griseofulvin
Regulatory sources consulted
Approved indications
- Oral treatment of confirmed dermatophyte infections of skin, hair, or nails—tinea corporis, pedis, cruris, barbae, capitis, and unguium—that do not respond adequately to topical therapy. It does not treat candidiasis, tinea versicolor, or bacterial infections.
Contraindications
Absolute
- Porphyria, hepatocellular failure, or hypersensitivity to griseofulvin.
- Pregnancy or potential pregnancy during treatment.
Clinical warnings
- Major warning · May cause Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme; discontinue for a severe skin reaction. — DailyMed ultramicrosize griseofulvin set ID f21314eb-3581-4e06-9fe7-8239cc80ba11
- Major warning · May cause severe hepatotoxicity; monitor for hepatic events and consider discontinuation for elevated enzymes, bilirubin, or jaundice. — DailyMed ultramicrosize griseofulvin set ID f21314eb-3581-4e06-9fe7-8239cc80ba11
- Confirm the dermatophyte before initiation; use is not justified for mild infections that respond to topical therapy. — openFDA microsize griseofulvin set ID 1c26d7a6-17d9-4a95-a4ee-cfc5fe6bb95d
- In addition to hypersensitivity reactions, oral thrush, gastrointestinal symptoms, headache, fatigue, dizziness, insomnia, confusion, and impaired performance have been reported occasionally; paresthesia or neuropathy may be related to prolonged treatment. — DailyMed ultramicrosize griseofulvin set ID f21314eb-3581-4e06-9fe7-8239cc80ba11
- Major warning · During prolonged treatment, maintain close observation and periodically monitor renal, hepatic, and hematopoietic function. — openFDA microsize griseofulvin set ID 1c26d7a6-17d9-4a95-a4ee-cfc5fe6bb95d
- Major warning · Lupus erythematosus, lupus-like syndromes, and exacerbation of pre-existing lupus have been reported. — openFDA microsize griseofulvin set ID 1c26d7a6-17d9-4a95-a4ee-cfc5fe6bb95d
- May cause photosensitivity; avoid intense or prolonged exposure to natural or artificial sunlight. — openFDA microsize griseofulvin set ID 1c26d7a6-17d9-4a95-a4ee-cfc5fe6bb95d
Drug interactions
- HighWarfarin-type anticoagulants
Mechanism: Griseofulvin reduces anticoagulant activity through metabolic induction.
Recommendation: Monitor the anticoagulant effect and adjust during and after treatment.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f21314eb-3581-4e06-9fe7-8239cc80ba11
- HighEstrogen-containing contraceptives
Mechanism: May accelerate estrogen metabolism and reduce contraceptive effectiveness.
Recommendation: Use an alternative or additional contraceptive method during concomitant use.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f21314eb-3581-4e06-9fe7-8239cc80ba11
- ModerateCyclosporine or barbiturates
Mechanism: It may reduce cyclosporine levels; barbiturates may reduce griseofulvin levels and activity.
Recommendation: Monitor response and concentrations where appropriate; adjustment may be required.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f21314eb-3581-4e06-9fe7-8239cc80ba11
- HighAlcohol
Mechanism: Nausea, vomiting, flushing, tachycardia, and severe hypotension have been reported.
Recommendation: Avoid alcohol during treatment.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f21314eb-3581-4e06-9fe7-8239cc80ba11
- ModerateSalicylates
Mechanism: Griseofulvin may decrease serum salicylate concentrations.
Recommendation: Monitor the clinical response to the salicylate during concomitant use.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f21314eb-3581-4e06-9fe7-8239cc80ba11
Adverse events
Common (≥1%)
Skin rash or urticaria
Rare but serious
Angioedema · Stevens-Johnson syndrome or toxic epidermal necrolysis · Hepatitis or hepatic failure · Granulocytopenia or leukopenia
Pregnancy and lactation
FDA category: X (clasificación histórica de la FDA)
Contraindicated during pregnancy; it may cause fetal harm and reduce the effectiveness of estrogen-containing contraceptives. Male patients should wait at least 6 months after completing treatment before fathering a child. During breastfeeding, decide whether to discontinue nursing or the drug according to the importance of treatment to the mother.
Recent literature (PubMed)
Onychomycosis is the most common nail disease encountered in clinical practice and can cause pain, difficulty with ambulation, and psycho-social problems. A thorough history and physical examination, including dermoscopy, should be performed for each patient presenting with nail findings suggestive of onychomycosis. Several approaches are available for definitive diagnostic testing, including potassium hydroxide and microscopy, fungal culture, histopathology, polymerase chain reaction, or a combination of techniques. Confirmatory testing should be performed for each patient prior to initiating any antifungal therapies. There are several different therapeutic options available, including oral and topical medications as well as device-based treatments. Oral antifungals are generally recommended for moderate to severe onychomycosis and have higher cure rates, while topical antifungals are recommended for mild to moderate disease and have more favorable safety profiles. Oral terbinafine, itraconazole, and griseofulvin and topical ciclopirox 8% nail lacquer, efinaconazole 10% solution, and tavaborole 5% solution are approved by the Food and Drug Administration for treatment of onychomycosis in the United States and amorolfine 5% nail lacquer is approved in Europe. Laser treatment is approved in the United States for temporary increases in clear nail, but clinical results are suboptimal. Oral fluconazole is not approved in the United States for onychomycosis treatment, but is frequently used off-label with good efficacy. Several novel oral, topical, and over-the-counter therapies are currently under investigation. Physicians should consider the disease severity, infecting pathogen, medication safety, efficacy and cost, and patient age, comorbidities, medication history, and likelihood of compliance when determining management plans. Onychomycosis is a chronic disease with high recurrence rates and patients should be counseled on an appropriate plan to minimize recurrence
There has been a recent shift in the epidemiology of superficial fungal infections (tinea, dermatophytosis, dermatomycoses). Trichophyton indotineae is an emerging dermatophyte species of significant global concern for its contagious nature and antifungal drug resistance. This scoping review includes available clinical and laboratory assessments of T. indotineae to provide a comprehensive up-to-date overview of its epidemiology, clinical manifestations, diagnostic approaches, antifungal susceptibility patterns, resistance mechanisms and management strategies. We discuss T. indotineae resistance against standard and newer antifungals (terbinafine, griseofulvin and triazoles including fluconazole, itraconazole, voriconazole and posaconazole). In particular, the terbinafine susceptibility profile of T. indotineae can be linked to squalene epoxidase (SQLE) single-nucleotide variations. For diagnosis, it is not possible to separate T. indotineae from other members of the T. mentagrophytes complex (T. mentagrophytes and T. interdigitale) without access to molecular diagnostic methods. So, in patients presenting with extensive dermatophytoses, with a history of treatment resistance and/or recent travel, molecular diagnosis to confirm T. indotineae infection should be considered. Healthcare providers often face challenges in choosing between terbinafine and itraconazole treatments. While the use of terbinafine is limited due to resistance, itraconazole is hindered by erratic absorption, possible drug interactions and side effects as well as resistance in some cases. Newer treatments being investigated include super-bioavailable itraconazole, third-generation triazoles (voriconazole, posaconazole) and topical-oral combination regimens. The need for improved diagnostic accessibility, judicious antifungal prescribing, and implementing an effective antifungal stewardship program are highlighted.
Tinea capitis is a fungal infection of the scalp and hair caused by dermatophyte molds, that most often affects children and may also affect adults. Previous estimates suggest that between 3% and 11% of all tinea capitis cases worldwide occur in adults, although updated epidemiological studies are needed to reassess the prevalence of tinea capitis in adult populations specifically. Postmenopausal adult women are most often affected by tinea capitis, with African American or Black women particularly at risk. Adults who experience crowded living conditions, who live in close proximity to animals, who are immunosuppressed, and/or who live in households with affected children are at greatest risk of infection. Tinea capitis can be non-inflammatory or inflammatory in nature, and the subtype affects the extent and severity of clinical symptoms. Fungal culture and potassium hydroxide preparations are the most commonly used diagnostic tools. Trichoscopy, defined as dermoscopic imaging of the scalp and hair, is a useful adjunct to the physical examination. The mainstay of therapy is oral antifungal therapy, and topical therapy alone is not recommended. Since tinea capitis infection is uncommon in adults, there are no widely accepted treatment guidelines. Rather, the same medications used for tinea capitis infection among children are recommended for adults at varying doses, including griseofulvin, and terbinafine, and, less commonly, itraconazole and fluconazole. The prognosis for tinea capitis in adults is typically excellent when prompt and adequate treatment is administered; however, delayed diagnosis or inadequate treatment can result in scarring alopecia. Over the past decade, dermatophyte infections resistant to treatment with topical and oral antifungal agents have emerged. While tinea capitis infections resistant to antifungal therapy have been rarely reported to date, antifungal resistance is rising among superficial fungal infections in general, and antifungal stew
- Trichophyton indotineae, an Emerging Drug-Resistant Dermatophyte: A Review of the Treatment Options.
Background: Dermatophytosis is a prevalent superficial infection caused by filamentous fungi, primarily affecting the skin and/or its appendages. In recent years, there has been a notable increase in mycotic strains resistant to standard antifungal therapies, including Trichophyton indotineae, a dermatophyte of the Trichophyton mentagrophytes complex. This review aims to provide a comprehensive overview of the treatment options for T. indotineae, elucidating their effectiveness in managing this challenging mycotic infection. Methods: For this review, a search was conducted in the PubMed, Scopus, Web of Science, Embase, and Google Scholar databases, encompassing all published data until March 2024. English-language articles detailing therapy outcomes for patients confirmed to be affected by T. indotineae, identified through molecular analysis, were included. Results: Itraconazole was shown to be a good therapeutic choice, particularly when administered at a dosage of 200 mg/day for 1-12 weeks. Voriconazole was also demonstrated to be effective, while terbinafine exhibited a reduced response rate. Griseofulvin and fluconazole, on the other hand, were found to be ineffective. Although topical treatments were mostly ineffective when used alone, they showed promising results when used in combination with systemic therapy. Mutational status was associated with different profiles of treatment response, suggesting the need for a more tailored approach. Conclusions: When managing T. indotineae infections, it is necessary to optimize therapy to mitigate resistances and relapse. Combining in vitro antifungal susceptibility testing with mutational analysis could be a promising strategy in refining treatment selection.
There is an increasing number of reports of Trichophyton indotineae infections. This species is usually poorly responsive to terbinafine. A literature search was conducted in May 2024. T.indotineae infections detected outside the Indian subcontinent are generally associated with international travel. Reports of local spread are mounting.As a newly identified dermatophyte species closely related to the T. mentagrophytes complex with limited genetic and phenotypic differences, there is an unmet need to develop molecular diagnosis for T. indotineae. Terbinafine has become less effective as a first-line agent attributed to mutations in the squalene epoxidase gene (Leu393Phe, Phe397Leu). Alternative therapies include itraconazole for a longer time-period or a higher dose (200 mg/day or higher). Generally, fluconazole and griseofulvin are not effective. In some cases, especially when the area of involvement is relatively small, topical non-allylamine antifungals may be an option either as monotherapy or in combination with oral therapy. In instances when the patient relapses after apparent clinical cure then itraconazole may be considered. Good antifungal stewardship should be considered at all times. When both terbinafine and itraconazole are ineffective, options include off-label triazoles (voriconazole and posaconazole). We present four patients responding to these newer triazoles. Ringworm (dermatophytosis, tinea) is a fungal infection of the skin, hair and nails that is commonly seen by primary and secondary healthcare providers. An estimated 20–25% of the global population is affected by this condition. In Europe and the United States, tineas are often treated empirically using over-the-counter medications, which can increase the risk of resistance development.While antifungal resistance is not a new problem, this topic has garnered the attention of physicians and researchers in recent years due to an outbreak from South Asia caused by a new pathogen known as Tricho