Aminosyn II 4.25% in 25% Dextrose

DRUG DESCRIPTION

Upper Chamber: Aminosyn II 8.5%, an amino acid injection, 500 mL.

Aminosyn II 8.5% is a sterile, nonpyrogenic solution for intravenous infusion.
The formulation is described in the table below.

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. 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 the lower chamber will be 4.25% 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
	Upper Chamber	Lower Chamber	Admixture
Dextrose, hydrous (g)		50	25
Essential Amino Acids (mg)
Isoleucine	561		280
Leucine	850		425
Lysine (as acetate salt)*	893		446
Methionine	146		73
Phenylalanine	253		126
Threonine	340		170
Tryptophan	170		85
Valine	425		212
Nonessential Amino Acids (mg)
Alanine	844		422
Arginine	865		432
L-Aspartic Acid	595		298
L-Glutamic Acid	627		314
Histidine	255		128
Proline	614		307
Serine	450		225
N-Acetyl-L-Tyrosine	230		115
Glycine	425		212
Total Amino Acids (g)	8.5		4.25
Protein Equivalent (g)	8.5		4.25
Total Nitrogen (g)	1.3		0.65
Electrolytes (mEq/liter)
Sodiuma (Na+)	38		19
Acetateb(C2H3O2–)	61.1		30.6
Sodium hydrosulfite (mg/100 mL)	60		30
Osmolarity mOsmol/liter (actual)	780	1997	1522
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 the 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	CH2CH(NH2)COOH
Threonine	CH3CH(OH)CH(NH2)COOH
Tryptophan	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	HOOCCH2CH(NH2)COOH
L-Glutamic Acid	HOOC(CH2)2CH(NH2)COOH
Glycine	H2NCH2COOH
Histidine	CH2CH(NH2)COOH
Proline
Serine	HOCH2CH(NH2)COOH
N-Acetyl-L-Tyrosine
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
•H₂O), 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.