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Aminosyn II in Dextrose Injection

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Aminosyn II in Dextrose

Aminosyn® II
in Dextrose Injection

AN AMINO ACID INJECTION IN DEXTROSE INJECTION
NOTE: These solutions are hypertonic. See WARNINGS and PRECAUTIONS.
Nutrimix® Dual-chamber Flexible Container
The Upper Chamber Contains Aminosyn II (An Amino Acid Injection)
The Lower Chamber Contains Dextrose Injection, USP

DRUG DESCRIPTION

Upper Chamber: Aminosyn II.

Aminosyn II (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion.

Lower Chamber: Dextrose Injection, USP.

Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection.

The container must be used only after opening the clamp and thoroughly mixing the contents of the two chambers. Mixing the contents of the upper and lower chamber yields a concentrated source of amino acids and carbohydrate calories for intravenous infusion. Headspace contains Nitrogen gas. The composition of these admixtures is described in the table below.

SOLUTION COMPOSITION BEFORE COMBINATION

UPPER CHAMBER (500 mL) Amino Acid Concentrations 8.5%
Essential Amino Acids (mg/100 mL)
Isoleucine 561
Leucine 850
Lysine (as acetate salt)* 893
Methionine 146
Phenylalanine 253
Threonine 340
Tryptophan 170
Valine 425
  Amino Acid Concentrations 8.5%
Nonessential Amino Acids (mg/100 mL)
Alanine 844
Arginine 865
L-Aspartic Acid 595
L-Glutamic Acid 627
Glycine 425
Histidine 255
Proline 614
Serine 450
N-Acetyl-L-Tyrosine 230
  Amino Acid Concentrations 8.5%
Electrolytes (mEq/L)
Sodiuma(Na+) 38
Acetateb(C2H3O2–) 61.1
Sodium Hydrosulfite (Na2S2O4) added (mg/100 mL) 60
Other Characteristics
Osmolarity (actual mOsmol/L) 780
pHc 5.8
(range) 5.0 – 6.5
Total Amino Acids (g/L) 85
Protein Equivalent (g/L) 85
Total Nitrogen (g/L) 13.0
*Amount cited is for lysine alone and does not include acetate salt.
a From the antioxidant, sodium hydrosulfite, and from the pH adjustor, sodium hydroxide.
b From lysine acetate.
c May contain sodium hydroxide for pH adjustment.

SOLUTION COMPOSITION BEFORE COMBINATION

LOWER CHAMBER (500 mL)
Dextrose Injection, USP 20% 40%
Dextrose, hydrous (g/100 mL) 20 40
Energy (kcal/100 mL) 68 136
Osmolarity (actual mOsmol/L) 934 1740
pH 4.1 4.2
(range) 3.2 – 6.5 3.2 – 6.5

SOLUTION COMPOSITION AFTER COMBINATION (1000 mL)

  Amino Acid Concentrations
4.25%
Essential Amino Acids (mg/100 mL)
  Isoleucine 280
  Leucine 425
  Lysine (as acetate salt)* 446
  Methionine 73
  Phenylalanine 126
  Threonine 170
  Tryptophan 85
  Valine 212
Nonessential Amino Acids (mg/100 mL)
  Alanine 422
  Arginine 432
  L-Aspartic Acid 298
  L-Glutamic Acid 314
  Glycine 212
  Histidine 128
  Proline 307
  Serine 225
  N-Acetyl-L-Tyrosine 115
Electrolytes (mEq/L)  
  Aminosyn II (%)/Dextrose (%) 4.25/20 4.25/10
  Sodiuma (Na+) 19 19
  Acetateb (C2H3O2-) 30.6 30.6
  Sodium Hydrosulfite (Na2S2O4) added (mg/100 mL) 30 30
Other Characteristics    
  Dextrose, hydrous (g/100 mL) 20 10
  Osmolarity (actual mOsmol/L) 1295 894
  pHc 5.8 5.8
  (range) 5.0 – 6.5 5.0 – 6.5
  Total Amino Acids (g/L) 42.5 42.5
  Protein Equivalent (g/L) 42.5 42.5
  Total Nitrogen (g/L) 6.5 6.5
*Amount cited is for lysine alone and does not include acetate salt.
a From the antioxidant, sodium hydrosulfite, and from the pH adjustor, sodium hydroxide.
b From lysine acetate.
c May contain sodium hydroxide for pH adjustment.

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

Essential Amino Acids
Isoleucine CH3CH2CH(CH3)CH(NH2)COOH
Leucine (CH3)2CHCH2CH(NH2)COOH
Lysine Acetate H2N(CH2)4CH(NH2)COOH • CH3COOH
Methionine CH3S(CH2)2CH(NH2)COOH
Phenylalanine
Phenylalanine structural formula illustration
CH2CH(NH2)COOH
Threonine CH3CH(OH)CH(NH2)COOH
Tryptophan
Tryptophan structural formula illustration
CH2CH(NH2)COOH
Valine (CH3)2CHCH(NH2)COOH
Nonessential Amino Acids
Alanine CH3CH(NH2)C H
Arginine H2NC(NH)NH(CH2)3CH(NH2)C H
L-Aspartic Acid HOOCCH2CH(NH2)COOH
L-Glutamic Acid HOOC(CH2)2CH(NH2)COOH
Glycine H2NCH2COOH
Histidine
Histidine structural formula illustration
CH2CH(NH2)COOH
Proline
Proline structural formula illustration
Serine HOCH2CH(NH2)COOH
N-Acetyl-L-Tyrosine
N-Acetyl-L-Tyrosine structural formula illustration

Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6• H2O), a hexose sugar freely soluble in water.

Dextrose Structural Formula Illustration

The flexible plastic container is fabricated from a specially formulated nonplasticized thermoplastic co-polyester (CR3). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.

Last reviewed on RxList: 1/14/2009
This monograph has been modified to include the generic and brand name in many instances.

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