Product Dossier

IOSCAN

Product Dossier for IOSCAN (sodium amidotrizoate, Iotech). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

IOSCAN is a contrast medium for Computerised Axial Tomography examination of the gastrointestinal tract. IOSCAN is a clear, yellow, light syrupy liquid containing sodium amidotrizoate as active ingredient, with a concentration of 1.853 %w/v in the diluted solution. It should be made up with water prior to use and administered orally. It is indicated primarily for use when barium sulphate is not appropriate.

Approved indications

— Contrast medium for Computerised Axial Tomography examination of the gastrointestinal tract.

Dosing overview

The dose is 200 ml of diluted solution, diluted as per instructions, at one and a half hour, one hour, and half hour before examination, or as instructed by the radiologist. For the 10 ml sachet, open IOSCAN and pour into a 250 mL cup, fill with water to the 200 mL mark, mix with a spoon and drink. For the 100 ml bottle, measure each 10 ml and dilute to 200 ml with drinking water and mix. Do not store the diluted solution.

Key safety warnings

IOSCAN must not be used intravascularly. Accidental aspiration of concentrated solutions of sodium amidotrizoate has been reported as causing fatal pulmonary oedema, presumably due to the hypertonicity of the solution. Use with caution in patients with asthma or a history of allergy, and in patients with hyperthyroidism because of the iodine content. IOSCAN solutions are hypertonic and may cause movement of fluid to the intestinal lumen; IOSCAN should be used with caution in dehydrated and debilitated patients and patients with marked electrolyte disturbances. Hypertonic solutions of sodium amidotrizoate have been reported to cause hypovolaemia in infants and young children, on occasions resulting in a shock-like state; however, IOSCAN when made up according to instructions is not hypertonic, but should be used with caution in infants and young children. Thyroid function in infants exposed to iodinated contrast media should be evaluated and monitored, as decreased levels of thyroxine (T4) and triiodothyronine (T3) and increased level of thyroid stimulating hormone (TSH) have been reported after exposure, especially in preterm infants, which remained for up to a few weeks or more than a month.

Contraindications

History of anaphylaxis or other severe allergic reaction to iodine or iodine-containing contrast media.

Regulatory history

IOSCAN sodium amidotrizoate 3.705 g/10 mL oral liquid sachet (ARTG 65970) was first listed on 21 September 1998. IOSCAN sodium amidotrizoate 370.5 mg/mL oral solution bottle (ARTG 80666) was first listed on 10 December 2001.