OMEGA-3-ACID ETHYL ESTERS- omega-3-acid ethyl esters capsules capsule, liquid filled

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Lifestar Pharma LLC

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Omega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: 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. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. 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 TG-lowering drug t

Περίληψη προϊόντος:

Omega-3-acid ethyl esters capsules, USP are supplied as 1-gram, transparent, soft-gelatin capsules filled with light to pale yellow oil and bearing the designation "LS 423" on one side of the capsules. Bottles of 120: NDC 70756-423-22. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light and do not freeze. Keep out of reach of children. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

OMEGA-3-ACID ETHYL ESTERS - OMEGA-3-ACID ETHYL ESTERS CAPSULES
CAPSULE, LIQUID FILLED
LIFESTAR PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEGA-3-ACID ETHYL ESTERS CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEGA-3-ACID ETHYL
ESTERS CAPSULES.
OMEGA-3-ACID ETHYL ESTERS CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Omega-3-acid ethyl esters capsules are combination of ethyl esters of
omega 3 fatty acids, principally eicosapentaenoic acid (EPA)
and docosahexaenoic acid (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 omega-3-acid ethyl esters capsules on the risk for
pancreatitis has not been determined. (1)
The effect of omega-3-acid ethyl esters capsules on cardiovascular
mortality and morbidity has not been determined. (1)
DOSAGE AND ADMINISTRATION
The daily dose of omega-3-acid ethyl esters capsules 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)
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)
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 low-density
lipoprotein (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 omega-3-acid ethyl esters
caps