Standardised Betadine Antiseptic Solution.

Povidone Iodine 10.00% w/v.

Aqueous solution.

For use as a pre-operative and post-operative antiseptic skin cleanser for major and minor surgical procedures.

Route of administration: Topical. Adults, the elderly and children: Apply full strength as a pre-operative and post-operative antiseptic skin cleanser. Avoid pooling both under the patient and in the skin folds. Wash off excess solution before using occlusive dressings. Povidone iodine is not recommended for regular use in neonates and is contraindicated in very low birth weight infants (below 1500 grams).

Known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis). Standardised Betadine Antiseptic Solution is not recommended for body cavity irrigation.

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency. Regular use should be avoided in patients on concurrent lithium therapy.

Absorption of iodine from povidone iodine through either intact or damaged skin may interfere with thyroid function tests. Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results.

Regular use of povidone iodine should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and can be secreted into breast milk. Although no adverse effects have been reported from limited use, caution should be recommended and therapeutic benefit must be balanced against possible effects of the absorption on foetal thyroid function and development.

None known.

Povidone iodine may produce local skin reactions although it is considered to be less irritant than iodine. The application of povidone iodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function.

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Systemic absorption of iodine after repeated application of povidone iodine to large areas of wounds or burns may lead to a number of adverse effects: metallic taste in mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling of the eyes, pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea, metabolic acidosis, hypernatraemia and renal impairment.

In the case of deliberate or accidental ingestion of large quantities of Betadine, symptomatic and supportive treatment should be provided with special attention to electrolyte balance and renal and thyroid function.

Standardised Betadine Antiseptic Solution contains povidone iodine, a complex of iodine which shows all the broad spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue. Standardised Betadine Antiseptic Solution kills bacteria, viruses, fungi, spores and protozoa.

The product is intended for topical application.

None stated.

Glycerol; nonoxynol 9; dibasic sodium phosphate (anhydrous); citric acid monohydrate; sodium hydroxide; potassium iodate; purified water.

None.

36 months unopened.

Store at a temperature not exceeding 25^oC.

High-density polyethylene bottle containing 500ml of product, fitted with a white polypropylene cap with a steran-lined wad.

None stated.

Medlock Medical Limited, Tubiton House, Medlock Street, Oldham, OL1 3HS.

PL 21248/0002.

30^th March 2005.

March 2005.