIQUID
FILLED
DIRECT_RX
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OMEGA-3-ACID ETHYL ESTERS
Omega-3-acid ethyl esters capsules, USP are 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
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.
Assess triglyceride levels carefully before initiating therapy.
Identify other causes (e.g., diabetes
mellitus, hypothyroidism, medications) of high triglyceride levels and
manage as appropriate [see
Indications and Usage (1)].
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.
In clinical studies, omega-3-acid ethyl esters capsules were
administered with meals.
The daily dose of omega-3-acid ethyl esters capsules is 4 grams per
day. The daily dose may be taken