FreAmine HBC

FREAMINE HBC- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, glycine and cysteine hydrochloride injection, solution
B. Braun Medical Inc.

Protect from light until use.

DESCRIPTION

6.9% FreAmine HBC® (Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. A 750 mL partial fill unit provides a total of 7.3 g of nitrogen in 50 g of amino acids equal to 46 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 …………………………………………………… 0.76 g

Leucine USP ……………………………………………………… 1.37 g

Lysine ………………………………………………………………. 0.41 g

(added as Lysine Acetate USP ……………………………. 0.58 g)

Methionine USP …………………………………………………. 0.25 g

Phenylalanine USP ………………………………………………. 0.32 g

Threonine USP …………………………………………………… 0.20 g

Tryptophan USP ………………………………………………… 0.09 g

Valine USP ……………………………………………………….. 0.88 g

Nonessential Amino Acids

Alanine USP ……………………………………………………… 0.40 g

Arginine USP …………………………………………………….. 0.58 g

Histidine USP ……………………………………………………. 0.16 g

Proline USP ……………………………………………………… 0.63 g

Serine USP ……………………………………………………….. 0.33 g

Glycine USP ……………………………………………………… 0.33 g

Cysteine ………………………………………………………….. <0.014 g

(as Cysteine HCl•H2 O USP …………………………….. <0.020 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: 620 mOsmol/liter

Concentration of Electrolytes (mEq/liter): Sodium 10; Chloride <3 Acetate Approx. 59.3 (provided as acetic acid and lysine acetate)

CLINICAL PHARMACOLOGY

6.9% FreAmine HBC® solution provides a mixture of biologically utilizable essential and nonessential crystalline amino acids in concentrated form for protein synthesis. 6.9% FreAmine HBC® contains a high concentration of the branched chain amino acids isoleucine, leucine, and valine relative to other general purpose amino acid injections. This amino acid solution, appropriately mixed with a concentrated calorie source such as hypertonic dextrose, with or without fat emulsion, and supplemented with electrolytes, vitamins, and minerals, provides total parenteral nutrition for the severely compromised patient. 6.9% FreAmine HBC® solution may also be administered peripherally with minimal caloric supplementation in order to conserve lean body mass in the well-nourished, mildly catabolic patient.

The concentration of branched chain amino acids in 6.9% FreAmine HBC® has been increased because these amino acids have been reported to be especially active metabolically in the compromised patient.

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 6.9% FreAmine HBC® (Amino Acid Injection) is indicated to prevent nitrogen loss or treat negative nitrogen balance in adults 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) nitrogen homeostasis is substantially impaired as with severe trauma or sepsis. Dosage, route of administration, and concomitant infusion of non-protein 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 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 with minimal caloric supplementation 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).

CONTRAINDICATIONS

6.9% FreAmine HBC® is contraindicated in patients with anuria, hepatic coma, inborn errors of amino acid metabolism, especially those involving branched chain amino acid metabolism such as Maple Syrup Urine Disease and Isovaleric Acidemia, or hypersensitivity to one or more amino acids present in the solution.

WARNINGS

This product contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Safe and effective use of central venous nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring of central venous nutrition. Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base balance and fluid balance. Other laboratory tests may be suggested by the patient’s condition.

The intravenous administration of these solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the solute concentration of the solution infused. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the concentration of the solution.

Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.

Administration of amino acid solutions that have not been specifically formulated to treat patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.

Conservative doses of amino acids should be given, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient’s clinical status reevaluated.

PRECAUTIONS

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