SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Betadine Alcoholic Solution.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Povidone iodine 10% w/v.

3 PHARMACEUTICAL FORM

Alcoholic solution.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For use as an antiseptic skin cleanser for major and minor surgical procedures where a quick drying effect is desired.

4.2 Posology and method of administration

Topical administration.

4.3 Contraindications

Hypersensitivity to iodine, polyvinylpyrrolidine or to any excipient. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis). 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 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^-

I² + I^- ^ I3^-

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 alcoholic solution is for topical application and therefore a consideration of the ADME of povidone iodine is largely without relevance.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Nonoxynol 9

Dibasic sodium phosphate (anhydrous)

Citric acid, monohydrate Glycerol

Industrial methylated spirit Sodium hydroxide Purified water.

6.2 Incompatibilities

None.

6.3 Shelf life

36 months unopened.

6.4 Special precautions for storage

To be stored at or below 25°C and protected from light.

6.5 Nature and contents of container

High density polyethylene containers with steran lined white polypropylene caps. Pack sizes: 500m1 and 5 litres.

6.6 Special precautions for disposal

None stated.

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