Aminosyn II 5
"On April 3, 2015, the U.S. District Court for the District of Massachusetts on behalf of the U.S. Food and Drug Administration has filed a consent decree of permanent injunction against Michael P. Ferry Inc., a dairy operation located in Westport"...
Aminosyn II 5% in 25% Dextrose
AMINOSYN® II 5%
in 25% Dextrose Injection
AN AMINO ACID INJECTION IN DEXTROSE INJECTION
NOTE: These solutions are hypertonic. See WARNINGS and PRECAUTIONS.
Nutrimix® Dual-chamber Flexible Container
The Upper Chamber Contains 500 mL of Aminosyn II 10% (An Amino Acid Injection)
The Lower Chamber Contains 500 mL of 50% Dextrose Injection, USP
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|
|Dextrose, hydrous (g)||50||25|
|Essential Amino Acids (mg)|
|Lysine (as acetate salt)*||1050||525|
|Nonessential Amino Acids (mg)|
|Total Amino Acids (g)||10||5|
|Protein Equivalent (g)||10||5|
|Total Nitrogen (g)||1.53||0.77|
|Sodium hydrosulfite (mg/100 mL)||60||30|
|Osmolarity mOsmol/liter (actual)||868||1997||1539|
|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|
|Lysine Acetate||H2N(CH2)4CH(NH2)COOH • CH3COOH|
|Nonessential Amino Acids|
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.
Last reviewed on RxList: 11/22/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Aminosyn II 5% in 25% Dextrose Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Weight Loss Wisdom
Get tips, recipes and inspiration.