Trophamine (Amino Acid Injection) - Description and Clinical Pharmacology

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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.

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 1	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 2 , 3	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
4 Acetate (CH3COO–)	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.