TROPHAMINE- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochloride, histidine, tyrosine, n-acetyltyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, glutamic acid and taurine solution
B. Braun Medical Inc.
Protect from light until use.
DESCRIPTION
TrophAmine� (6% and 10% Amino Acid Injections) are sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids.
All amino acids designated USP are the "L"-isomer with the exception of Glycine USP, which does not have an isomer.
*
Holt LE, Snyderman SE: The amino acid requirements of infants. JAMA 1961; 175(2):124�127.
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Rigo J, Senterre J: Is taurine essential for the neonates? Biol Neonate 1977; 32:73�76.
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Gaull G, Sturman JA, R�ih� NCR: Development of mammalian sulfur metabolism: Absence of cystothionase in human fetal tissues. Pediatr Res 1972; 6:538�547.
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Provided as acetic acid and Iysine acetate.
Each 100 mL contains:
Essential Amino Acids 6% 10%
Isoleucine USP 0.49 g 0.82 g
Leucine USP 0.84 g 1.4 g
Lysine 0.49 g 0.82 g
(added as Lysine Acetate USP 0.69 g 1.2 g)
Methionine USP 0.20 g 0.34 g
Phenylalanine USP 0.29 g 0.48 g
Threonine USP 0.25 g 0.42 g
Tryptophan USP 0.12 g 0.20 g
Valine USP 0.47 g 0.78 g
Cysteine <0.014 g <0.016 g
(as Cysteine HCl∙H2 O USP <0.020 g <0.024 g)
Histidine USP * 0.29 g 0.48 g
Tyrosine * 0.14 g 0.24 g
(added as Tyrosine USP 0.044 g 0.044 g
and N-Acetyl-L-Tyrosine 0.12 g 0.24 g)
Nonessential Amino Acids
Alanine USP 0.32 g 0.54 g
Arginine USP 0.73 g 1.2 g
Proline USP 0.41 g 0.68 g
Serine USP 0.23 g 0.38 g
Glycine USP 0.22 g 0.36 g
L-Aspartic Acid 0.19 g 0.32 g
L-Glutamic Acid 0.30 g 0.50 g
Taurine �, � 0.015 g 0.025 g
Sodium Metabisulfite NF (as an antioxidant) <0.050 g <0.050 g
Water for Injection USP qs qs
pH adjusted with Glacial Acetic Acid USP pH: 5.5 (5.0�6.0)
Calc. Osmolarity (mOsmol/liter) 525 875
Total Amino Acids (grams/liter) 60 100
Total Nitrogen (grams/liter) 9.3 15.5
Protein Equivalent (grams/liter) 58 97
Electrolytes (mEq/liter)
Sodium 5 5
�Acetate (CH3 COO�) 54.4 97
Chloride <3 <3
CLINICAL PHARMACOLOGY
TrophAmine� provides a mixture of essential and nonessential amino acids as well as taurine and a soluble form of tyrosine, N-Acetyl-L-Tyrosine (NAT). This amino acid composition has been specifically formulated to provide a well tolerated nitrogen source for nutritional support and therapy for infants and young pediatric patients. When administered in conjunction with cysteine hydrochloride, TrophAmine� results in the normalization of the plasma amino acid concentrations to a profile consistent with that of a breast-fed infant.
The rationale for TrophAmine� (Amino Acid Injections) is based on the observation of inadequate levels of essential amino acids in the plasma of infants receiving total parenteral nutrition (TPN) using conventional amino acid solutions. The TrophAmine� formula was developed through the application of specific pharmacokinetic multiple regression analysis relating amino acid intake to the resulting plasma amino acid concentrations.
Clinical studies in infants and young pediatric patients who required TPN therapy showed that infusion of TrophAmine� with a cysteine hydrochloride admixture resulted in a normalization of the plasma amino acid concentrations. In addition, weight gains, nitrogen balance, and serum protein concentrations were consistent with an improving nutritional status.
When infused with hypertonic dextrose as a calorie source, supplemented with cysteine hydrochloride, electrolytes, vitamins, and minerals, TrophAmine� provides total parenteral nutrition in infants and young pediatric patients, with the exception of essential fatty acids.
It is thought that the acetate from lysine acetate and acetic acid, under the conditions of parenteral nutrition, does not impact net acid-base balance when renal and respiratory functions are normal. Clinical evidence seems to support this thinking; however, confirmatory experimental evidence is not available.
The amounts of sodium and chloride present in TrophAmine� are not of clinical significance.
The addition of cysteine hydrochloride will contribute to the chloride load.
The electrolyte content of any additives that are introduced should be carefully considered and included in total input computations.
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.
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.
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.
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 Injections) 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 (2.0 to 4.0 g/kg/day).1 The recommended dosage of TrophAmine� is 2.0 to 2.5 grams of amino acids per kilogram of body weight per day (2.0 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/day for the first 10 kg of body weight plus 1.0 to 1.25 g/day for each kg of body weight over 10 kilograms.
Typically, TrophAmine� is admixed with B. Braun's 50% or 70% Dextrose Injection USP supplemented with electrolytes and vitamins and administered continuously over a 24 hour period.
Total daily fluid intake should be appropriate for the patient's age and size. A fluid dose of 125 mL per kilogram body weight per day is appropriate for most infants on TPN. Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance.
Cysteine is considered to be an essential amino acid in infants and young pediatric patients. An admixture of cysteine hydrochloride to the TPN solution is therefore recommended. Based on clinical studies, the recommended dosage is 1.0 mmole of L-cysteine hydrochloride monohydrate per kilogram of body weight per day.
In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose solutions are abruptly discontinued.
Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN.
The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate salts to provide bicarbonate precursor. The electrolyte content of TrophAmine� must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.
Appropriate vitamins, minerals and trace elements should also be provided.
