Composition
Each 100 ml contains (5% IV Infusion):
Essential Amino Acids Specification Quantity-
L-Isoleucine 0.352 gm
L-Leucine 0.490 gm
L-Lysine Hydrochloride 0.430 gm
L-Methionine 0.225 gm
L-Phenylalanine 0.533 gm
L-Threonine 0.250 gm
L-Tryptophan 0.090 gm
L-Valine 0.360 gm
L-Histidine 0.250 gm
L-Tyrosine 0.025 gm
Non Essential Amino Acids-
L-Arginine 0.500 gm
L-Aspartic Acid 0.250 gm
L-Glutamic Acid 0.075 gm
L-Alanine 0.200 gm
L-Cystine 0.010 gm
Glycine (Aminoacetic Acid) 0.760 gm
L-Proline 0.100 gm
L-Serine 0.100 gm
Carbohydrate Specification Quantity-
D-Sorbitol 5.00 gm
Electrolytes Quantity
Sodium(Na+) 40.78 mmol/L
Potassium(K+) 25 mmol/L
Magnesium(Mg++) 2.5 mmol/L
Chloride(Cl-) 53.54 mmol/L
Acetate(CH3COO-) 25 mmol/L
Nitrogen content: 7.7 gm/L
Each 100 ml contains (10% IV Infusion):
Essential Amino Acids-
L-Isoleucine 0.390 g
L-Leucine 0.530 g
L-Lysine Hydrochloride 0.390 g
L-Methionine 0.190 g
L-Phenylalanine 0.550 g
L-Threonine 0.300 g
L-Tryptophan 0.100 g
L-Valine 0.430 g
L-Histidine 0.240 g
L-Tyrosine 0.050 g
Non-Essential Amino Acids-
L-Arginine 0.330 g
L-Aspartic Acid 0.410 g
L-Glutamic Acid 0.900 g
L-Alanine 0.300 g
L-Cystine 0.140 g
Glycine (Aminoacetic Acid) 0.210 g
L-Proline 0.810 g
L-Serine 0.750 g
Carbohydrate Anhydrous Glucose 10.00 g
Electrolytes (mmol/L)-
Sodium (Na+) 50.0
Potassium (K+) 20.0
Calcium (Ca++) 2.5
Magnesium (Mg++) 1.5
Chloride (Cl-) 32.0
Indications
Amino acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amino acid 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.
Therapeutic Class
Parenteral Nutritional preparations
Description
This contains all 18 essential and non-essential amino acid needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition.
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.
Pharmacology
Amino acids is a sterile aqueous solution of Amino Acids IV Infusion and 10% Glucose 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.
Pharmacodynamics: Amino Acid IV Infusion with 10% Glucose and Electrolytes contains amino acids and electrolytes, which are all present in ordinary food. Apart from the nutritive properties Amino Acid IV Infusion with 10% Glucose and Electrolytes should have no specific pharmacodynamic effects. To optimize the utilization of supplied amino acids, adequate energy should be supplied in the form of carbohydrates (preferably glucose) and fat.
Pharmacokinetics: The principle pharmacokinetic properties for Amino Acid IV Infusion with 10% Glucose and Electrolytes are essentially the same as for amino acids supplied by ordinary food. However, the amino acids of dietary protein first enter the portal vein and then the systemic circulation, while intravenously infused amino acids reach the systemic circulation directly.
Preclinical safety studies with Amino Acid IV Infusion with 10% Glucose and Electrolytes demonstrated good tolerance.
Dosage & Administration
The nitrogen requirement for maintenance of body protein mass depends on the patient’s condition (nutritional state and degree of metabolic stress).
No or minor metabolic stress and normal nutritional state: 0.10-0.15 g nitrogen/kg/day,
Moderate metabolic stress with or without malnutrition: 0.15-0.20 g nitrogen/kg/day,
Severe catabolism as in burns, sepsis and trauma: up to 0.20-0.25 g nitrogen/kg/day.
The dosage range 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amino acids IV/kg/day.
In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amino acids IV may be infused intravenously per 24 hours. Amino acids IV should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.
Contraindications
Amino acid is contraindicated in patients with inborn errors of amino acids metabolism, irreversible liver damage and severe uremia when dialysis facilities are not available.
Side Effects
Amino acid is usually well tolerated. 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.
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