PREVORA Dental solution Ref.[50410] Active ingredients: Chlorhexidine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: CHX Technologies Europe Limited, Guiness Enterprise Centre, Taylors Lane, Dublin 8, Ireland

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: A01AB Anti-infectives and antiseptics for local oral treatment
ATC Code: A01AB03 chlorhexidine

Chlorhexidine is effective against a wide range of important oral microorganisms associated with dental caries. Chlorhexidine in the drug product has been found at bactericidal levels to Streptococcus mutans for between 24 hours and 48 hours on the surface of adult dental patients after its application, as measured by HPLC.

There have been no published reports of permanent resistance by Streptococcus mutans to the repeated use of chlorhexidine for up to 2 years and no significant resistance to Streptococcus mutans or opportunistic infections with Candida albicans were observed after treatment with Prevora over one year in adult patients. The cumulative monthly mean dose of chlorhexidine delivered by Prevora 100 mg/ml Dental Solution is approximately equal to that of 1.0% w/w chlorhexidine dental gel and approximately half that of 0.2% w/v chlorhexidine oral rinse.

5.2. Pharmacokinetic properties

Chlorhexidine binds strongly to the oral mucosa and the dentition and thus has very poor systemic absorption. No detectable blood levels of chlorhexidine have been found after oral use.

5.3. Preclinical safety data

Preclinical data reveal no special hazard for humans.

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