HEPATAMINE- 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
HepatAmine� (8% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. A 500 mL unit provides a total of 40 g of amino acids and 6 g of nitrogen (38 g of protein equivalent).
Each 100 mL contains:
Essential Amino Acids
Isoleucine USP���������������.0.90 g
Leucine USP����������������.1.10 g
Lysine�������������������..0.61 g
(added as Lysine Acetate USP������..0.86 g)
Methionine USP��������������..0.10 g
Phenylalanine USP�������������..0.10 g
Threonine USP���������������.0.45 g
Tryptophan USP�������������..0.066 g
Valine USP�����������������0.84 g
Nonessential Amino Acids
Alanine USP����������������..0.77 g
Arginine USP����������������.0.60 g
Histidine USP����������������.0.24 g
Proline USP�����������������0.80 g
Serine USP�����������������.0.50 g
Glycine USP����������������..0.90 g
Cysteine�����������������.<0.014 g
(as Cysteine HCl�H2 O USP������..<0.020 g)
Phosphoric Acid NF������������0.115 g
Sodium Bisulfite (as an antioxidant)�����.<0.1 g
Water for Injection USP������������..qs
pH adjusted with Glacial Acetic Acid USP
pH: 6.5 (6.0�6.8)
Calculated Osmolarity: 785 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 10; Chloride <3
Phosphate (HPO=4 symbol) 20 (10 mmole P/liter); Acetate Approx. 62 (provided as acetic acid and Iysine acetate)
CLINICAL PHARMACOLOGY
HepatAmine� provides a mixture of essential and nonessential amino acids with high concentrations of the branched chain amino acids isoleucine, leucine, and valine, and low concentrations of methionine and the aromatic amino acids phenylalanine and tryptophan, relative to general purpose amino acid injections. This amino acid composition has been specifically formulated to provide a well tolerated nitrogen source for nutritional support and therapy of patients with liver disease who have hepatic encephalopathy.
The precise mechanisms which produce the therapeutic effects of HepatAmine� are not known. The etiopathology of hepatic encephalopathy is also unknown and is thought to be of multifactorial origin. The rationale for HepatAmine� is based on observations of plasma amino acid imbalances in patients with liver disease and on theories which postulate that these abnormal patterns are causally related to the development of hepatic encephalopathy.
Clinical studies in patients with hepatic encephalopathy showed that infusion of HepatAmine� reversed the abnormal plasma amino acid pattern characterized by decreased levels of branched chain amino acids and elevated levels of aromatic amino acids and methionine. The trend toward normalization of these amino acids was generally associated with an improvement in mental status and EEG patterns. This clinical response was observed in the majority of patients studied. Nitrogen balance was significantly improved and mortality reduced in these typically protein-intolerant patients who received substantial amounts of protein equivalent as HepatAmine� (8% Amino Acid Injection).
When infused with hypertonic dextrose as a calorie source, supplemented with electrolytes, vitamins, and minerals, HepatAmine� provides total parenteral nutrition in patients with liver disease, with the exception of essential fatty acids.
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 conditions 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
HepatAmine� is indicated for the treatment of hepatic encephalopathy in patients with cirrhosis or hepatitis. HepatAmine� provides nutritional support for patients with these diseases of the liver who require parenteral nutrition and are intolerant of general purpose amino acid injections, which are contraindicated in patients with hepatic coma.
