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[ Solution of 5% Composite Amino Acid with Electrolytes & D-Sorbitol ]
IV Infusion
Composition
Aminobost IV: Each 100 ml contains L-Isoleucine USP 0.352 gm, L-Leucine USP 0.490 gm, L-Lysine Hydrochloride USP 0.430 gm, L-Methionine USP 0.225 gm, L-Phenylalanine USP 0.533 gm, L-Threonine USP 0.250 gm, L-Tryptophan USP 0.090 gm, L-Valine USP 0.360 gm, L-Histidine USP 0.250 gm, L-Tyrosine USP 0.025 gm, L-Arginine USP 0.500 gm, L-Aspartic Acid USP 0.250 gm, L- lutamic Acid BP 0.075 gm, L-Alanine USP 0.200 gm, L-Cystine BP 0.010 gm, Glycine (Aminoacetic Acid) USP 0.760 gm, L-Proline USP 0.100 gm, L-Serine USP 0.100 gm, D-Sorbitol BP 5.00 gm, Sodium(Na+) 35.5 mmol/L, Potassium(K+) 25.0 mmol/L, Magnesium(Mg++) 2.5 mmol/L, Chloride(Cl-) 53.4 mmol/L, Acetate (CH3COO-) 25.0 mmol/L.
Pharmacology
This is a sterile aqueous solution of crystalline Amino Acids and D-Sorbitol with electrolytes, which are necessary as the nitrogen, sources for parenteral nutrition. Nitrogen is provided in the form of essential and non-essential amino acids. The solution is clear, colorless, having a pH lying in the range of 6.0 to 7.0.
Indication
Amino Acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. This is particularly suitable for patients with basal amino acid requirements. Amino acid is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.
Dosage & administration
Adults: The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress). The requirements are 0.10-0.15 g nitrogen/kg/day (no or minor metabolic stress and normal nutritional state), 0.15-0.20 g nitrogen/kg/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25 g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma). The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml IV/kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon patient's requirements, 1000-2000 ml IV may be infused intravenously per 24 hours. It should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute. Pediatric use: In children and infants, the rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step wise increase in the rate of administration during the first week.
Contra-indication
Contraindicated in patients with inborn errors of amino acids metabolism, irreversible liver damage and severe uremia when dialysis facilities are not available.
Warning & precaution
Hyperphenylalaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine levels is recommended and the infusion rate is adjusted as needed. Do not use if the solution is turbid or contains particles. Discard any unused portion.
Side effects
Nausea Occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rare. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. The underlying disease and the components and their amount in the intravenous feeding regimens have been suggested. Hypersensitivity reactions have been reported. As with all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The Incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.
Use in pregnancy & lactation
Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amino acid.
Use in special population
In patients with impaired renal function should be administered with caution. In patients with impaired liver function should be administered starting at the low end of the dosing range. Frequent clinical evaluation and laboratory tests to monitor liver function such as bilirubin and liver function parameters should be conducted.
Drug interaction
At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.
Overdose
An increased infusion rate can cause hypervolemia, electrolyte disturbances, acidosis and/or azotemia, hyperglycemia, hyperosmolality.
Storage
Protect from light and store at below 25°C temperature. Avoid freezing. Keep out of the reach of children.
Packing
Aminobost IV: Each box contains sterile solution of 5% composite Amino Acid with electrolytes & D-Sorbitol for infusion in a glass bottle with infusion set and plastic hanger.
