|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|
|Voluntary/Mandated:||Voluntary: Firm Initiated|
|Initial Firm Notification:||Letter|
|Distribution Pattern:||Nationwide, Puerto Rico and Spain|
|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|
Get an alert when a recall is issued.
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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
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 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.
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).
There is currently no drug history available for this drug.
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*||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|