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Trophamine (Amino Acid Injection) - Summary

 
 



TROPHAMINE SUMMARY

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.

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 to 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).


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NEWS HIGHLIGHTS

Media Articles Related to Trophamine (Amino Acid Injection)

Serious Childhood Burns Tied to Long-Term Mental Health Risks
Source: MedicineNet Burns Specialty [2014.09.05]
Title: Serious Childhood Burns Tied to Long-Term Mental Health Risks
Category: Health News
Created: 9/4/2014 4:36:00 PM
Last Editorial Review: 9/5/2014 12:00:00 AM

Survivors of childhood burns at increased risk of mental illness
Source: Dermatology News From Medical News Today [2014.09.02]
Adults who have been hospitalized for a burn as a child experience higher than usual rates of depression and suicidal thoughts, according to new research at the University of Adelaide.

Tips for Beating BBQ Burns
Source: MedicineNet Burns Specialty [2014.07.23]
Title: Tips for Beating BBQ Burns
Category: Health News
Created: 7/22/2014 5:36:00 PM
Last Editorial Review: 7/23/2014 12:00:00 AM

Burns (First Aid)
Source: MedicineNet Hyperkalemia Specialty [2013.12.20]
Title: Burns (First Aid)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/20/2013 12:00:00 AM

Burn Risk Seen with Topical Pain Relievers
Source: MedPage Today Product Alert [2012.09.13]
WASHINGTON -- The FDA warned Thursday of the risks of rare but serious chemical burns with certain over-the-counter topical pain relievers, including Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum.

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Published Studies Related to Trophamine (Amino Acid Injection)

Skeletal muscle is anabolically unresponsive to an amino acid infusion in pediatric burn patients 6 months postinjury. [2011.03]
OBJECTIVE: To evaluate leg muscle, whole-body muscle, and whole-body nonmuscle protein response to anabolic signaling of amino acids in pediatric burn patients at 6 months after injury. BACKGROUND: Burn injury is associated with a catabolic state persisting years after the injury. The tissue response to nutritional signaling (eg, amino acids) plays a critical role in tissue protein net balance via coordination of protein synthesis and breakdown mechanisms... CONCLUSION: In pediatric burn patients at 6 months postinjury, leg muscle protein net deposition is unresponsive to amino acid infusion; and whole-body protein breakdown is significantly higher than in the control group.

Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response. [2010.08.25]
PI-2301 is an immunomodulator that could be an alternative therapy for MS. A placebo-controlled, multiple-ascending dose, double-blind study was performed in patients with secondary-progressive MS... MRI data indicated a non-significant trend for a reduction of lesion numbers in subjects treated with 1 and 3 mg PI-2301.

Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response. [2010]
PI-2301 is an immunomodulator that could be an alternative therapy for MS. A placebo-controlled, multiple-ascending dose, double-blind study was performed in patients with secondary-progressive MS... The most common adverse event was transient injection site reactions.

Effects of dimethylaminoethanol pyroglutamate (DMAE p-Glu) against memory deficits induced by scopolamine: evidence from preclinical and clinical studies. [2009.12]
RATIONALE: Dimethylaminoethanol pyroglutamate (DMAE p-Glu) is a compound resulting from the reaction between dimethylaminoethanol (an indirect precursor of acetylcholine) and pyroglutamic acid (a cyclic derivative of glutamic acid having procholinergic properties and promnesic effects in both animals and man). OBJECTIVES: The present study undertook preclinical and clinical evaluations to test a potential therapeutic utility for DMAE p-Glu in cognitive impairments related to central cholinergic deficit... CONCLUSION: These results indicate that DMAE p-Glu reduces the deleterious effect of scopolamine on long-term memory in healthy volunteers and suggest that DMAE p-Glu might be effective in reducing memory deficits in patients with cognitive impairment.

[Investigation on treatment of fetal growth restriction by salvia injection combined with composite amino acid] [2009.01]
OBJECTIVE: To explore the effect of salvia injection (SI) combined with composite amino acid (CAA) in treating fetal growth restriction (FGR)... CONCLUSION: The combined treatment with SI and CAA on FGR could improve the condition of the fetus.

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Clinical Trials Related to Trophamine (Amino Acid Injection)

Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates [Not yet recruiting]
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene solution develop TPN-associated cholestasis in a smaller proportion than those who received Trophamine solution.

Growth and Plasma Amino Acids in Infants With CMPA and Treated With a Newly Innovated Amino Acid Formula [Not yet recruiting]
The purpose of this study is to determine growth and protein status of infants with cow's milk protein allergy and treated with a newly innovated amino acid formula compared to those with a commercial amino acid formula.

Local Effects of Amino Acids, Leucine and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg [Recruiting]
Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%. Animal studies also show that after administrating 3-hydroxybutyrate (3-OHB), cardiac output increase, and O2 consumption decrease. Humane studies show 10% increase in protein synthesis and 30% decrease in protein degradation after administration of 3-OHB.

Objectives: Compared to saline, an amino acid infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will be further amplified by leucine and 3-OHB enrichment and will include distinct alterations in muscle signal events, in particular mTOR.

Methods: n = 4 x 8 healthy male subjects are equipped with catheters in aa. femorales and vv. femorales bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglucaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The 4 different studies contain continues saline infusion compared to either (i) amino acids (Vamin), (ii) Vamin + leucine, (iii) Vamin + 3-OHB or (iiii) Vamin + leucine + 3-OHB.

Perspectives: This study elucidates whether infusion of aminoacids, leucin and 3-hydroxybutyrate can diminish protein loss and thereby potentially improve the nutrition of all critically ill patients.

Gut Hormones After Oral Versus Intravenous Amino Acids [Recruiting]
The study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion.

Amino Acid Supplementation in Recovery From Traumatic Brain Injury [Recruiting]
Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It has been called the "signature wound" of the Iraq war because of its frequency among troops. TBI is associated with many chronic disabilities. Physical alterations include reduced exercise tolerance and profound muscle weakness, whereas psychological alterations include diminished sense of well-being, depression, fatigue and anxiety. Muscle and brain tissues rely upon circulating blood amino acids as precursors for metabolic functions. The investigators have shown that even one year after injury, plasma valine, an essential amino acid (EAA), was markedly reduced in patients with TBI compared to healthy controls. The investigators speculate that low plasma valine concentration contributes to chronic fatigue after TBI, since valine and tryptophan compete for the same transporter into the brain, and a low plasma valine concentration will allow more tryptophan to be transported. As a consequence, increased brain tryptophan will increase serotonin production, which may significantly contribute to the development of fatigue. Thus, the investigators will test if restoring valine concentration in persons with TBI may reduce fatigue perception and improve physical and neuropsychological function. Further, the investigators have previously shown that EAA intake has an anabolic effect in healthy young and elderly individuals. However, no data are currently available in persons recovering from TBI. Thus,the investigators will also test if EAA and/or valine can improve muscle mass in patients with TBI.

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Page last updated: 2014-09-05

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