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Aminosyn II 3.5

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Aminosyn II 3.5% in 5% Dextrose

AMINOSYN® II 3.5%
in 5% 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 500 mL of Aminosyn II 7% (An Amino Acid Injection)
The Lower Chamber Contains 500 mL of 10% Dextrose Injection, USP

DRUG DESCRIPTION

Upper Chamber: Aminosyn II 7%, an amino acid injection, 500 mL.

Aminosyn II 7% is a sterile, nonpyrogenic solution for intravenous infusion. The formulation is described in the table below.

Lower Chamber: 10% Dextrose Injection, USP, 500 mL.

10% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection. The table below indicates the characteristics of this solution.

The container must be used only after removing the clamp and thoroughly mixing the contents of the two chambers. The solution resulting from mixing the contents of the upper and the lower chamber will be 3.5% amino acids with 5% dextrose. Mixing the contents of the upper and lower chambers yields a concentrated source of amino acids and carbohydrate calories for intravenous infusion. Headspace contains Nitrogen gas. The composition of this admixture is described in the table below.

  Solution Composition per 100 mL
Upper
Chamber
Lower
Chamber
Admixture
Dextrose, hydrous (g)   10 5
Essential Amino Acids (mg)
   Isoleucine 462   231
   Leucine 700   350
   Lysine (as acetate salt)* 735   368
   Methionine 120   60
   Phenylalanine 209   104
   Threonine 280   140
   Tryptophan 140   70
   Valine 350   175
Nonessential Amino Acids (mg)
   Alanine 695   348
   Arginine 713   356
   L-Aspartic Acid 490   245
   L-Glutamic Acid 517   258
   Histidine 210   105
   Proline 505   252
   Serine 371   186
   N-Acetyl-L-Tyrosine 189   94
   Glycine 350   175
Total Amino Acids (g) 7   3.5
Protein Equivalent (g) 7   3.5
Total Nitrogen (g) 1.07   0.54
Electrolytes (mEq/liter)
   Sodiuma (Na+) 36   18
   Acetateb (C2H3O2–) 50.3   25.2
   Sodium hydrosulfite added    (mg/100 mL) 60.0   30.0
   Osmolarity mOsmol/liter    (actual) 647 546 585
   pH 5.8 4.3 5.8
   range 5.0 to 6.5c 3.2 to 6.5 5.0 to 6.5
*Amount cited is for lysine alone and does not include acetate salt.
a Includes sodium from the pH adjustor sodium hydroxide and the antioxidant, sodium hydrosulfite.
b Includes acetate from lysine acetate.
c May contain sodium hydroxide for pH adjustment.

The formulas for the individual amino acids 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)COOH
Arginine H2NC(NH)NH(CH2)3CH(NH2)COOH
L-Aspartic Acid HOOCCH2 CH(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
a Includes sodium from the pH adjustor sodium hydroxide and the antioxidant, sodium hydrosulfite.
b Includes acetate from lysine acetate.
c May contain sodium hydroxide for pH adjustment.

Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6•H20), a hexose sugar freely soluble in water.

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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