OMEGA-3 RX COMPLETE kit

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9), PHYTONADIONE (UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857), THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACINAMIDE (UNII: 25X51I8RD4) (NI

Disponible depuis:

TMIG, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 consider

Descriptif du produit:

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 (NDC 60505-3170-3) Bottles of 60s (NDC 60505-3170-6) Bottles of 120s (NDC 60505-3170-7) 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. Omega-3 Support vitamin and mineral suppliment are supplied capsules They are supplied in bottles of 60 ( 69176-190-10) 

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

OMEGA-3 RX COMPLETE- OMEGA-3 RX COMPLETE
TMIG, INC.
----------
OMEGA-3 RX COMPLETE
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. NDC 60505-3170-7.
Also see full prescribing information of all package inserts inside
product kit.
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:
Sections or subsections omitted from the full prescribing information
are not listed.
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.
As Always only take the prescribed dosages as per your physicans
directions.
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