SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Betadine Surgical Scrub.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Povidone Iodine 7.5% w/v.

3    PHARMACEUTICAL FORM

Surgical Scrub.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For use as an antiseptic skin cleanser for:

1.    Pre-operative scrubbing and washing by surgeons and theatre staff.

2.    Pre-operative preparation of patients skin.

4.2 Posology and method of administration

For topical administration.

Adults

Apply full strength as a pre-operative antiseptic skin cleanser.

Children and the Elderly As for adults

Povidone iodine is not recommended for regular use in neonates and is contraindicated in very low birth weight infants (below 1500 grams)

4.3 Contraindications

1.	Known or suspected to iodine hypersensitivity.
2.	Regular use is in patients and users with thyroid disorders (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).

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 used for long periods thyroid function tests should be performed. Particular care should be taken when treating patients with excessive burns. Use of this preparation In patients with renal impairment may possibly result in the development of toxic levels of iodine" Therefore, iodine levels should be monitored in these patients. Particular care should also be taken when treating neonates and very low birth weight infants.

Betadine Surgical Scrub can permanently discolour white gold jewellery and it is recommended that this type of jewellery should be removed before using Betadine Alcoholic Solution.

Avoid contact with eyes. In case of contact with the eyes, immediately flush the eyes liberally with water for at least 15 minutes and seek medical attention. If easy to do, remove contact lenses.

4.5 Interaction with other medicinal products and other forms of interaction

Use with concurrent lithium therapy has been shown to exhibit additive hypothyroidic effects. Absorption of iodine from povidone iodine through either intact skin or broken 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.

4.6 Fertility, Pregnancy and lactation

Iodine freely crosses the placenta and is secreted in breast milk. Therefore it is recommended that breastfeeding should stop during treatment, unless no alternative is possible. Thyroid function disorders have been reported in the offspring of mothers exposed to pharmacological doses of iodine. Povidone iodine should not be used regularly during pregnancy unless there is no alternative treatment available.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Local irritation, skin burns and sensitivity reactions have been reported rarely. Anaphylactic reactions, anaphylactoid reactions and anaphylactic shock have been reported uncommonly with products containing povidone-iodine or povidone.

Excess iodine can produce goitre and hypothyroidism or hyperthyroidism. Such effects have occasionally been seen with extensive or prolonged use of povidone iodine. Other effects that have been reported are metabolic acidosis and acute renal failure.

4.9 Overdose

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.

Deliberate or accidental ingestion of large quantities of povidone iodine will result in high blood levels of iodine and gastrointestinal toxicity including vomiting and diarrhoea. Symptomatic and supportive treatment should be started with special attention to monitoring electrolyte balance, renal function, thyroid function and liver function. Iodine can be removed by dialysis.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The active ingredient, povidone-iodine slowly liberates iodine when in contact with skin and mucous membranes. The activity of 'iodine' as a microbicide is then governed by a series of dissociations.

I2 «• I+ + I^-

I2 + H₂O «• H₂O I+ + I^-

The microbicidal species H2O I+ preferentially displaces O2 as the end

electron acceptor in the micro organisms respiratory cycle. H2O I+ similarly

interacts within the electron transport chain and reacts with the amino acids of the microbial cell membrane.

5.2 Pharmacokinetic properties

Betadine Surgical Scrub is for topical application and therefore a consideration of the ADME of povidone-iodine is largely without relevance.

5.3 Preclinical safety data

None stated.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sulphated Nonylphenoxypoly (oxyethylene) ethanol ammonium salt Lauric diethanolamide Ethoxylated Lanolin 50%

Hydroxyethylcellulose Sodium Hydroxide Purified Water

6.2 Incompatibilities

None stated.

6.3    Shelf life

36 months unopened