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DRUG DESCRIPTION
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 | |||
| Upper Chamber |
Lower Chamber |
Admixture | |
| 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 |
 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 |
 |
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.