Aminosyn®-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-RF 5.2% is oxygen sensitive. The solution contains the following crystalline amino acids: mg/100 mL Min. Daily
Need (mg**) Essential Amino Acids Isoleucine 462 700 Leucine 726 1100 Lysine Acetate* 535 800 Methionine 726 1100 Phenylalanine 726 1100 Threonine 330 500 Tryptophan 165 250 Valine 528 800 Nonessential Amino Acids Arginine 600 __ Histidine*** 429 __ * Amount cited is for Lysine alone and does not include the acetate salt.
** The minimum daily quantities needed to maintain nitrogen balance in the healthy adult. (Rose, W.C., The Sequence of Events Leading to the Establishment of the Amino Acid Needs of Man, Am J. Public Health, 58:2020, 1968.)
*** Histidine is considered essential for patients in renal failure. Electrolytes and Product Characteristics
Acetate (C2H3O2_)a (mEq/Liter) 113 Protein Equivalent (approx. grams/liter) 52.27 Total Nitrogen (grams/liter) 7.93 Osmolarity (mOsmol/liter) 427 pH (Range) 5.2 (4.5 to 6.0b) a Includes acetate from acetic acid used in processing and from Lysine acetate.
b Adjusted with acetic acid. Each 500 mL represents three Rose Units of essential amino acids plus arginine and histidine. The formulas for the individual amino acids present in Aminosyn-RF 5.2% 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 Arginine, USP (C6H14N4O2) Histidine, USP (C6H9N3O2) 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.