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Aminosyn HBC 7% Sulfite Free

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Aminosyn HBC 7% Sulfite Free

AMINOSYN®-HBC 7% (amino acid injection high branched chain)
Sulfite-Free

AN AMINO ACID INJECTION – HIGH BRANCHED CHAIN
Flexible Plastic Container

DRUG DESCRIPTION

Aminosyn®-HBC 7%, Sulfite-Free, (an amino acid injection high branched chain) is a sterile, nonpyrogenic, hypertonic solution for intravenous infusion. Aminosyn-HBC 7% is oxygen sensitive. The solution contains the following crystalline amino acids:

Essential Amino Acids (mg/100 mL)
  Isoleucine 789
  Leucine 1576
  Lysine (acetate)* 265
  Methionine 206
  Phenylalanine 228
  Threonine 272
  Tryptophan 88
  Valine 789
Nonessential Amino Acids (mg/100 mL)
  Alanine 660
  Arginine 507
  Histidine** 154
  Proline 448
  Serine 221
  Tyrosine 33
  Glycine 660
*Amount cited is for lysine alone and does not include the acetate salt.
**Histidine is considered essential for patients in renal failure.

Crystalline Amino Acids (g/100 mL) 7
Branched Chain Amino Acids (g/100 mL) 3.2
Nitrogen (approx. g/100 mL) 1.12
Acetate (C2H3O2-)a (mEq/Liter) 71a
Osmolarity (mOsmol/liter) 623
pHb (Range) 5.2 (4.5 to 6.0)
a Includes acetate from acetic acid used in processing and from lysine acetate.
b May contain hydrochloric acid for pH adjustment.

The formulas for the individual amino acids present in Aminosyn-HBC 7% 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
  Histidine, USP C6H9N3O2
  Proline, USP C5H9NO2
  Serine, USP C3H7NO3
  Tyrosine, USP C9H11NO3
  Glycine, USP C2H5NO2

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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