AMILAC ™
AMILAC 500 ML INFUSION | |
---|---|
Generic : | Amino Acid + D-Sorbitol + Electrolytes |
Thearapeutic : | Parenteral Nutrition |
Pack Size : | 500 ml |
Strength : | |
Dosage Form : | Infusion |
Amilac
5% W/V Composite Amino Acid + D-Sorbitol + Electrolytes
Description
Amilac is a sterile aqueous solution of crystalline amino acids and D-Sorbitol with electrolytes, which are necessary as nitrogen sources for parenteral nutrition. Nitrogen is provided in the form of essential and non-essential amino acids. The solution is clear, and colorless, having a pH lying in the range of 5.0 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
Amilac contains all 18 essential and non-essential amino acids needed for protein synthesis. The amino acid composition is such that a positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition.
Indications
Amilac is indicated as a source of amino acid for protein synthesis in patients needing intravenous nutrition. Aminos are particularly suitable for patients with basal amino acid requirements. Aminos are 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 of 0.10-0.25 g nitrogen/kg/day corresponds to 15-35 ml Amilac IV/kg/day.
In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients' requirements, 1000-2000 ml Amilac IV may be infused intravenously for 24 hours. Amilac IV should be infused slowly, at rates of 1.4-2.8 ml (30-60 drops) per minute.
Infants and Children:
In children and infants, the rate of infusion is 28-35 ml/kg body weight/day is recommended, with a step-wise increase in the rate of administration during the first week.
Adverse Effects:
Nausea occurs rarely. Transient increases in liver function tests during intravenous nutrition have been reported. The reasons are at present unclear. The underlying disease, the components, and their amounts in the intravenous feeding regimens have been suggested. Hypersensitivity reactions have been reported with amino acid solutions. As with all hypertonic infusion solutions, 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.
Contra-Indications
Amilac is contraindicated in patients with inborn errors of amino acid metabolism, irreversible liver damage, and severe uremia when dialysis facilities are not available.
Use in Pregnancy & lactation:
Successful and safe administration of amino acid solutions during pregnancy in humans has been reported. Animal reproduction studies have not been carried out with Amilac
Drug interaction:
At the recommended dosage the amino acid in amino solutions has no pharmacological effects and is not expected to interact with other medicaments.
Compatibility
Amilac should not be mixed with other preparations because of the increased risk of microbial contamination and incompatibility.
Precautions
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 it if the solution is turbid or contains particles. Discard any unused portion.
Pharmaceutical Precautions
- Protect from light and store between 15ºC to 25ºC temperature.
- Keep medications out of reach of children. Avoid freezing.
Commercial Pack:
Amilac is available in 500 ml glass bottles.
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