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Aminosyn II Injection

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Aminosyn II Injection

Aminosyn® II
(an amino acid) Injection

Pharmacy Bulk Package—Not For Direct Infusion.
Flexible Plastic Container

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
Phenylalanine structural formula illustration
CH2CH(NH2)COOH
Threonine CH3CH(OH)CH(NH2)COOH
Tryptophan
Tryptophan structural formula illustration
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
Histidine structural formula illustration
CH2CH(NH2)COOH
Proline
Proline structural formula illustration
Serine HOCH2CH(NH2)COOH
N-Acetyl-L-Tyrosine
N-Acetyl-L-Tyrosine structural formula illustration

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.

Last reviewed on RxList: 1/14/2009
This monograph has been modified to include the generic and brand name in many instances.

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