FREAMINE III- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, glycine, cysteine hydrochloride and phosphoric acid injection, solution
B. Braun Medical Inc.
Protect from light until use.
DESCRIPTION
10% FreAmine� III (Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. Each 1000 mL provides a total of 15.3 g of nitrogen in 97 g of amino acids equal to 95.6 grams of protein equivalent. All amino acids designated USP are the �L"-isomer, with the exception of Glycine USP, which does not have an isomer.
Each 100 mL contains:
Essential amino acids
Isoleucine USP �������������������� 0.69 g
Leucine USP ��������������������� 0.91 g
Lysine USP ���������������������.. 0.73 g
(added as Lysine Acetate USP �����������. 1.02 g)
Methionine USP �������������������. 0.53 g
Phenylalanine USP ������������������. 0.56 g
Threonine USP �������������������� 0.40 g
Tryptophan USP ������������������� 0.15 g
Valine USP ���������������������.. 0.66 g
Nonessential amino acids
Alanine USP ��������������������� 0.71 g
Arginine USP ��������������������.. 0.95 g
Histidine USP ��������������������. 0.28 g
Proline USP ��������������������� 1.12 g
Serine USP ���������������������.. 0.59 g
Glycine USP ��������������������� 1.40 g
Cysteine ����������������������.. <0.016 g
(as Cysteine HCl�H2 O USP �����������.. <0.024 g)
Phosphoric Acid NF����������������� 0.12 g
Sodium Bisulfite (as an antioxidant) ���������.. <0.10 g
Water for Injection USP ���������������. qs
pH adjusted with Glacial Acetic Acid USP
pH: 6.5 (6.0 � 7.0)
Calculated Osmolarity: 950 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 10
Phosphate (HPOfigure) 20 (10 mmole P/liter); Acetate Approx. 89(provided as acetic acid and lysine acetate); Chloride <3.
CLINICAL PHARMACOLOGY
10% FreAmine� III provides a physiological ratio of biologically utilizable amino acids in concentrated form for protein synthesis. Used with concentrated calorie sources such as hypertonic dextrose or fat emulsion, and with electrolytes, vitamins and minerals, it provides total parenteral nutrition. Administered peripherally as an isotonic solution (3%) without nonprotein calories or with minimal caloric supplementation such as 5% dextrose, it provides nutritional support and spares body protein.
Phosphate is a major intracellular anion which participates in providing energy for metabolism of substrates and contributes to significant metabolic and enzymatic reactions in all organs and tissues. It exerts a modifying influence on calcium levels, a buffering effect on acid-base equilibrium and has a primary role in the renal excretion of hydrogen ions.
It is thought that the acetate from lysine acetate and acetic acid, under the condition of parenteral nutrition, does not impact net acid-base balance when renal and respiratory functions are normal. Clinical evidence seems to support this thinking; however, confirmatory experimental evidence is not available.
The amounts of sodium and chloride present are not of clinical significance.
INDICATIONS AND USAGE
Parenteral nutrition with 10% FreAmine� III (Amino Acid Injection) is indicated to prevent nitrogen loss or treat negative nitrogen balance in adults and pediatric patients where (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of nonprotein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. See WARNINGS, PRECAUTIONS, Pediatric Use, and DOSAGE AND ADMINISTRATION.
