B. Braun Medical Inc
Product Description:TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55
Status:Ongoing
City:Irvine
State:CA
Country:US
Voluntary/Mandated:Voluntary: Firm Initiated
Initial Firm Notification:Letter
Distribution Pattern:Nationwide, Puerto Rico and Spain
Classification:Class I
Product Quantity:17,544 units
Reason For Recall:Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Recall Initiation Date:20131121
Report Date:20140507

Trophamine

Trophamine

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Questions & Answers

Side Effects & Adverse Reactions

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.

This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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).

History

There is currently no drug history available for this drug.

Other Information

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 <3

Trophamine Manufacturers


  • B. Braun Medical Inc.
    Trophamine (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.]

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