1. Name Of The Medicinal Product
Betadine Gargle and Mouthwash.
2. Qualitative And Quantitative Composition
Povidone Iodine USP 1% w/v (equivalent to 0.1% w/v of available iodine).
3. Pharmaceutical Form
Solution.
4. Clinical Particulars
4.1 Therapeutic Indications
For the treatment of acute mucosal infections of the mouth and pharynx, for example gingivitis, and mouth ulcers. For oral hygiene prior to, during and after dental and oral surgery.
4.2 Posology And Method Of Administration
For oral administration, as a gargle and mouthwash. The product should not be swallowed. Adults and children over 6 years of age: Use undiluted or diluted with an equal volume of warm water. Gargle or rinse with up to 10ml for up to 30 seconds without swallowing. Repeat up to four times daily, for up to 14 consecutive days, or as directed.
4.3 Contraindications
Not for use in children under 6 years of age and in patients with a 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
Regular use should be avoided as prolonged use may lead to the absorption of a significant amount of iodine. Do not use for more than 14 days. If sores or ulcers in the mouth do not heal within 14 days, seek medical or dental advice. Regular use should be avoided in patients on concurrent lithium therapy.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Absorption of iodine from povidone iodine 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 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. The use of Betadine Gargle and Mouthwash in pregnant and lactating women should be limited to a single treatment session only.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Idiosyncratic mucosal irritation and hypersensitivity reactions may occur. Excessive absorption of iodine may produce systemic effects such as metabolic acidosis, hypernatraemia and impairment of renal function.
4.9 Overdose
Excessive iodine can produce goitre and hypothyroidism or hyperthyroidism. Acute overdose may result in symptoms of metallic taste in the mouth, increased salivation, burning or pain in the throat or mouth, irritation and swelling in the eyes, difficulty in breathing due to pulmonary oedema, skin reactions, gastrointestinal upset and diarrhoea. Metabolic acidosis, hypernatraemia and renal impairment may occur. Treatment: In the cases 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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Betadine Gargle and Mouthwash 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. Betadine Gargle and Mouthwash kills bacteria, viruses, fungi, spores and protozoa.
5.2 Pharmacokinetic Properties
The product is intended for topical application to the mouth and buccal cavity.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Glycerol; menthol; methyl salicylate; ethanol 96%; saccharin sodium; purified water.
6.2 Incompatibilities
None stated.
6.3 Shelf Life
36 months unopened.
6.4 Special Precautions For Storage
Store in a dry place below 25oC. Protect from light.
6.5 Nature And Contents Of Container
Amber soda-lime-silica glass bottle (USP Type III) fitted with an externally ribbed white urea cap, with a steran faced wad or with a wadless polypropylene cap containing 250ml of product.
6.6 Special Precautions For Disposal And Other Handling
This product should not be swallowed.
7. Marketing Authorisation Holder
Medlock Medical Limited, Tubiton House, Oldham, OL1 3HS.
8. Marketing Authorisation Number(S)
PL 21248/0006.
9. Date Of First Authorisation/Renewal Of The Authorisation
30th September 2005.
10. Date Of Revision Of The Text
September 2005.
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