FreAmine III

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•H2O 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 (HPO) 20 (10 mmole P/liter); Acetate Approx. 89
(provided as acetic acid and lysine acetate); Chloride <3.

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.

Central Venous Nutrition

Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted patients, or those requiring long-term parenteral nutrition.

Peripheral Parenteral Nutrition

For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Protein Sparing

In well-nourished, mildly catabolic patients such as routine postsurgical patients who require only short-term parenteral nutrition, protein sparing can be achieved by peripheral infusion of amino acid solutions with or without dextrose.

See "WARNINGS" and "Special Precautions for Central Venous Nutrition."

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

Local reactions of the infusion site, consisting of a warm sensation, erythema, phlebitis and thrombosis, have been reported with peripheral amino acid infusions, especially if other substances are also administered through the same site.

Generalized flushing, fever and nausea have been reported during peripheral administration of amino acids.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

If electrolyte supplementation is required during peripheral infusion, it is recommended that additives be administered throughout the day in order to avoid possible venous irritation. Irritating additive medications may require injection at another site and should not be added directly to the amino acid infusate.

Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

For severely catabolic, depleted patients or those requiring long-term total parenteral nutrition, central venous nutrition should be considered. Calorie-to-nitrogen ratios of at least 100 to 150 nonprotein calories per gram of nitrogen have been recommended to achieve positive nitrogen balance in such patients. These ratios are easily and conveniently attained with the use of concentrated dextrose solutions, supplemented if desired with parenteral fat emulsion.

Total parenteral nutrition may be started with infusates containing lower concentrations of dextrose; dextrose content may be gradually increased to estimated caloric needs as the patient's glucose tolerance increases.

In adults, strongly hypertonic mixtures of amino acids and dextrose may be safely administered only by continuous infusion through a central venous catheter with the tip located in the vena cava. For optimal nitrogen utilization, 500 mL of 10% FreAmine® III appropriately mixed with concentrated dextrose, electrolytes, and vitamins are typically administered over an 8-hour period. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made. In addition to meeting protein needs, the administration rate is also governed, especially during the first few days of therapy by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determination of urine and blood sugar levels. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued.

Use of 10% FreAmine® III in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).

Infants (up to 10 kg) on total parenteral nutrition generally receive 2 to 3 grams of protein, 120 to 150 calories, and 120 to 150 mL of fluid per kilogram of body weight per day. This can be provided in a solution containing approximately 2-1/8% FreAmine® III (diluted from 10% FreAmine® III (Amino Acid Injection) and 20% dextrose. Less hypertonic mixtures may be administered by peripheral vein. Fat emulsion may be given concurrently by central or peripheral vein through a Y-type administration set to provide essential fatty acids and increase caloric intake. Since physiological changes occur rapidly in small infants, the daily dose of nutrients should initially be increased slowly with frequent monitoring of pertinent clinical and metabolic parameters. Pediatric patients over 10 kilograms require fewer calories and slightly less protein; generally 50 to 80 calories and 2 grams of protein per kilogram per day is sufficient.

See INDICATIONS AND USAGE, WARNINGS, and PRECAUTIONS, Pediatric Use.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Care must be taken to avoid incompatible admixtures. Consult with pharmacist.

1000 mL

NDC 0264-9010-55
S9010-SS

10% FreAmine® III
(Amino Acid Injection)

Protect from light until use.

Each 100 mL contains:
Essential amino acids Isoleucine USP 0.69 g
Leucine USP 0.91 g; Lysine 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•H2O USP <0.024 g)

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA

Phosphoric Acid NF 0.12 g
Sodium Bisulfite (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

Electrolytes (mEq/liter): Sodium 10
Phosphate (HPO ) 20 (10 mmole P/liter)
Acetate 89 (see Package Insert) Chloride <3

Sterile, nonpyrogenic. Single dose container.

For intravenous use only. Use only if solution
is clear and vacuum is present.

Recommended Storage:
Room temperature (25°C). Avoid excessive heat. Protect from freezing.
See Package Insert.

Rx only

FreAmine is a registered trademark of B. Braun Medical Inc.

Made in USA
Y37-002-270   LD-357-1