Source: Base de données publique des médicaments (FR) Revision Year: 2011 Publisher: Bayer Vital GmbH, D-51368 Leverkusen Tel.: (02 14) 30 – 51348 Fax: (02 14) 30 – 51603 Email address: bayer-vital@bayerhealthcare.com
For the treatment of hyperthyroidism, for thyroid blockade in the context of radionuclide studies of other organs using radioactively labelled iodine or of immunoscintigraphy to detect tumours using antibodies labelled with radioiodine. For the detection of a congenital iodine organification defect (perchlorate discharge test).
Adults receive 4-5 × 10 Irenat drops daily (equivalent to 800-1000 mg sodium perchlorate) or, exceptionally, 5 × 15 Irenat drops daily (equivalent to 1500 mg sodium perchlorate) as an initial dose for the first 1-2 weeks. The mean maintenance dose is 4 × 5 Irenat drops (equivalent to 400 mg sodium perchlorate) per day.
Children between the ages of 6 and 14 are treated throughout with a dose of 3-6 × 1 or 4-6 × 2 Irenat drops (equivalent to 60-240 mg sodium perchlorate) daily.
When used for the perchlorate discharge test following administration of the dose of radioiodine tracer, a single dose is given of 30-50 Irenat drops (equivalent to 600-1000 mg sodium perchlorate) or 300 mg-600 mg/m² body surface area in children.
As pretreatment for radionuclide studies not involving the thyroid itself and using radioactively labelled drugs or antibodies containing iodine or technetium, Irenat drops should be administered at doses of 10–20 drops (equivalent to 200-400 mg sodium perchlorate) and, in isolated cases, up to 50 drops (equivalent to 1000 mg sodium perchlorate) so as to reduce exposure of the thyroid to radiation and to block uptake of radionuclide into certain compartments.
In view of possible gastrointestinal side effects, Irenat drops should be taken with sufficient water, preferably after eating and, on account of the short duration of action, in 4-6 divided doses over the day.
The duration of use is dependent on the indication and is guided by the clinical picture and tests of thyroid function during treatment. If remission has not occurred after 2 years of antithyroid therapy or there has already been a recurrence of the hyperthyroidism, patients should be advised of other treatment options (strumectomy/radioiodine therapy) appropriate to their age.
For thyroid blockade prior to radionuclide imaging of other organs (e.g. cerebral scintigraphy) and if radioactively labelled iodine or technetium are being used as the tracer, it is advisable for Irenat drops to be taken daily for 4 days before and, in view of the rebound phenomenon, for 2 to 3 weeks after administration of the nuclide, in combination with thiourea derivatives, to reduce exposure of the thyroid to radiation.
If Irenat drops are taken undiluted, they may (e.g. in children) have a severe local irritant effect, with symptoms such as vomiting, abdominal pain and diarrhoea.
Acute fatal intoxication with perchlorates is not known. Sodium perchlorate is tolerated in quantities of up to several grams. There is no known information on the usefulness of detoxification measures such as gastric lavage, forced diuresis, etc.
The shelf life is 4 years. Once opened, vials should not be used for longer than 26 weeks at room temperature.
This medicinal product is not to be used after the expiry date.
This medicinal product does not require any special storage conditions.
Irenat drops are available in a vial containing 40 ml solution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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