An 8% Amino Acid Injection which 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•H2O 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) 20 (10 mmole P/liter); Acetate Approx. 62 (provided as acetic acid and Iysine acetate)
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, compared to general purpose amino acid infusions.
Provides a well tolerated nitrogen source for nutritional support and therapy of patients with liver disease with hepatic encephalopathy.
Mnagement of patients with liver disease is to provide nutrition with sufficient amino acid and caloric support for protein synthesis without exacerbating hepatic encephalopathy.
Infusion reverses the abnormal plasma amino acid pattern characterized by decreased levels of branched chain amino acids and elevated levels of aromatic amino acids and methionine present in hepatic encephalopathy.
Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.
When utilized with hypertonic dextrose, electrolytes, vitamins, and minerals provides total parenteral nutrition in patients with liver disease, with the exception of essential fatty acids.
Indicated for the treatment of hepatic encephalopathy in patients with cirrhosis or hepatitis.
Use contraindicated in patients with anuria, 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 amino acids present in the solution.
Contains sodium bisulfite, that may cause allergic-type reactions in susceptible individuals.
Contains aluminum that may reach toxic levels with prolonged parenteral administration if kidney function is impaired, and premature neonates are particularly at risk because their kidneys are immature.
HepatAmine contains less than 3 mEq chloride per liter, and 10 mmole/liter of phosphate, contains no more than 25 µg/L of aluminum.
Substantially excreted by the kidney.
The recommended dosage is 80–120 grams of amino acids (12–18 grams of nitrogen per day.
Typically, 500 mL mixed with 500 mL of 50% dextrose supplemented with electrolytes and vitamins is administered over an 8–12 hour period.
Fat emulsion therapy should be utilized with Hepatamine when prolonged parenteral nutrition is required to prevent essential fatty acid deficiency.
Intracellular electrolytes, principally potassium (60-180 mEq/d), magnesium (10-30mEq/d), and phosphate (10-40mmol/d), are required for optimum utilization of amino acids.
Sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must also be given.
Recommended infusion rates are 60–125 mL/hr.
May be administered by peripheral vein with or without parenteral carbohydrate calories prepared by dilution of 8% HepatAmine with Sterile Water for Injection or 5%–10% dextrose to prepare isotonic or slightly hypertonic solutions for peripheral infusion.