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DRUG DESCRIPTION
Aminosyn® II (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulations are described
| Essential Amino Acids (mg/100 mL) | Aminosyn II | |
| 10% | 15% | |
| Isoleucine | 660 | 990 |
| Leucine | 1000 | 1500 |
| Lysine (acetate)* | 1050 | 1575 |
| Methionine | 172 | 258 |
| Phenylalanine | 298 | 447 |
| Threonine | 400 | 600 |
| Tryptophan | 200 | 300 |
| Valine | 500 | 750 |
| *Amount cited is for lysine alone and does not include the acetate. | ||
| Nonessential Amino Acids (mg/100 mL) | ||
| Alanine | 993 | 1490 |
| Arginine | 1018 | 1527 |
| L-Aspartic Acid | 700 | 1050 |
| L-Glutamic Acid | 738 | 1107 |
| Histidine | 300 | 450 |
| Proline | 722 | 1083 |
| Serine | 530 | 795 |
| N-Acetyl-L-Tyrosine | 270 | 405 |
| Glycine | 500 | 750 |
| Other Characteristics | ||
| Protein Equivalent (approx. grams/liter) | 100 | 150 |
| Total Nitrogen (grams/liter) | 15.3 | 23.0 |
| Osmolarity (mOsmol/liter, actual) | 870 | 1300 |
| pHa | 5.8 (5.0 –6.5) | 5.8 (5.0 –6.5) |
| Specific Gravity | 1.03 | 1.05 |
| Electrolytes (mEq/L) | ||
| Sodium (Na+)b | 39.8 | 58.1 |
| Acetate (C2H3O2–)c | 71.8 | 107.6 |
| Sodium Hydrosulfite(mg/100mL) | 20 | 20 |
| a Solution contains sodium hydroxide
for pH adjustment. b Figure includes Na+ from the antioxidant, sodium hydrosulfite and from the pH adjustor. c Includes acetate from lysine acetate. |
||
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts to affect the solution significantly.
Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
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 |
 |
The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture.