SPL UNCLASSIFIED SECTION
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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. † Rigo J, Senterre J: Is taurine essential for the neonates? Biol Neonate 1977; 32:73–76. ‡ Gaull G, Sturman JA, Räihä NCR: Development of mammalian sulfur metabolism: Absence of cystothionase in human fetal tissues. Pediatr Res 1972; 6:538–547. § 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∙H2O 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 (CH3COO–) 54.4 97
Chloride <3 <3CLOSE
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 e |
