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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)

Severe Burns May Trigger Dangerous Shifts in Gut Germs
Source: MedicineNet Burns Specialty [2015.07.09]
Title: Severe Burns May Trigger Dangerous Shifts in Gut Germs
Category: Health News
Created: 7/8/2015 12:00:00 AM
Last Editorial Review: 7/9/2015 12:00:00 AM

Burns (First Aid)
Source: MedicineNet Hyperkalemia Specialty [2015.02.20]
Title: Burns (First Aid)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 2/20/2015 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 [Enrolling by invitation]
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.

Dietary Intake and Circulating Levels of Branched Chain Amino Acids [Completed]
The investigators are conducting this research study to find out if eating low or high levels of specific amino acids changes the levels of these same amino acids in the blood. Amino acids are the building blocks of protein that are normally found in food. The amino acids the investigators are studying are called branched chain amino acids. The investigators will look at the levels (amount) of branched chain amino acids in blood before and after consumption of specially prepared meals. The investigators hypothesize that circulating branch chain amino acid (BCAA) levels will be lower following a low BCAA-content diet compared with a high BCAA-content diet.

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

Exercise and Branched Chain Amino Acids (BCAA)Requirements in Older Men [Not yet recruiting]
Likely, branched chain amino acid (BCAA) requirements are increased in older strength-trained (ST) individuals. If so, supplementation in this group will maximize muscle protein synthesis (MPS) and minimize loss of muscle with age (sarcopenia).

Characterizing the Incretin Effect of Amino Acids and Defining GLP-1 Role on Skeletal Muscle [Recruiting]
This study has two protocols the aims of which are: 1. To identify age-related effects of AA on incretin secretion and whether and to what extent AA exhibit a true incretin effect (gut- mediated increases in plasma insulin) in younger individuals. (Protocol 1) 2. To define the extra-pancreatic ''novel'', insulin independent effects of glucagon like peptide-1 (GLP-1) on postprandial muscle protein and glucose metabolism and microvascular blood flow. (Protocol 2)

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Page last updated: 2015-07-09

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