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Aminosyn II

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Aminosyn II 8.5%

Aminosyn® II 8.5% WITH ELECTROLYTES
Sulfite-Free

AN AMINO ACID INJECTION WITH ELECTROLYTES
Flexible Plastic Container

DRUG DESCRIPTION

Aminosyn® II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino acid injection with electrolytes) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II 8.5% (amino acid injection with electrolytes) WITH ELECTROLYTES is oxygen sensitive. The following formulation is available:

Essential Amino Acids (mg/100 mL)

Isoleucine 561
Leucine 850
Lysine (acetate)* 893
Methionine 146
Phenylalanine 253
Threonine 340
Tryptophan 170
Valine 425
*Amount cited is for lysine alone and does not include the acetate salt.

Nonessential Amino Acids (mg/100 mL)

Alanine 844
Arginine 865
L-Aspartic Acid 595
L-Glutamic Acid 627
Histidine 255
Proline 614
Serine 450
N-Acetyl-L-Tyrosine 230
Glycine 425

Product Characteristics

Protein Equivalent (approx. g/liter) 85
Total Nitrogen (g/liter) 13.0
Osmolarity (mOsmol/L) 920
pHa 5.8
range 5.0 - 6.5
aContains sodium hydroxide for pH adjustment.

Electrolytes (mEq/liter)

Sodium (Na+)b 78
Potassium (K+) 66
Magnesium (Mg++) 10
Phosphorus mMc 30
Chloride (CI-) 86
Acetate (C2H3O2-) 61d
b Includes sodium from the pH adjustor.
c mM = millimoles; one mM of phosphorus = 31 mg P.
d Includes acetate from lysine acetate.

Electrolytes (mg/100 mL)

Sodium Chloridee 60 mg
Magnesium Chloride hexahydratef 102 mg
Sodium Phosphate, dibasicg 425 mg
Potassium Chlorideh 492 mg
e Sodium Chloride, USP is chemically designated NaCI, a white crystalline powder freely soluble in water.
f Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate, MgCl2•6H2O, deliquescent crystals very soluble in water.
g Sodium Phosphate, dibasic, USP is chemically designated Na2HPO4, white granules very soluble in water.
h Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.

The formulas for the individual amino acids present in Aminosyn II 8.5% (amino acid injection with electrolytes) WITH ELECTROLYTES are as follows:

Essential Amino Acids

Isoleucine, USP C6H13NO2
Leucine, USP C6H13NO2
Lysine Acetate, USP C6H14N2O2 • CH3COOH
Methionine, USP C5H11NO2S
Phenylalanine, USP C9H11NO2
Threonine, USP C4H9NO3
Tryptophan, USP C11H12N2O2
Valine, USP C5H11NO2

Nonessential Amino Acids

Alanine, USP C3H7NO2
Arginine, USP C6H14N4O2
L-Aspartic Acid C4H7NO4
HO2CCH2CH(NH2)CO2H
L-Glutamic Acid C5H9NO4
HO2CCH2CH2CH(NH2)CO2H
Glycine, USP C2H5NO2
Histidine, USP C6H9N3O2
Proline, USP C5H9NO2
Serine, USP C3H7NO3
N-Acetyl-L-Tyrosine C11H13NO4

N-Acetyl-L-Tyrosine  structural formula illustration

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 sufficient 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.

Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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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.


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