Imidazole derivatives, topical antifungals
Brand names: Clotrimazol Cinfa, Canesten, Canespie, Mycelex
Updated · Methodology
First line
First-line for acute vulvovaginal candidiasis per CDC 2021 and Spanish SEGO 2023. Regimen: 200 mg vaginal tablet at bedtime for 3 days or 500 mg single dose, plus 1–2% cream to external genitalia twice daily for 1–2 weeks. Efficacy 80–90%. For recurrent candidiasis (>=4 episodes per year), add oral fluconazole 150 mg weekly for 6 months.
Sources
ICD-10: B37.3 · ICD-11: 1F23.10
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Clotrimazole is an imidazole antifungal. It is prescribed for cutaneous and mucosal candidiasis and other superficial mycoses (AEMPS Ficha Técnica). In alt detox circles, clotrimazole is occasionally promoted for systemic fungal cleansing in intestinal candidiasis without confirmed diagnosis. Systemic intestinal candidiasis is not recognized as an independent diagnosis in immunocompetent people in international medicine; dysbiosis as an interchangeable concept lacks agreed diagnostic criteria. In people without confirmed invasive candidiasis, no clinical studies of systemic clotrimazole prophylactic use exist, and the drug's oral bioavailability is low – it acts mainly topically. If clotrimazole was prescribed orally for systemic cleansing, consider seeking a second opinion.
Topical antifungal of the imidazole class. Inhibits fungal lanosterol 14-alpha-demethylase (CYP51), blocking ergosterol synthesis – a key fungal membrane component. Active against Candida albicans, dermatophytes (Trichophyton, Microsporum, Epidermophyton), Malassezia, Cryptococcus. Topical bioavailability is minimal (under 0.5%), no systemic effects reported.
AEMPS summary of product characteristics (section 4.6): clinical data in pregnant women are limited, and animal studies show no direct or indirect harmful effects with respect to reproductive toxicity. Because vaginal absorption of clotrimazole is limited (3 to 10%), no risks to mother or child are expected after intravaginal use in pregnancy. Clotrimazole can be used during pregnancy, but only under the supervision of a healthcare professional.
Systemic absorption is minimal. Safe during lactation, including treatment of nipple candidiasis.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Verbatim lines from the interaction sections, in the language of the label
«El uso concomitante de clotrimazol vaginal junto con tacrolimus orales (FK-506; inmunosupresores) podrían producir un aumento de los niveles plasmáticos de tacrolimus y similarmente con sirolimus…»AEMPS, section 4.5 · Open on CIMA
«El uso concomitante de clotrimazol vaginal junto con tacrolimus orales (FK-506; inmunosupresores) podrían producir un aumento de los niveles plasmáticos de tacrolimus y similarmente con sirolimus…»AEMPS, section 4.5 · Open on CIMA
«El uso concomitante de clotrimazol vaginal junto con tacrolimus orales (FK-506; inmunosupresores) podrían producir un aumento de los niveles plasmáticos de tacrolimus y similarmente con sirolimus…»AEMPS, section 4.5 · Open on CIMA
«Drug Interactions: Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.»FDA, section 7 · Open on DailyMed
«Drug Interactions: Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.»FDA, section 7 · Open on DailyMed
«Drug Interactions: Azoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.) In vitro and in vivo animal studies of the combination of amphotericin B and imidazoles suggest that…»FDA, section 7 · Open on DailyMed
«La administración conjunta de darunavir y ritonavir con otros medicamentos que inhiben el CYP3A pueden disminuir el aclaramiento de darunavir y ritonavir, lo cual provocaría un aumento de las…»AEMPS, section 4.5 · Open on CIMA
«Effects of Other Drugs on Tacrolimus: Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., erythromycin, fluconazole), calcium channel blockers (e.g., verapamil, diltiazem, nifedipine…»FDA, section 7 · Open on DailyMed
«Aunque no se han realizado estudios de interacción clínica, dado que este fármaco es metabolizado por el CYP3A4, es de esperar que ketoconazol, itraconazol, clotrimazol, ritonavir y otros inhibidores…»AEMPS, section 4.5 · Open on CIMA
«Los inhibidores del CYP3A4 pueden reducir el metabolismo de sirolimus y aumentar los niveles en sangre de sirolimus. Estos inhibidores incluyen ciertos antifúngicos (p.ej., clotrimazol, fluconazol…»AEMPS, section 4.5 · Open on CIMA
«Weak and Moderate Inducers or Inhibitors of CYP3A4 and P-gp: Drugs that could increase sirolimus blood concentrations: Bromocriptine, cimetidine, cisapride, clotrimazole, danazol, diltiazem…»FDA, section 7 · Open on DailyMed
«Recomendaciones relativas a la a dministración simultánea: Inhibidores del CYP3A4 moderados o débiles: agentes antifúngicos (p. ej., fluconazol, isavuconazol, clotrimazol, miconazol), antibióticos…»AEMPS, section 4.5 · Open on CIMA
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Clotrimazole is evaluated for the following indications with varying evidence strength: Vulvovaginal candidiasis (evidence tier A), Body detoxification and cleansing (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Clotrimazole (≥ 1 in 100): Local burning and itching at start, Skin irritation, Contact dermatitis (rare). See the Safety section for uncommon and serious reactions.
AEMPS summary of product characteristics (section 4.6): clinical data in pregnant women are limited, and animal studies show no direct or indirect harmful effects with respect to reproductive toxicity. Because vaginal absorption of clotrimazole is limited (3 to 10%), no risks to mother or child are expected after intravaginal use in pregnancy. Clotrimazole can be used during pregnancy, but only under the supervision of a healthcare professional.
Systemic absorption is minimal. Safe during lactation, including treatment of nipple candidiasis.
Clotrimazole is contraindicated in: Clotrimazole or imidazole hypersensitivity; First trimester pregnancy (vaginal forms – relative). Full list in the Safety section.
Direct links to regulator labels. Open in a new tab.
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