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Aminosyn II Injection (Amino Acid Injection) - Description and Clinical Pharmacology

 
 



NOTE: These solutions are hypertonic. See WARNINGS and PRECAUTIONS.

Nutrimix ® Dual-chamber Flexible Container

The Upper Chamber Contains 500 mL of Aminosyn II 7%

(An Amino Acid Injection)

The Lower Chamber Contains 500 mL of 50% Dextrose Injection, USP

Rx only

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: 50% Dextrose Injection, USP, 500 mL.

50% Dextrose Injection, USP (concentrated dextrose in water) is 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 the lower chamber will be 3.5% 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

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

*Amount cited is for lysine alone and does not include the acetate salt.

Upper Chamber

Lower

Chamber

Admixture

Electrolytes (mEq/liter)

Sodium a (Na+)

36

18

Acetate b (C2H3O2)

50.3

25.2

Sodium hydrosulfite (mg/100 mL)

60

30

Osmolarity mOsmol/liter (actual)

647

1997

1515

pH

5.8

4.3

5.8

range

5.0 to 6.5 c

3.2 to 6.5

5.0 to 6.5

The formulas for the individual amino acids present are as follows:

_______________________________________________________________________________

aIncludes sodium from the pH adjustor sodium hydroxide and the antioxidant, sodium hydrosulfite.

bIncludes acetate from lysine acetate.

cMay 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.

CLINICAL PHARMACOLOGY

The Aminosyn II 3.5% in 25% Dextrose Injection admixture, obtained upon mixing thoroughly the contents of the two chambers, provides carbohydrate calories and crystalline amino acids to stimulate protein synthesis, to limit protein catabolism, to minimize liver glycogen depletion and to promote wound healing. The infusion of this mixture through a central venous line should be considered to meet protein and calorie requirements for patients requiring prolonged total parenteral nutrition. I.V. lipids may be infused simultaneously to provide adequate calories, if desired.

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