Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Iodinated povidone
Ayrton Saunders Ltd
D08AG; D08AG02
Iodinated povidone
100 milligram(s)/millilitre
Cutaneous solution
Product not subject to medical prescription
Iodine products; povidone-iodine
Not marketed
1978-03-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine 100 mg/ml Antiseptic Paint 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Iodinated Povidone 10% w/v (yielding 1.1% w/v available iodine). For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous solution Glass bottle with applicator brush containing a brown coloured solution with an odour of alcohol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a topical antiseptic in the prevention and treatment of topical cutaneous infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration. Apply to the affected area once or twice daily or as directed. Apply directly to the affected area and allow to dry. Cover with a dressing if desired. 4.3 CONTRAINDICATIONS Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis). Use in children under two years of age. Regular use should be avoided in patients on concurrent lithium therapy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use of this preparation may interfere with tests of thyroid function. Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin and may lead to toxic levels of iodine in the blood, particularly in patients with renal insufficiency. If symptoms occur suggesting changes in thyroid function, these should be investigated. In patients with impaired renal function, blood levels of iodine should be monitored. This preparation contains alcohol and is flammable. Allow to dry after use and avoid exposure to sources of ignition. If local irritation and hypersensitivity develop, then discontinue treatment. Refer to section 4.8 for further information. Betadine Antiseptic Paint can permanently discolour white gold jewellery and it is recommended that this type of jewellery should be removed before using Betadine Antiseptic Paint. I R I S H M E D I C I N E S B O A R D ___ __ Read the complete document