tolnaftate
Regulatory sources consulted
Approved indications
- Treatment of tinea pedis and corporis; prevention of tinea pedis with daily use.
Clinical warnings
- For external use only; avoid the eyes. It is not effective for tinea of the scalp or nails; stop and seek advice for irritation or no improvement after 4 weeks. — openFDA Tolnaftate topical 1% set ID 013d6107-e3b0-0264-e063-6394a90ae1e2
Pregnancy and lactation
The matching local label does not provide a specific pregnancy or breastfeeding recommendation.
Recent literature (PubMed)
Tinea pedis is one of the most common superficial fungal infections of the skin, with various clinical manifestations. This review aims to familiarize physicians with the clinical features, diagnosis and management of tinea pedis. A search was conducted in April 2023 in PubMed Clinical Queries using the key terms 'tinea pedis' OR 'athlete's foot'. The search strategy included all clinical trials, observational studies and reviews published in English within the past 10 years. Tinea pedis is most often caused by Trichophyton rubrum and Trichophyton interdigitale. It is estimated that approximately 3% of the world population have tinea pedis. The prevalence is higher in adolescents and adults than in children. The peak age incidence is between 16 and 45 years of age. Tinea pedis is more common amongst males than females. Transmission amongst family members is the most common route, and transmission can also occur through indirect contact with contaminated belongings of the affected patient. Three main clinical forms of tinea pedis are recognized: interdigital, hyperkeratotic (moccasin-type) and vesiculobullous (inflammatory). The accuracy of clinical diagnosis of tinea pedis is low. A KOH wet-mount examination of skin scrapings of the active border of the lesion is recommended as a point-of-care testing. The diagnosis can be confirmed, if necessary, by fungal culture or culture-independent molecular tools of skin scrapings. Superficial or localized tinea pedis usually responds to topical antifungal therapy. Oral antifungal therapy should be reserved for severe disease, failed topical antifungal therapy, concomitant presence of onychomycosis or in immunocompromised patients. Topical antifungal therapy (once to twice daily for 1-6 weeks) is the mainstay of treatment for superficial or localized tinea pedis. Examples of topical antifungal agents include allylamines (e.g. terbinafine), azoles (e.g. ketoconazole), benzylamine, ciclopirox, tolnaftate and amorolfine. Oral an
Topical antifungals with activity against dermatophytes include amorolfine, allylamines, azoles, ciclopiroxolamine, and tolnaftate. Polyene antimycotics, such as amphotericin B and nystatin, alternatively, miconazole are suitable for yeast infections of the skin and mucous membranes. For severe yeast infections of the skin and mucous membranes, oral triazole antimycotics, such as fluconazole and itraconazole, are used. Pityriasis versicolor is treated topically with antimycotics, and in severe forms also orally with itraconazole, alternatively fluconazole. Terbinafine, itraconazole and fluconazole are currently available for the systemic treatment of severe dermatophytoses, tinea capitis and onychomycosis. In addition to proven therapeutic regimens, unapproved (off-label use) intermittent low-dose therapies are increasingly being used, particularly in onychomycosis. Oral antimycotics for the treatment of tinea capitis and onychomycosis in children and adolescents can only be used off-label in Germany. In general, any oral antifungal treatment should always be combined with topical antifungal therapy. In tinea corporis and tinea cruris caused by Trichophyton (T.) mentagrophytes ITS (internal transcribed spacer) genotype VIII (T. indotineae), there is usually terbinafine resistance. Identification of the species and genotype of the dermatophyte and resistance testing are required. The drug of choice for T. mentagrophytes ITS genotype VIII dermatophytoses is itraconazole. In individual cases, treatment-refractory onychomycosis may be due to terbinafine resistance of T. rubrum. Here too, resistance testing and alternative treatment with itraconazole should be considered. Therapy monitoring should be carried out culturally and, if possible, using molecular methods (polymerase chain reaction). Alternative treatment options include laser application, and photodynamic therapy (PDT). Topische Antimykotika mit Wirksamkeit gegen Dermatophyten sind Amorolfin, Allylamine, Azole,
Due to the adverse effects associated with long-term administration of antifungal drugs used for treating dermatophytic lesions like tinea unguium, there is a critical need for novel antifungal therapies that exhibit improved absorption and minimal adverse effects. Nanoformulations offer a promising solution in this regard. Topical formulations may penetrate the upper layers of the skin, such as the stratum corneum, and release an appropriate amount of drugs in therapeutic quantities. Liposomes, particularly nanosized ones, used as topical medication delivery systems for the skin, may have various roles depending on their size, lipid and cholesterol content, ingredient percentage, lamellarity, and surface charge. Liposomes can enhance permeability through the stratum corneum, minimize systemic effects due to their localizing properties, and overcome various challenges in cutaneous drug delivery. Antifungal medications encapsulated in liposomes, including fluconazole, ketoconazole, croconazole, econazole, terbinafine hydrochloride, tolnaftate, and miconazole, have demonstrated improved skin penetration and localization. This review discusses the traditional treatment of dermatophytes and liposomal formulations. Additionally, promising liposomal formulations that may soon be available in the market are introduced. The objective of this review is to provide a comprehensive understanding of dermatophyte infections and the role of liposomes in enhancing treatment.
- A Review on Impurity Profiling, Degradation Studies, and Bio-Analytical Method of Anti-Fungal Drugs.
Antifungal drugs play a vital role in combating life-threatening fungal infections, yet their therapeutic effectiveness and safety critically depend on purity, stability, and reliable analytical assessment. This review comprehensively discusses impurity profiling, forced degradation studies, and bioanalytical method development of key antifungal agents within a single integrated framework - an approach not previously consolidated in the literature. The review covers major antifungal classes including azoles, polyenes, allylamines, and pyrimidine analogues. It summarizes impurity types - organic, inorganic, and residual solvents - as classified by ICH guidelines, along with their origins, formation mechanisms, and control strategies. Advanced chromatographic and spectroscopic techniques such as HPLC, LC-MS/MS, and GC-MS are highlighted for impurity detection. Forced degradation studies under ICH-recommended stress conditions are evaluated for drugs including flucytosine, terbinafine, tolnaftate, benzoic acid, and azoles. Recent advances in bioanalytical method validation using LC-MS/MS and UPLC-MS/MS for pharmacokinetic and bioequivalence studies are also outlined. The review underscores the importance of these analytical strategies in ensuring safety, efficacy, and quality control of antifungal formulations - from raw material characterization to finished product evaluation - in alignment with international pharmacopeial and ICH standards.