Recommended Topic Related To:

Aminosyn HF 8

"As required by the bipartisan FDA Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today proposed a rule that would require the largest food businesses in the United States and abroad to take steps to prevent facilities"...

Aminosyn HF 8%

AMINOSYN®-HF 8%
(amino acid) Injection

Flexible Plastic Container
Avoid exposure to light until use
Hepatic Formula

DRUG DESCRIPTION

Aminosyn-HF 8% (amino acid injection 8%) is a sterile, nonpyrogenic, hypertonic solution for intravenous infusion. The formulation is described below:

Aminosyn-HF 8% An Amino Acid Injection–Hepatic Formula Essential Amino Acids (mg/100 mL)

Isoleucine 900
Leucine 1,100
Lysine (acetate)* 610
Methionine 100
Phenylalanine 100
Threonine 450
Tryptophan 66
Valine 840
*Amount cited is for lysine alone and does not include the acetate salt.

Nonessential Amino Acids (mg/100 mL)

Alanine 770
Arginine 600
Cysteine HCl • H20 < 20
Glycine 900
Histidine 240
Proline 800
Serine 500

Electrolytes (mEq/Liter)

Sodium (Na+) 11
Phosphate (HPO=4) 20a
Acetate (C2H3O2-)b approx. 62c
Chloride (Cl-) < 3
a 10 mmoles P/L
b Including ions for pH adjustment
c From lysine acetate

Product Characteristics per 100 mL

Nitrogen 1.2gd
Sodium Hydrosulfite 100mge
Phosphoric Acid 115mg
pH 6.4
pH Range 6.0 to 7.0f
Osmolarity 768 mOsmol/Liter
Specific Gravity 1.02
d 7.6g of protein equivalent
e Added as the antioxidant
f Adjusted with glacial acetic acid

The formulas for the individual amino acids present in Aminosyn–HF 8% 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 IllustrationCH2CH(NH2)COOH
Threonine CH3CH(OH)CH(NH2)COOH
Tryptophan Tryptophan Structural Formula IllustrationCH2CH(NH2)COOH
Valine (CH3)2CHCH(NH2)COOH

Nonessential Amino Acids

Alanine CH3CH(NH2)COOH
Arginine H2NC(NH)NH(CH2)3CH(NH2)COOH
Cysteine HCl • H20 HSCH2CH(NH2)COOH • HCl • H20
Glycine H2NCH2COOH
Histidine Histidine Structural Formula IllustrationCH2CH(NH2)COOH
Proline Proline Structural Formula Illustration
Serine HOCH2CH(NH2)COOH

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 can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthlate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

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.

A A A

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.


NIH talks about Ebola on WebMD

From WebMD