Betadine Alcoholic Solution (Molnlycke Health Care )

1. Name Of The Medicinal Product

Betadine Alcoholic Solution.

2. Qualitative And Quantitative Composition

Povidone iodine 10.0% 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

For topical administration.

4.3 Contraindications

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).

4.4 Special Warnings And Precautions For Use

Special caution is needed when regular applications to broken skin are made to patients with pre-existing renal insufficiency.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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.

4.6 Pregnancy And Lactation

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 of iodine on foetal thyroid function and development.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

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.

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. Treatment: In the case of 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.

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 oxygen as the end electron acceptor in the microorganism's 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 absorption, distribution, metabolism and excretion 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.

6.4 Special Precautions For Storage

To be stored at or below 25 degrees Celsius and protected from light.

6.5 Nature And Contents Of Container

High-density polyethylene containers fitted with steran lined white polypropylene caps. Pack size: 500ml

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

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

8. Marketing Authorisation Number(S)

PL 21248/0002.

9. Date Of First Authorisation/Renewal Of The Authorisation

14^th March 2005.

10. Date Of Revision Of The Text

March 2005.