Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Pharmacotherapeutic group: Antiinfectives and antiseptics for local oral treatment
ATC code: A01AB12
Hexetidine is a broad spectrum antimicrobial. It is active both in vivo and in vitro, against gram positive and negative bacterium, as well as yeasts (Candida albicans) and fungi.
Specific pharmacodynamic studies have not been carried out on ORALDENE in man.
The oral retention of hexetidine to mucous membranes and dental plaque has been observed. In studies using radiolabelled hexetidine it has been shown that retention on buccal tissues can extend to between 8 and 10 hours after a single oral rinse and in some cases hexetidine has been detected on oral tissues up to 65 hours post-treatment.
No absorption studies following the topical application of ORALDENE have been performed in man.
There have been no specific studies of ORALDENE or hexetidine in renal/hepatic impairment.
There have been no specific studies of ORALDENE or hexetidine in the elderly.
Pre-clinical safety data do not add anything of further significance to the prescriber.
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