Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
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
TMIG, Inc.
ORAL
PRESCRIPTION DRUG
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
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)
Abbreviated New Drug Application
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 Belgenin tamamını okuyun