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Amisol IV Infusion
Amino Acid, D-sorbitol & Electrolytes
Amisol  IV Infusion

Each 100ml contains

Active ingredients

Specification

Quantity

 

Essential Amino Acids

 

 

 

L-Isoleucine

USP

0.352

g

L-Leucine

USP

0.49

g

L-Lysine Hydrochloride

USP

0.43

g

L-Methionine

USP

0.225

g

L-Phenylalanine

USP

0.533

g

L-Threonine

USP

0.25

g

L-Tryptophan

USP

0.09

g

L-Valine

USP

0.36

g

L-Histidine

USP

0.25

g

L-Tyrosine

USP

0.025

g

Non-Essential Amino Acids

 

 

 

L-Arginine

USP

0.50

g

L-Aspartic Acid

USP

0.25

g

L-Glutamic Acid

BP

0.075

g

L-Alanine

USP

0.20

g

L-Cystine

BP

0.01

g

Glycine (Aminoacetic Acid)

USP

0.76

g

L-Proline

USP

0.10

g

L-Serine

USP

0.10

g

Carbohydrate

 

 

 

D-Sorbitol

BP

5.00

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.

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Pharmacology/Description

AmisolTM 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 5.0 to 7.0.

Indications

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

Dosage And 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 0.10-0.15g 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 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.

Side 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.

Drug Interactions

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

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.


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 AmisolTM.

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 250 ml & 500 ml glass bottle.