Consumer medicine information

Ioscan (sachet)

CMI for Ioscan Sachets

Sodium amidotrizoate

BRAND INFORMATION

Brand name

Ioscan

Active ingredient

Sodium amidotrizoate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ioscan (sachet).

What is in IOSCAN?

IOSCAN is a product which has sodium amidotrizoate as the active ingredient.

Plus

  • sorbitol
  • acesulfame potassium
  • methylhydroxybenzoate
  • citric acid-anhydrous
  • quinoline yellow colour
  • lemon flavouring
  • water

in 10 mL sachets which are diluted with water prior to use.

What is it used for and how does it work?

IOSCAN is an oral solution for CAT-SCAN examination of the gastrointestinal tract. It must be diluted with water according to the directions prior to ingestion. It may be used when barium sulphate is not suitable.

Your doctor will have explained why you are being treated with IOSCAN and told you what dose to take.

What do I do before taking IOSCAN?

Let your doctor know if you have used IOSCAN before and if you had any problems with it.

Tell your doctor if you are pregnant, if you are planning to become pregnant or are breastfeeding

Tell your doctor if you have ever sufferd from asthma or a history of allergy

Let your doctor know if you have any known allegic reaction to contrast media or iodine, or you are being treated for thyroid disease.

Tell your doctor if you are dehydrated or if you have any problem with the amount of salt in your body.

How do I take IOSCAN properly?

IOSCAN must be diluted with water according to instructions prior to drinking. The doctor will tell you when and how much you need to drink.

Instruction

Open the IOSCAN sachet and pour into a cup, graduated to indicate a volume of 200 ml, and fill with water to the 200 ml mark, stir briefly with a spoon and drink. Do not store the diluted solution.

Usual dose

1 Sachet, diluted as in the instruction, at one and a half hour, one hour, and half hour before examination, or as instructed by the radiologist.

What if I have any problems taking IOSCAN?

The most common adverse effect seen with IOSCAN is a mild diarrhoea but this ceases as soon as the intestinal has been emptied.

Like all medicines there is risk that IOSCAN may cause new problems, however, the benefits that normally result from taking IOSCAN are generally considered great enough to be worth taking that small risk.

What if I take too much IOSCAN?

As your doctor will tell you how much to take, it is unlikely that you can take too much IOSCAN.

If you think you or anyone else may have taken too much IOSCAN immediately telephone your doctor or the Poisons Information Centre (13 11 26).for advise

If you take too much IOSCAN you may get mild diarrhoea.

Where should IOSCAN be stored?

IOSCAN should be kept in the sachet and stored below 30°C until the time of use. Sachets which have passed the use-by (expiry) date marked on the pack should be disposed of safely or returned to the pharmacist.

Do not use if sachet is torn or damaged.

Who do I ask if I have any questions about IOSCAN?

This leaflet does not tell you all that is known about IOSCAN. Please take any questions or problems that you may have about IOSCAN to your doctor or pharmacist. They will be happy to discuss them with you.

Who distributes IOSCAN

REGIONAL IMAGING
3 - 11 Primrose Avenue, Rosebery, NSW 2018
Telephone: 02 9662 4144; Facsimile: 02 662 1720

IOSCAN AUST R 65970

Published by MIMS June 2018

BRAND INFORMATION

Brand name

Ioscan

Active ingredient

Sodium amidotrizoate

Schedule

Unscheduled

 

1 Name of Medicine

Sodium amidotrizoate.

2 Qualitative and Quantitative Composition

Ioscan is a clear, yellow, light syrupy liquid, containing sodium amidotrizoate as active ingredient, flavouring agent, preservative and sorbitol as the osmolality builder. The concentration of the diluted Ioscan solution is 1.853% w/v. Osmolality of the diluted Ioscan solution is 200 ± 20 mOsm/kg.

Ingredients.

Sodium amidotrizoate (37.05% w/v), sorbitol, D and C Yellow 10, methyl hydroxybenzoate, lemon flavour 06-0404, acesulphame potassium, citric acid anhydrous, water.

Presentation.

Sachet containing 10 mL concentrated sodium amidotrizoate solution. Each mL of the solution contains 370 mg of sodium amidotrizoate.
Plastic Bottle, 100 mL, containing 100 mL concentrated sodium amidotrizoate solution. Each mL of the solution contains 370 mg of sodium amidotrizoate.

3 Pharmaceutical Form

Dosage form: Oral Liquid, solution.
Visual description: Clear, yellow, light syrupy liquid.

4 Clinical Particulars

4.1 Therapeutic Indications

Ioscan is a contrast medium for Computerised Axial Tomography examination of the gastrointestinal tract. 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.

4.2 Dose and Method of Administration

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.

Instruction.

10 mL sachet.

Open the Ioscan sachet and pour into a 250 mL cup, fill with water to the 200 mL mark, mix with a spoon and drink. Do not store the diluted solution.

100 mL bottle.

Measure each 10 mL and dilute to 200 mL with drinking water and mix. Do not store the diluted solution.

4.3 Contraindications

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

4.4 Special Warnings and Precautions for Use

Ioscan must not be used intravascularly.
Do not use if the sachet is torn or damaged.
Use with caution in patients with asthma or a history of allergy.
Because of its iodine content, Ioscan should be used with caution in patients with hyperthyroidism.
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 (see also Paediatric use) and patients with marked electrolyte disturbances.
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 in the elderly.

No data available.

Paediatric use.

Hypertonic solution of sodium amidotrizoate have been reported to cause hypovolaemia in infants and young children, on occasions resulting in a shock-like state. Ioscan when made up according to instructions is not hypertonic, but should be used with caution in infants and young children.

Infants.

Thyroid function in infants exposed to iodinated contrast media (ICM) should be evaluated and monitored. Decreased levels of thyroxine (T4) and triiodothyronine (T3) and increased level of thyroid stimulating hormone (TSH) were reported after exposure to ICM in infants, especially preterm infants, which remained for up to a few weeks or more than a month. Thyroid function in infants exposed to ICM should therefore be evaluated and monitored until thyroid function is normalised. Some patients were treated for hypothyroidism.

Effects on laboratory tests.

Thyroid function tests based on measurement of iodine such as the protein-bound iodine test and the radioactive iodine uptake test, may be affected by iodine-containing oral contrast media. If indicated, these tests should be performed prior to use of Ioscan. Thyroid function tests not based on the presence of iodine, including triiodothyronine resin uptake test and free thyroxine test, are not affected.
Amidotrizoate sodium in the gastrointestinal tract may interfere with spectrophotometric assays of trypsin used to assess pancreatic function.
Amidotrizoates may enter the urine from the systemic circulation and interfere with some urine tests. The relevance of this to orally administered Ioscan solution is not known.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
The safety of Ioscan has not been demonstrated in pregnancy. It is known that amidotrizoates cross the placenta from the maternal circulation but the relevance of this to orally administered amidotrizoate solution is not known. Contrast radiography of the abdomen is generally contraindicated in pregnancy because of the radiation exposure involved.
Infants born to women who received iodinated contrast media while pregnant should have testing for hypothyroidism in the neonatal period. Some patients were treated for hypothyroidism. Also see Paediatric use.
 Amidotrizoate have been reported to enter the breast milk from the maternal circulation. It is possible that oral administration of Ioscan may result in low concentration of sodium amidotrizoate in the breast milk. Also see Paediatric use.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Gastrointestinal.

Common: Diarrhoea (usually mild).

Endocrine disorders.

Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and paediatric patients, including infants. Some patients were treated for hypothyroidism.
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdosage of amidotrizoate solution by oral administration has not been reported.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

No data available.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Amidotrizoates are very poorly absorbed from the gastro-intestinal tract.

Distribution.

Amidotrizoates in the circulation are not significantly bound to serum proteins.

Metabolism.

No data available.

Excretion.

If renal function is not impaired, unchanged amidotrizoate is rapidly excreted by glomerular filtration; over 95% of an intravascular dose is reported to be excreted in urine within 24 hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

10 mL sachet, 50 sachets per carton (AUSTR 65970).
100 mL bottle, 12 bottles per carton (AUSTR 80666).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Mwt 635.9, Molecular Formula C11H8I3N2NaO4.

Chemical structure.


CAS number.

737-31-5.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes