TrophAmine .24 g/100mL
ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE · SOLUTION · B. Braun Medical Inc.
TrophAmine is a solution containing isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochloride, histidine, tyrosine, n-acetyl-tyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, glutamic acid, and taurine at .24 g/100mL, taken intravenous. Manufactured by B. Braun Medical Inc..
Key Facts
- Brand Name
- TrophAmine
- Generic Name
- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE
- NDC Code (Product)
0264-1933- Manufacturer
- B. Braun Medical Inc.
- Strength
- .24 g/100mL
- Dosage Form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA019018
- Drug Class
- Amino Acid [EPC]
- Marketing Start
- 10/27/2020
Recall History
Central Admixture Pharmacy Services, Inc.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Central Admixture Pharmacy Services, Inc.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Central Admixture Pharmacy Services, Inc.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services, Inc.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
Central Admixture Pharmacy Services, Inc.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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…
Dosage & Administration
DOSAGE AND ADMINISTRATION The objective of nutritional management of infants and young pediatric patients is the provision of sufficient amino acid and caloric support for protein synthesis and growth. The total daily dose of TrophAmine® (Amino Acid Injection) depends on daily protein requirements and on the patient’s metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient’s fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response. Recommendations for allowances of protein in infant nutrition have ranged from 2 to 4 grams of protein per kilogram of body weight per day (2 to 4 g/kg/day). Suskind RM: Textbook of Pediatric Nutrition, Raven Press, New York, 1981. The recommended dosage of TrophAmine® is 2 to 2.5 grams of amino acids per kilogram of body weight per day (2 to 2.5 g/kg/day) for infants up to 10 kilograms. For infants and young pediatric patients larger than 10 kilograms, the total dosage of amino acids should include the 20 to 25 grams…
Warnings
WARNINGS Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide content, serum osmolalities, blood cultures, and blood ammonia levels. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Administration of amino acids in the presenc…
Contraindications
CONTRAINDICATIONS TrophAmine® is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism, including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia, or hypersensitivity to one or more amino acids present in the solution.
Drug Interactions
Drug Interactions Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Adverse Reactions
ADVERSE REACTIONS See “ WARNINGS ” and “ Special Precautions for Central Venous Nutrition . ” Reactions reported in clinical studies as a result of infusion of the parenteral fluid were water weight gain, edema, increase in BUN, and mild acidosis. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. Local reaction at the infusion site, consisting of a warm sensation, erythema, phlebitis and thrombosis, have been reported with peripheral amino acid infusions, especially if other substances are also administered through the same site. If electrolyte supplementation is required during peripheral infusion, it is recommended that additives be administered throughout the day in order to avoid possible venous irritation. Irritating additive medications may require injection at another site and should not be added directly to the amino acid infusate. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels…
Frequently Asked Questions
What is TrophAmine used for?
TrophAmine contains ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE. It is a solution taken intravenous. Consult your doctor for specific uses.
Is TrophAmine a controlled substance?
TrophAmine is not classified as a controlled substance by the DEA.
What is the generic name for TrophAmine?
The generic name for TrophAmine is ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE. There are no other listed brand versions of ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, and TAURINE.
What is the NDC code for TrophAmine .24 g/100mL?
The NDC (National Drug Code) for TrophAmine .24 g/100mL is 0264-1933, listed by B. Braun Medical Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)