terbinafine
Sources réglementaires consultées
Indications approuvées
- Onychomycose des ongles des mains ou des pieds due aux dermatophytes, confirmée par prélèvement unguéal.
Contre-indications
Absolues
- Maladie hépatique chronique ou active.
- Antécédent de réaction allergique à la terbinafine orale.
Mises en garde cliniques
- Mise en garde majeure · Des insuffisances hépatiques, transplantations et décès sont survenus. Doser les transaminases avant le traitement, surveiller périodiquement et arrêter en cas d’atteinte hépatique. Arrêter aussi en cas de trouble grave du goût ou de l’odorat, de neutrophiles ≤1 000/mm³ ou de réaction cutanée grave. — openFDA terbinafine tablets 250 mg set ID 085e0809-6b7f-447e-976e-8276c29daad6
- Mise en garde majeure · Un purpura thrombotique thrombocytopénique et un syndrome hémolytique et urémique, y compris des cas mortels, ont été rapportés ; arrêter en présence de signes compatibles. Une induction ou une exacerbation d'un lupus érythémateux et des symptômes dépressifs ont également été rapportés ; évaluer et arrêter selon la gravité. — openFDA terbinafine tablets 250 mg set ID 085e0809-6b7f-447e-976e-8276c29daad6
Interactions médicamenteuses
- SévèreSubstrats du CYP2D6
Mécanisme: La terbinafine inhibe le CYP2D6 et peut augmenter l’exposition aux antidépresseurs tricycliques, ISRS, bêtabloquants, antiarythmiques de classe 1C et inhibiteurs de la MAO-B.
Recommandation: Surveiller étroitement et envisager de réduire la dose du substrat.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=584d1fae-0120-49a0-e063-6394a90a36fc
- SévèreRifampicine
Mécanisme: Elle double approximativement la clairance de la terbinafine.
Recommandation: Surveiller une éventuelle perte d’efficacité et n’ajuster que sous supervision clinique.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=584d1fae-0120-49a0-e063-6394a90a36fc
- ModéréeFluconazole
Mécanisme: Il augmente l’exposition à la terbinafine par inhibition des CYP2C9 et CYP3A4.
Recommandation: Surveiller la toxicité ; considérer aussi ce risque avec des inhibiteurs doubles similaires.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=584d1fae-0120-49a0-e063-6394a90a36fc
- ModéréeCimétidine
Mécanisme: La cimétidine a diminué la clairance de la terbinafine de 33 % et peut augmenter son exposition.
Recommandation: Surveiller les effets indésirables de la terbinafine et envisager un ajustement sous supervision clinique.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=584d1fae-0120-49a0-e063-6394a90a36fc
- ModéréeCiclosporine
Mécanisme: La terbinafine a augmenté la clairance de la ciclosporine de 15 % et peut réduire son exposition.
Recommandation: Surveiller les concentrations de ciclosporine et la réponse clinique ; ajuster sous supervision si nécessaire.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=584d1fae-0120-49a0-e063-6394a90a36fc
- ModéréeCaféine
Mécanisme: La terbinafine a diminué la clairance de la caféine intraveineuse de 19 % et peut augmenter ses effets.
Recommandation: Surveiller les effets stimulants et envisager de réduire la consommation de caféine s’ils surviennent.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=584d1fae-0120-49a0-e063-6394a90a36fc
- SévèreWarfarine
Mécanisme: Des augmentations ou diminutions du temps de prothrombine ont été rapportées lors de l’utilisation concomitante ; aucun lien causal n’a été établi.
Recommandation: Surveiller le temps de prothrombine ou l’INR lors de l’instauration, de l’arrêt ou d’une modification de la terbinafine.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=584d1fae-0120-49a0-e063-6394a90a36fc
Effets indésirables
Communs (≥1%)
Céphalées · Diarrhée ou dyspepsie · Éruption ou prurit · Trouble du goût · Nausées ou douleur abdominale · Anomalie des enzymes hépatiques
Rares mais graves
Insuffisance hépatique · Anaphylaxie ou angio-œdème · Neutropénie grave ou pancytopénie · Syndrome de Stevens-Johnson, nécrolyse épidermique toxique ou DRESS
Grossesse et allaitement
Les données pendant la grossesse sont insuffisantes. La terbinafine orale est présente dans le lait humain ; mettre en balance les bénéfices de l’allaitement, le besoin maternel et les effets possibles chez le nourrisson.
Bibliographie récente (PubMed)
Dermatophytes represent the largest and most common group of fungal infections, impacting 25% of the global population. Among them, Trichophyton rubrum has emerged as the predominant species, responsible for a range of conditions such as tinea corporis, tinea pedis, onychomycosis, tinea cruris, and tinea manuum. Although dermatophyte incidence varies geographically, there is a noticeable rise in cases caused by T. indotineae, a strain that exhibits resistance to terbinafine. In the past decade zoophilic dermatophyte T. mentagophytes genotype VII (now known as T. interdigitale) gains a growing importance, due to its increasing frequency, the severity of the clinical manifestation and mode of transmission. Tinea infections present with various clinical symptoms and can affect individuals of all ages, from tinea pedis in adults to tinea capitis in children. Among adults globally, tinea unguium (onychomycosis) is the most common form of dermatophytosis, affecting 5.5% of the general population. Tinea unguium is more frequently seen in developed countries, while tinea capitis is more common in developing nations. The COVID-19 pandemic has led to an increase in cases of tinea faciei, likely due to prolonged mask-wearing. Terbinafine remains the preferred treatment for dermatophyte infections worldwide due to its potent fungicidal properties, minimal risk of drug interactions, and fewer side effects compared to other oral antifungals. Itraconazole and terbinafine appear to be equally effective and safe for treating tinea cruris and tinea corporis. However, the rising resistance of dermatophytes to these antifungal drugs, along with frequent recurrences of dermatophytosis in certain regions, is becoming a significant public health concern.
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
Onychomycosis is a common chronic fungal infection of the nail that causes discoloration and/or thickening of the nail plate. Oral agents are generally preferred, except in the case of mild toenail infection limited to the distal nail plate. Terbinafine and itraconazole are the only approved oral therapies, and fluconazole is commonly utilized off-label. Cure rates with these therapies are limited, and resistance to terbinafine is starting to develop worldwide. In this review, we aim to review current oral treatment options for onychomycosis, as well as novel oral drugs that may have promising results in the treatment of onychomycosis.
Tinea versicolor is a common superficial fungal infection of the skin with various clinical manifestations. This review aims to familiarize physicians with the clinical features, diagnosis and management of tinea versicolor. A search was conducted in July 2022 in PubMed Clinical Queries using the key terms "tinea versicolor" OR "pityriasis versicolor". The search strategy included all clinical trials, observational studies and reviews published within the past 10 years. Tinea versicolor is caused by Malassezia species, notably M. globosa, M. furfur and M. sympodialis. The condition is characterized by scaly hypopigmented or hyperpigmented macules/patches, primarily located on the upper trunk, neck and upper arms. The diagnosis is usually based on characteristic clinical features. If necessary, a potassium hydroxide preparation test can be performed to reveal numerous short, stubby hyphae intermixed with clusters of spores. Most patients with tinea versicolor respond to topical antifungal therapy, which has a better safety profile (fewer adverse events, fewer drug interactions) and lower cost compared to systemic treatment and is therefore the treatment of choice. Oral antifungal therapy is typically reserved for patients with extensive disease, frequent recurrences or disease that is refractory to topical therapy. Advantages of oral antifungal therapy include increased patient compliance, shorter duration of treatment, increased convenience, less time involved with therapy and reduced recurrence rates. On the other hand, oral antifungal therapy is associated with higher cost, greater adverse events and potential drug-drug interactions and is therefore not the first-line treatment for tinea versicolor. Long-term intermittent prophylactic therapy should be considered for patients with frequent recurrence of the disease. Selection of antifungal agents depends on several factors, including efficacy, safety, local availability, ease of administration, likelihood of compl
Seborrheic dermatitis (SD) is a common chronic inflammatory skin disorder that mostly affects young adults in areas rich in sebaceous glands (scalp, face, and trunk). In adolescents and adults, SD clinical presentation may range from mild patches to diffuse scalp scaling. In infants, it mainly occurs on the scalp as yellowish, scaly patches ("cradle cap"). In adults, several environmental triggers are likely to promote SD development, along with fungal colonization by Malassezia spp., sebaceous gland activity, as well as immunosuppression, endocrine, neurogenic and iatrogenic factors. In children, early occurrence in the first trimester suggests the role of excessive sebaceous gland activity from maternal hormones, along with cutaneous microbiome alterations. The diagnosis of SD is usually clinical, and specific laboratory and/or instrumental investigations are seldom required. Treatment is aimed at modulating sebum production, reducing skin colonization by Malassezia spp., and controlling inflammation. In adults, mild-to-moderate scalp SD forms can be managed with topical antifungals (ketoconazole, ciclopirox, miconazole) or antiinflammatory (mild-to-moderate potency corticosteroids) or keratolytic/humectant (propylene glycol) agents. Recommended topical therapeutic options for mild-to-moderate facial or body areas SD include topical ketoconazole, ciclopirox, clotrimazole, mild-to-moderate potency corticosteroids, lithium succinate/gluconate, and topical calcineurin inihibitors (off-label use). In severe and/or resistant cases, the use of systemic antifungal drugs (terbinafine, itraconazole), as well as UVB phototherapy, may be considered. In children, scant scientific evidence supports the effectiveness and safety of topical drugs, and "cradle cap" is usually successfully managed with baby shampoos enriched with emollient agents and vegetable oils. Alternatively, similarly to adult scalp SD, medical device shampoos with antiinflammatory and antifungal properties,