TrophAmine
TROPHAMINE- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, cysteine hydrochloride, histidine, tyrosine, acetyl l-tyrosine, alanine, arginine, proline, serine, glycine, aspartic acid, glutamic acid and taurine solution
B. Braun Medical Inc.
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION
Protect from light.
DESCRIPTION
TrophAmine® (10% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution 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 | 10% |
| Isoleucine USP | 0.82 g |
| Leucine USP | 1.4 g |
| Lysine | 0.82 g |
| (added as Lysine Acetate USP | 1.2 g) |
| Methionine USP | 0.34 g |
| Phenylalanine USP | 0.48 g |
| Threonine USP | 0.42 g |
| Tryptophan USP | 0.2 g |
| Valine USP | 0.78 g |
| Cysteine | <0.016 g |
| (as Cysteine HCl∙H2 O USP | <0.024 g) |
| Histidine USP * | 0.48 g |
| Tyrosine * | 0.24 g |
| (added as Tyrosine USP | 0.044 g |
| and N-Acetyl-L-Tyrosine | 0.24 g) |
| Nonessential Amino Acids | |
| Alanine USP | 0.54 g |
| Arginine USP | 1.2 g |
| Proline USP | 0.68 g |
| Serine USP | 0.38 g |
| Glycine USP | 0.36 g |
| L-Aspartic Acid | 0.32 g |
| L-Glutamic Acid | 0.5 g |
| Taurine †‡ | 0.025 g |
| Water for Injection USP | qs |
| pH adjusted with Glacial Acetic Acid USPpH: 5.5 (5.0–6.0) | |
| Calc. Osmolarity (mOsmol/liter) | 866 |
| Total Amino Acids (grams/liter) | 100 |
| Total Nitrogen (grams/liter) | 15.5 |
| Protein Equivalent (grams/liter) | 97 |
| Electrolytes (mEq/liter) | |
| §Acetate (CH3 COO–) | 96.2 |
| Chloride | <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 Injection) 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 amount of chloride present in TrophAmine® is 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.
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).
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.
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 presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.
Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the solutions.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
Hyperammonemia is of special significance in infants as its occurrence in the syndrome caused by genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation. This reaction appears to be dose related and is more likely to develop during prolonged therapy. It is essential that blood ammonia be measured frequently in infants. The mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function.
Conservative doses of amino acids should be given, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient’s clinical status reevaluated.
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