Description

Amisol ^(TM) 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 5.7 to 7.0.

Composition
Each 100 ml contains

Active ingredients Specification Quantity
Essential Amino Acids
L-Isoleucine USP 0.352 g
L-Leucine USP 0.490 g
L-Lysine Hydrochloride USP 0.430 g
L-Methionine USP 0.225 g
L-Phenylalanine USP 0.533 g
L-Threonine USP 0.250 g
L-Tryptophan USP 0.090 g
L-Valine USP 0.360 g
L-Histidine USP 0.250 g
L-Tyrosine USP 0.025 g
Non-Essential Amino Acids
L-Arginine USP 0.500 g
L-Aspartic Acid USP 0.250 g
L-Glutamic Acid BP 0.075 g
L-Alanine USP 0.200 g
L-Cystine BP 0.010 g
Glycine (Aminoacetic Acid) USP 0.760 g
L-Proline USP 0.100 g
L-Serine USP 0.100 g

Carbohydrate
D-Sorbitol BP 5.000 g

Electrolytes (mmol/L)
Sodium (Na+) 35.5
Potassium (K+) 25.0
Magnesium (Mg++) 2.5
Chloride (Cl-) 53.4
Acetate (CH3COO-) 25.0

Clinical Pharmacology
AmisolTM 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.

Indications
AmisolTM is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amisol is particularly suitable for patients with basal amino acid requirements. Amisol is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Dosage
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 0.10-0.15g nitrogen/kg/day (no or minor metabolic stress and normal nutritional state), 0.15-0.20g nitrogen/kg/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma). The dosage range 0.10-0.25g nitrogen/kg/day corresponds to 15-35 ml AmisolTM/kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml AmisolTM may be infused intravenously per 24 hours. AmisolTM should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and children:
In children and infants, the rate of infusion 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.

Adverse Effects
AmisolTM is usually well tolerated. Nausea Occurs rarely. Vomiting, flushing and sweating have been observed during infusion of AmisolTM 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.

Contraindications
AmisolTM is contraindicated in patients with inborn errors of amino acids metabolism, irreversible liver damage and severe uremia when dialysis facilities are not available.

Use in Pregnancy
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 Amisol.

Drug Interactions
At the recommended dosage the amino acid in Amisol solutions have no pharmacological effects and is not expected to interact with other medicaments.

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

Precautions
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.

Pharmaceutical Precautions
Protect from light and store between 15oC to 25oC temperature. Avoid freezing. Keep out of the reach of children.

Commercial Pack
AmisolTM is available in 500 ml glass bottle.