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Composition

Each 100 ml solution (5%) contains:

Essential Amino Acids-
  • 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
Excipients
  • D-Sorbitol 5.000 gm
Electrolytes
  • Sodium (Na+) 57 mmol/L
  • Potassium (K+) 25 mmol/L
  • Magnesium (Mg++) 1.2 mmol/L
  • Chloride (Cl-) 87 mmol/L
  • Acetate (CH3COO-) 25 mmol/L
Total Nitrogen Content: 7.25 gm/L
Total Energy Content: 1551 kj/L (371.14 Kcal/L)

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

This IV solution is a sterile aqueous solution of crystalline Amino Acid and D-Sorbitol with electrolytes, which are necessary as the nitrogen source for parenteral nutrition. Nitrogen provided in the form of essential and non-essential amino acids. This IV solution contains all 18 essential and non-essential amino acids 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. The solution is clear, colorless to pale yellow colored, having a p H lying in the range of 5.0 to 7.0.

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.

Interaction

At the recommended dosage the amino acid have no pharmacological efects and is not expected to interact with other medicaments.

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.

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. amino acids should not be mixed with other preparations because of the increased risk of microbial contamination and incompatibility.

Precautions & Warnings

Hyperphenylaninemia 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.

Use in Special Populations

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.

Storage Conditions

Protect from light and store between 15°C to 25°C temperature. Avoid freezing. Keep out of the reach of children.