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Aminosyn II Injection (Amino Acid Injection) - Summary

 
 



BOX WARNING

SPECIAL PRECAUTIONS FOR

CENTRAL INFUSIONS

ADMINISTRATION BY CENTRAL VENOUS CATHETER SHOULD BE

USED ONLY BY THOSE FAMILIAR WITH THIS TECHNIQUE AND

ITS COMPLICATIONS

 

SUMMARY

Upper Chamber: Aminosyn II 7%, an amino acid injection, 500 mL. Aminosyn II 7% is a sterile, nonpyrogenic solution for intravenous infusion. Lower Chamber: 50% Dextrose Injection, USP, 500 mL. 50% Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection.

Aminosyn II 3.5% in 25% Dextrose Injection is indicated for central vein infusion in the prevention of nitrogen loss and negative nitrogen balance in cases where (a) the gastrointestinal tract by the oral, gastrostomy or jejunostomy route cannot or should not be used, (b) gastrointestinal absorption of nutrients is impaired or (c) metabolic requirements for protein and calories are substantially increased as with extensive burns and (d) morbidity and mortality may be reduced by replacing amino acids lost from tissue breakdown, thereby preserving tissue reserves, as in acute renal failure. In such patients intravenous feeding for more than a few days would be expected.

The addition of supplemental electrolytes, will be required in accordance with the prescription of the attending physician.


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NEWS HIGHLIGHTS

Published Studies Related to Aminosyn II Injection (Amino Acid Injection)

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.

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Clinical Trials Related to Aminosyn II Injection (Amino Acid Injection)

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.

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.

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: 2013-02-10

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