Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
Potassium iodide is indicated as a thyroid-blocking agent to prevent the uptake of radioactive iodine, for example after a nuclear accident or during a nuclear medicine investigation before administering a radioiodinated compound, which is metabolised to iodide or which contains radioiodine impurities.
Iodine prophylaxis should be performed in case of a nuclear accident, when radioactive iodine is released, in all people involved including children and pregnant and breastfeeding women located in the endangered area. People with known iodine sensitivity or with a history of active treatment of thyroid disorders should consult their physician. When the nuclear accident is announced the required doses of potassium iodide are as follows:
| Age group | Tablets | Iodine equivalent |
|---|---|---|
| Neonates up to 1 month of age | Quarter of a tablet | 16 mg potassium iodide equivalent to 12.5 mg iodine |
| Children from 1 month to 3 years of age | Half a tablet | 32 mg potassium iodide equivalent to 25 mg iodine |
| Children from 3 to 12 years of age | 1 tablet | 65 mg potassium iodide equivalent to 50 mg iodine |
| Children from 12 years of age, adults and elderly | 2 tablets | 130 mg potassium iodide equivalent to 100 mg iodine |
A single daily dose should be administered. This will protect against exposure lasting up to 24 hours (see section 4.4).
Owing to the sensitivity of the neonate and foetus thyroid to large doses of iodine, repeated administration of stable iodine should be avoided for neonates and pregnant and lactating women. Neonates will not require further doses. Pregnant and breastfeeding women should take a maximum of two doses.
For children the medicine may be crushed and mixed with milk, water or juice before administration.
When ThySat 65 mg tablets are used as a blocking agent before administering a radioiodinated compound, which is metabolised to iodide or which contains radioiodine impurities, an oral dose of 130 mg (2 tablets) in adults will reduce thyroid uptake to less than 1% of normal. This dose should be administered on or before the day of the investigation and then daily until the estimated activity of radioiodine in the body has fallen to appropriate levels.
In children of 3 to 12 years 50% of the adult dose should be given and in children of 1 month to 3 years the dose should be 25% of the adult dose.
Potassium iodide should not be given when radioiodine is being administered for the purpose of diagnostic imaging or treatment of the thyroid gland.
For oral administration.
In overdose, symptoms of iodism such as headache, pain and swelling of the salivary glands, fever or laryngitis, swelling or inflammation of the throat, gastrointestinal upset and diarrhoea can occur. Pulmonary oedema can also occur.
Acute ingestion of iodine can result in corrosive injury of the gastrointestinal tract and renal damage. Cardiopulmonary collapse due to circulatory failure should be treated by maintenance of airway and stabilisation of the circulation. Oedema of the glottis resulting in asphyxia or aspiration pneumonia can occur.
Gastric lavage should not be considered due to the possibility of corrosive injury. Activated charcoal may be considered in iodide poisoning if the patient presents within 1 hour of ingestion. Give milk or starch-based food.
6 years.
Do not store above 25°C.
Keep the blister in the outer carton in order to protect from light and moisture.
Blister (white, opaque PVC/PVDC foil / Al foil with printing), package insert leaflet, outer paper folder.
Size of packing: 4, 10 or 100 tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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