Betadine Ointment.

Povidone Iodine 10% w/w.

Ointment.

Betadine Ointment is a broad-spectrum antiseptic for the topical treatment or prevention of infection in minor cuts and abrasions, minor surgical procedures and small areas of burns. Treatment of mycotic and bacterial skin infections and pyodermas. Treatment of infections in decubitus and stasis ulcers.

Route of administration: Topical. For the treatment of infection: Apply once or twice daily for a maximum of 14 days. For the prevention of infection: Apply once or twice a week for as long as necessary. The affected skin should be cleaned and dried. Apply Betadine Ointment to the affected area. May be covered with a dressing or bandage. Not for use in children under two years of age.

Known or suspected iodine hypersensitivity. Regular use is contraindicated in patients and users with thyroid disorders (in particular nodular colloidal goitre, endemic goitre and Hashimoto's thyroiditis). Not for use in children under two years of age.

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. Thyroid function tests should be performed during prolonged use.

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.

Treatment: 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.

Povidone iodine is a complex of iodine, which retains the broad-spectrum germicidal activity of elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue.

Betadine Ointment is applied topically to the affected area.

Not applicable.

Polyethylene glycol 4000; polyethylene glycol 1000; polyethylene glycol 1500; purified water; sodium bicarbonate; polyethylene glycol 400.

None.

36 months unopened.

Store at or below 25^oC.

Triple epoxy lacquered aluminium tubes with polyethylene closures containing 20 or 80g of product.

None stated.

Seton Healthcare Group plc, Tubiton House, Oldham, OL1 3HS.

PL 0223/0015.

21^st July 1993 / 11^th November 2003.

November 2003.