Topical itraconazole formulations: Unscrupulous pharmaceutical companies and lax indian drug regulators endangering a precious drug

Verma, Shyam; Saraswat, Abir; Rao, Poonam; Dogra, Sunil

doi:10.4103/idoj.idoj_659_20

Cited by 4 publications

(2 citation statements)

References 25 publications

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“…There is compelling evidence that itraconazole is the preferred agent for Terbinafine resistant Trichophyton infections. 12,13,14 Hence,the facts of this study stand in the vicinity to the outcome of other previous studies with minor deviation to some of them.…”

Section: Discussionsupporting

confidence: 73%

Comparative study of efficacy of Terbinafine 500mg vs Terbinafine 250mg and Itraconazole 200mg in the treatment of dermatophytosis

Akter¹,

Kafi²,

Ahmed³

et al. 2022

ZHSWMCJ

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Background: Now a days superficial fungal infections become endemic in a hot humid region/tropic region like Bangladesh. In outpatient department of dermatology most of the patients come with dermatophytic infection. Most of them are maltreated or inadequately treated. We, dermatologist, are facing difficulties in treating these patients. Materials and Methods:In this study, we tried to find out the effective doses and duration of antifungal drugs Terbinafine and Itraconazole.Result: Total 92 patients with dermatophytosis of either sex aged 22-60years without any significant systemic diseases were included in this study. The patients were randomly divided into two groups; Group A and Group B. Group A was treated with Terbinafine 500mg daily and Group B was treated with combination of Terbinafine 250 mg & Itraconazole 200mg daily. Duration of treatment was for 6weeks.Itraconazole and Terbinafine containing combined groups showed significantly higher cure rates than terbinafine only groups both at 4 and 8 weeks (P < 0.001). Conclusion: combination of dailyTerbinafine 250mg with Itraconazole 200mg was more efficacious than Terbinafine 500mg

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Section: Discussionsupporting

confidence: 73%

Comparative study of efficacy of Terbinafine 500mg vs Terbinafine 250mg and Itraconazole 200mg in the treatment of dermatophytosis

Akter¹,

Kafi²,

Ahmed³

et al. 2022

ZHSWMCJ

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“…Prolonged duration of onychomycosis is associated with increased disease severity and treatment difficulty, 74 underscoring the need for supervised and consistent use of appropriate and effective antifungal agents. 75 However, patients may delay seeking a medical diagnosis or choose to treat onychomycosis with over-the-counter or natural treatments that are available without evidence from large, appropriately controlled studies demonstrating their efficacy. 76 Even with appropriate antifungal therapy, treatment of onychomycosis may take many months, 77 and may take even longer in elderly patients and for toenail versus fingernail onychomycosis.…”

Section: Clinical Resistancementioning

confidence: 99%

Treatment of onychomycosis in an era of antifungal resistance: Role for antifungal stewardship and topical antifungal agents

Gupta,

Elewski,

Joseph

et al. 2024

Mycoses

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A growing body of literature has marked the emergence and spread of antifungal resistance among species of Trichophyton, the most prevalent cause of toenail and fingernail onychomycosis in the United States and Europe. We review published data on rates of oral antifungal resistance among Trichophyton species; causes of antifungal resistance and methods to counteract it; and in vitro data on the role of topical antifungals in the treatment of onychomycosis. Antifungal resistance among species of Trichophyton against terbinafine and itraconazole—the two most common oral treatments for onychomycosis and other superficial fungal infections caused by dermatophytes—has been detected around the globe. Fungal adaptations, patient characteristics (e.g., immunocompromised status; drug–drug interactions), and empirical diagnostic and treatment patterns may contribute to reduced antifungal efficacy and the development of antifungal resistance. Antifungal stewardship efforts aim to ensure proper antifungal use to limit antifungal resistance and improve clinical outcomes. In the treatment of onychomycosis, critical aspects of antifungal stewardship include proper identification of the fungal infection prior to initiation of treatment and improvements in physician and patient education. Topical ciclopirox, efinaconazole and tavaborole, delivered either alone or in combination with oral antifungals, have demonstrated efficacy in vitro against susceptible and/or resistant isolates of Trichophyton species, with low potential for development of antifungal resistance. Additional real‐world long‐term data are needed to monitor global rates of antifungal resistance and assess the efficacy of oral and topical antifungals, alone or in combination, in counteracting antifungal resistance in the treatment of onychomycosis.

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The Emerging Terbinafine-Resistant Trichophyton Epidemic: What Is the Role of Antifungal Susceptibility Testing?

Shen

Arendrup

Verma³

et al. 2021

Dermatology

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Background: Dermatophytosis is commonly encountered in the dermatological clinics. The main aetiological agents in dermatophytosis of skin and nails in humans are Trichophyton (T.) rubrum, T. mentagrophytes and T. interdigitale (former T. mentagrophytes-complex). Terbinafine therapy is usually effective in eradicating infections due to these species by inhibiting their squalene epoxidase (SQLE) enzyme, but increasing numbers of clinically resistant cases and mutations in the SQLE gene have been documented recently. Resistance to antimycotics is phenotypically determined by antifungal susceptibility testing (AFST). However, AFST is not routinely performed for dermatophytes and no breakpoints classifying isolates as susceptible or resistant are available, making it difficult to interpret the clinical impact of a minimal inhibitory concentration (MIC). Summary: PubMed was systematically searched for terbinafine susceptibility testing of dermatophytes on October 20, 2020, by two individual researchers. The inclusion criteria were in vitro terbinafine susceptibility testing of Trichophyton (T.) rubrum, T. mentagrophytes and T. interdigitale with the broth microdilution technique. The exclusion criteria were non-English written papers. Outcomes were reported as MIC range, geometric mean, modal MIC and MIC50 and MIC90 in which 50 or 90% of isolates were inhibited, respectively. The reported MICs ranged from <0.001 to >64 mg/L. The huge variation in MIC is partly explained by the heterogeneity of the Trichophyton isolates, where some originated from routine specimens (wild types) whereas others came from non-responding patients with a known SQLE gene mutation. Another reason for the great variation in MIC is the use of different AFST methods where MIC values are not directly comparable. High MICs were reported particularly in isolates with SQLE gene mutation. The following SQLE alterations were reported: F397L, L393F, L393S, H440Y, F393I, F393V, F415I, F415S, F415V, S443P, A448T, L335F/A448T, S395P/A448T, L393S/A448T, Q408L/A448T, F397L/A448T, I121M/V237I and H440Y/F484Y in terbinafine-resistant isolates.

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Topical itraconazole formulations: Unscrupulous pharmaceutical companies and lax indian drug regulators endangering a precious drug

Cited by 4 publications

References 25 publications

Comparative study of efficacy of Terbinafine 500mg vs Terbinafine 250mg and Itraconazole 200mg in the treatment of dermatophytosis

Comparative study of efficacy of Terbinafine 500mg vs Terbinafine 250mg and Itraconazole 200mg in the treatment of dermatophytosis

Treatment of onychomycosis in an era of antifungal resistance: Role for antifungal stewardship and topical antifungal agents

The Emerging Terbinafine-Resistant <b><i>Trichophyton</i></b> Epidemic: What Is the Role of Antifungal Susceptibility Testing?

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