Aminosyn II 5% in 25% Dextrose


Upper Chamber: Contains 500 mL of Aminosyn II 10% (an amino acid injection) — a sterile, nonpyrogenic solution for intravenous infusion. The formulation is described in the table below.

Lower Chamber: Contains 500 mL of 50% Dextrose Injection, USP — a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection. The table below indicates the characteristics of this concentrated 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 lower chamber contains 5% amino acids in 25% 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
Dextrose, hydrous (g)   50 25
Essential Amino Acids (mg)
  Isoleucine 660   330
  Leucine 1000   500
  Lysine (as acetate salt)* 1050   525
  Methionine 172   86
  Phenylalanine 298   149
  Threonine 400   200
  Tryptophan 200   100
  Valine 500   250
Nonessential Amino Acids (mg)
  Alanine 993   496
  Arginine 1018   509
  L-Aspartic Acid 700   350
  L-Glutamic Acid 738   369
  Glycine 500   250
  Histidine 300   150
  Proline 722   361
  Serine 530   265
  N-Acetyl-L-Tyrosine 270   135
  Total Amino Acids (g) 10   5
  Protein Equivalent (g) 10   5
  Total Nitrogen (g) 1.53   0.77
Electrolytes (mEq/liter)
  Sodiuma(Na+) 44.4   22.2
  Acetateb(C2H3O2–) 71.8   35.9
  Sodium hydrosulfite (mg/100 mL) 60   30
Osmolarity mOsmol/liter (actual) 868 1997 1539
pH 5.8 4.3 5.8
rangec 5.0 to 6.5 3.2 to 6.5 5.0 to 6.5
*Amount cited is for lysine alone and does not include the acetate salt.
a Includes sodium from the pH adjustor (sodium hydroxide) and the antioxidant, sodium hydrosulfite.
b From lysine acetate.
c Contains 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 structural formula illustration
Threonine CH3CH(OH)CH(NH2)COOH
Tryptophan structural formula illustration
Valine (CH3)2CHCH(NH2)COOH
Nonessential Amino Acids
Alanine CH3CH(NH2)COOH
Arginine H2NC(NH)NH(CH2)3CH(NH2)COOH
L-Aspartic Acid HOOCCH2CH(NH2)COOH
L-Glutamic Acid HOOC(CH2)2CH(NH2)COOH
Glycine H2NCH2COOH
Histidine structural formula illustration
Proline structural formula illustration
N-Acetyl-L-Tyrosine structural formula illustration

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.

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