POTASSIUM IODIDE

Iodine tablets may only be taken after explicit appeal by the authority, for example via radio or television. Timing of administration It is recommended to use the tablets as soon as possible and preferably within 2 hours after the expected onset of exposure.

However, an administration up to 8 hours after the estimated onset of exposure is still useful. 5 mg iodine (¼ tablet) Pregnant and breast-feeding women (all ages): 100 mg iodine (2 tablets) Duration of administration A single administration is usually sufficient.

If the release of radioactive iodine continues (> 24 hours), with repeated exposure, intake of contaminated food or drinking water and if evacuation is not possible, a repeated administration may be necessary. 6). 6). 4). Hepatic and renal impairment No dosage adjustments are required in special populations such as patients with impaired renal or hepatic function.

Iodine elimination occurs mainly via the kidneys; however, renal elimination rate is not influenced by iodine intake or iodine serum levels. Method of administration Oral use. The tablets may be chewed or swallowed whole. Paediatric population To be able to provide the proper doses for children more easily, the tablets have got a cross break score.

For newborns and babies, the dose may be ground or dispersed in water, syrup or a similar liquid. It may take up to 6 minutes until the tablets are fully dispersed.

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Immune system disorders Not known Hypersensitivity reactions such as swollen salivary glands, headache, bronchospasm and gastro-intestinal disturbances can be mild or severe and may be dose dependent.

Endocrine disorders Not known Iodine-induced autoimmunity (Grave's and Hashimoto type), toxic nodular goitre and iodine-induced transient hyper- or hypothyroidism have been reported as side effects of iodine therapy. An overactive thyroid gland, thyroiditis, and an enlarged thyroid gland with or without development or myxoedema have also been reported.

Psychiatric disorders Not known Continued administration may lead to mental depression, nervousness, sexual impotence and insomnia. Gastrointestinal disorders Not known Sialadenitis, gastrointestinal disturbances Skin and subcutaneous tissue disorders Rare Temporary skin rash Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

Iodine prophylaxis protects against inhaled or ingested radioiodine and has no effect on other ingested radionuclides. If thyroid carcinoma is suspected, iodine administration should generally be avoided. The administration of iodine interferes with radioiodine therapy and thyroid diagnostics.

Patients undergoing thyreostatic treatment must continue with such therapy and regularly undergo medical examinations at short intervals. Patients with thyrotoxicosis treated medically, or patients with a past history of thyrotoxicosis treated medically who are now off treatment and apparently in remission, may be at risk.

The risk of iodine induced hyperthyroidism may be increased in patients with asymptomatic nodular goitre or latent Graves` disease, who are not under medical care. Pharmacological doses of iodine may cause thyroid enlargement, which in turn may aggravate airway constriction.

Potassium salts should be given cautiously to patients with renal or adrenal insufficiency, acute dehydration or heat cramp. Care should be exercised if potassium salts are given concomitantly with potassium-sparing diuretics, as hyperkalaemia may result.

In cases of exposure to radioiodine from nuclear accidents, dosing of potassium iodide should be based on emergency plans and predetermined operational intervention levels. Risk benefit of administration of stable iodine should be weighed for the different age groups at risk.

The groups most likely to benefit from treatment with iodine tablets after exposure to radioactive iodine are children, adolescents, and pregnant and breast-feeding women as well as people living in iodine deficient areas (who are more likely to be affected by exposure to radioactive iodine).

If the supply of stable iodine is limited, priority should be given to children and younger adults. Adults over 40 years of age are less likely to benefit from treatment with iodine tablets after exposure to radioactive iodine. g. emergency workers involved in rescue or clean-up operations) are likely to benefit from treatment, irrespective of their age and should be given priority.

1. - Dermatitis herpetiformis van Dühring - Hyperthyroidism - Hypocomplementaemic vasculitis