Application Nr Approved Date Route Status External Links
NDA019018 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Trophamine ® Is Indicated For The Nutritional Support Of Infants (including Those Of Low Birth Weight) And Young Pediatric Patients Requiring Tpn Via Either Central Or Peripheral Infusion Routes. Parenteral Nutrition With Trophamine ® Is Indicated To Prevent Nitrogen And Weight Loss Or Treat Negative Nitrogen Balance In Infants And Young Pediatric Patients Where (1) The Alimentary Tract, By The Oral, Gastrostomy, Or Jejunostomy Route, Cannot Or Should Not Be Used, Or Adequate Protein Intake Is Not Feasible By These Routes; (2) Gastrointestinal Absorption Of Protein Is Impaired; Or (3) Protein Requirements Are Substantially Increased As With Extensive Burns. Dosage, Route Of Administration, And Concomitant Infusion Of Non-Protein Calories Are Dependent On Various Factors, Such As Nutritional And Metabolic Status Of The Patient, Anticipated Duration Of Parenteral Nutritional Support, And Vein Tolerance. See Warnings , Precautions, Pediatric Use , And Dosage And Administration . Central Venous Nutrition Central Venous Infusion Should Be Considered When Amino Acid Solutions Are To Be Admixed With Hypertonic Dextrose To Promote Protein Synthesis In Hypercatabolic Or Severely Depleted Infants, Or Those Requiring Long-Term Parenteral Nutrition. Peripheral Parenteral Nutrition For Moderately Catabolic Or Depleted Patients In Whom The Central Venous Route Is Not Indicated, Diluted Amino Acid Solutions Mixed With 5–10% Dextrose Solutions May Be Infused By Peripheral Vein, Supplemented, If Desired, With Fat Emulsion. In Pediatric Patients, The Final Solution Should Not Exceed Twice Normal Serum Osmolarity (718 Mosmol/l).

All Formulated Excipients (0 Total)

None

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