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 |  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 | HOOCCH2 CH(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•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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