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ATC codes: G01AF02
Indication
Vulvovaginal candidosis ICD11 code: 1F23.10
INN
Clotrimazole
Medicine type
Chemical agent
List type
Core
Formulations
Local > Topical > Other: 1% vaginal cream ; 10% vaginal cream ; 100 mg vaginal tablet ; 500 mg vaginal tablet
EML status history
First added in 2005 (TRS 933)
Sex
All
Age
Adolescents and adults
Therapeutic equivalence
The recommendation is for this specific medicine
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
An application was received from UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, the WHO Department of Reproductive Health and Research and BMJ Knowledge, BMJ Publishing Group, London, England, to include clotrimazole (1% and 10% vaginal creams, and 100mg and 500mg vaginal tablets) for the treatment of uncomplicated candidiasis. The Committee noted that there has been adequate clinical evidence to support the efficacy and safety of topical and intravaginal clotrimazole in the treatment of vulvovaginal candidiasis. The efficacy of clotrimazole in uncomplicated candidiasis in non-pregnant women was demonstrated by four clinical trials comparing clotrimazole with placebo (1). A Cochrane review (2), based on five trials, indicated that imidazole drugs were clearly more effective than nystatin in treating vaginal candidiasis in pregnancy. Topical administration of clotrimazole is recommended by Médecins Sans Frontières and in the WHO Guidelines for the management of sexually transmitted diseases (3). The Committee therefore recommended that clotrimazole (1%, 10% vaginal cream; 100mg, 500mg vaginal tablets) be included in the Model List for the treatment of vulvovaginal candidiasis. 1. Spence D. Candidiasis (vulvovaginal). Clinical Evidence, 2004,12:2490–2508. 2. Young GL, Jewell D. Topical treatment for vaginal candidiasis (thrush) in pregnancy. Cochrane Database of Systematic Reviews 2001(3):CD000225 (http://www.cochrane.org/cochrane/revabstr/AB000225.htm, accessed 1 February 2005). 3. Guidelines for the management of sexually transmitted infections. Geneva, World Health Organization, 2003.