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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)

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.

Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis [Recruiting]
Malnutrition, including muscle wasting commonly occurs in children with cystic fibrosis (CF), negatively influencing their quality of life and survival. At the time of a diagnosis of CF, severe protein deficits can already be present. It is important to get CF children fed adequately to prevent that their condition becomes worse or that recovery takes longer. Oral supplementation trials showed that gains in lean body mass are difficult to achieve in CF unless specific metabolic abnormalities are targeted. However, the specific needs for certain food components are not clear yet in children that are ill. Therefore, more information is necessary on the need for protein and certain amino acids in children with CF. Previous studies support the concept of essential amino acids (EAA) as an anabolic stimulus in the young and elderly and in insulin resistant states. Until yet no information is present on the anabolic effects of EAA in CF.

It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically designed to stimulate protein anabolism will target the metabolic alterations of pediatric subjects with CF. In the present proposal, the acute metabolic effects of this high leucine essential amino acids mixture will be examined in pediatric subjects with CF and compared to that of a regular balanced total mixture of essential and non-essential amino acids. The principal endpoints will be the extent of stimulation of whole body protein synthesis as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism, and the reduction in endogenous protein breakdown. Both endpoints will be assessed by isotope methodology which is thought to be the reference method.

Modulation of Systemic Inflammatory Response in Critically Ill Children After Glutamine Supplementation [Recruiting]
This study aims to describe the use of glutamine supplementation in the modulation of inflammatory response in critically ill pediatric patients and to determine if this decrease leads to clinical improvement in morbidity and mortality in these patients. Thus, these patients' diet could be supplemented with glutamine in order to improve their evolution.

Hypothesis:

From the data obtained in the study of the literature the investigators consider that:

Critically ill patients have a deficit of glutamine either because of an increase in its consumption or a decrease in its availability, and therefore blood glutamine levels are low.

Critically ill patients have elevated blood levels of pro-inflammatory substances (IL-6).

In these patients tissue lesion inhibitors (HSP-70) in the blood are decreased. The administration of glutamine supplements to these patients decreases oxidative stress due to the increase in HSP-70.

Inflammation inhibitory substances (IL-10) in the blood are decreased in these patients.

The administration of glutamine supplements in these patients increase IL-10 levels.

Glutamine supplements decrease the inflammatory response with a decrease in IL-6 levels.

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Page last updated: 2013-02-10

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