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Aminosyn Sulfite Free

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Aminosyn Sulfite Free

Aminosyn®
Sulfite-Free

A CRYSTALLINE AMINO ACID SOLUTION
Flexible Plastic Container

DRUG DESCRIPTION

Aminosyn®, Sulfite-Free, (a crystalline amino acid solution) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn is oxygen sensitive. Five different formulations are available:

Aminosyn Formulations Essential Amino Acids (mg/100 mL)

Aminosyn 3.5% 5% 7% 8.5% 10%
Isoleucine 252 360 510 620 720
Leucine 329 470 660 810 940
Lysine (acetate)* 252 360 510 624 720
Methionine 140 200 280 340 400
Phenylalanine 154 220 310 380 440
Threonine 182 260 370 460 520
Tryptophan 56 80 120 150 160
Valine 280 400 560 680 800
*Amount cited is for Lysine alone and does not include the acetate salt.

Nonessential Amino Acids (mg/100 mL)

Aminosyn 3.5% 5% 7% 8.5% 10%
Alanine 448 640 900 1100 1280
Arginine 343 490 690 850 980
Histidine 105 150 210 260 300
Proline 300 430 610 750 860
Serine 147 210 300 370 420
Tyrosine 31 44 44 44 44
Glycine 448 640 900 1100 1280

Electrolytes (mEq/Liter)

Aminosyn 3.5% 5% 7% 8.5% 10%
Sodium (Na+) None None None None None
Potassium (K+) None None None None None
Chloride (Cl) None None None 35a None
Acetate (C2H3O2–)b 51 86 105 90 147
a Includes chloride from HCl added for processing and pH adjustment.
b Includes acetate from acetic acid used in processing and from Lysine acetate.

Product Characteristics

Aminosyn 3.5% 5% 7% 8.5% 10%
Protein Equivalent (approx. grams/liter) 35 50 70 85 100
Total Nitrogen (grams/liter) 5.5 7.86 11.00 13.4 15.72
Osmolarity (mOsmol/liter) 322 462 655 802 932
pH 5.2 5.2 5.2 5.2 5.2
Range (4.5 –6.0c) (4.5 – 6.0c) (4.5 – 6.0c) (4.5 – 6.0d) (4.5 – 6.0c)
c Adjusted with acetic acid.
d Adjusted with acetic acid and hydrochloric acid.

The formulas for the individual amino acids present in Aminosyn are as follows:

Essential Amino Acids

Isoleucine (C6H13NO2)
Leucine (C6H13NO2)
Lysine Acetate (C6H14N2O2 • CH3COOH)
Methionine (C5H11NO2S)
Phenylalanine (C9H11NO2)
Threonine (C4H9NO3)
Tryptophan (C11H12N2O2)
Valine (C5H11NO2)

Nonessential Amino Acids

Alanine (C3H7NO2)
Arginine (C6H14N4O2)
Histidine (C6H9N3O2)
Proline (C5H9NO2)
Serine (C3H7NO3)
Tyrosine (C9H11NO3)
Glycine (C2H5NO2)

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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