Comparative Efficacy of Super Bioavailable Itraconazole Capsules 50 mg vs 65 mg Twice Daily in the Management of Glabrous Tinea

References

• Rengasamy M, Shenoy MM, Dogra S, et al. Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) Task Force against Recalcitrant Tinea (ITART) Consensus on the Management of Glabrous Tinea (INTACT). Indian Dermatol Online J. 2020;11(4):502–519. doi:10.4103/idoj.IDOJ_233_20
   PubMedGoogle Scholar
• Das S, De A, Saha R, et al. The current Indian epidemic of dermatophytosis: a study on causative agents and sensitivity patterns. Indian J Dermatol. 2020;65:118–122. doi:10.4103/ijd.IJD_203_19
   PubMed Web of Science ®Google Scholar
• Lindsay J, Mudge S, Thompson GR III. Effects of food and omeprazole on a novel formulation of super bioavailability itraconazole in healthy volunteers. Antimicrob Agents Chemother. 2018;62:e01723–18. doi:10.1128/AAC.01723-18
   PubMed Web of Science ®Google Scholar
• Abuhelwa AY, Foster DJ, Mudge S, Hayes D, Upton RN. Population pharmacokinetic modeling of itraconazole and hydroxyitraconazole for oral SUBA-itraconazole and Sporanox capsule formulations in healthy volunteers in fed and fasted states. Antimicrob Agents Chemother. 2015;59:5681–5696. doi:10.1128/AAC.00973-15
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. List of nationally authorised medicinal products. Available from: https://www.ema.europa.eu/en/documents/psusa/itraconazole-list-nationally-authorised-medicinal-products-psusa/00001798/201703_en.pdf. Accessed November 17, 2022.
   Google Scholar
• Mayne Pharma. TOLSURA prescribing information. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208901s000lbl.pdf. Accessed November 17, 2022.
   Google Scholar
• Central Drugs Standard Control Organization. List of drugs approved from SND Division from 01.01.2020 to 30.06.2020. Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalMarketingFDC/List%20of%20drugs%20approved%20from%20SND%20Division%20till%2030%20June%202020.pdf. Accessed November 17, 2022.
   Google Scholar
• Central Drugs Standard Control Organization. Recommendations of the SEC (Antimicrobial & Antiviral) made in its 103nd meeting held on 25.08.2021 at CDSCO HQ, New Delhi. Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/RecommendationSE%20Antimicrobial%20&%20Antiviral%2025.08.2021n.pdf. Accessed November 17, 2022.
   Google Scholar
• Mahadkar N, Dhoot DS, Barkate H. Comparative real-world effectiveness and safety of super-bioavailable itraconazole 50 mg bd and 65 mg bd in the management of dermatophytosis. Int J Res Dermatol. 2022;8:433–436. doi:10.18203/issn.2455-4529.IntJResDermatol20221567
   Google Scholar
• Rajagopalan M, Inamadar A, Mittal A, et al. Expert consensus on the management of dermatophytosis in India (ECTODERM India). BMC Dermatol. 2018;18(1):6. doi:10.1186/s12895-018-0073-1
   PubMed Web of Science ®Google Scholar
• Sarkar S. A treatise on topical corticosteroid in dermatology. Indian J Dermatol. 2018;63:530–531.
   Google Scholar
• Singh SK, Subba N, Tilak R. Efficacy of terbinafine and itraconazole in different doses and in combination in the treatment of tinea infection: a randomized controlled parallel group open labeled trial with clinico-mycological correlation. Indian J Dermatol. 2020;65:284–289. doi:10.4103/ijd.IJD_548_19
   PubMed Web of Science ®Google Scholar
• Prentice AG, Glasmacher A. Making sense of itraconazole pharmacokinetics. J Antimicrob Chemother. 2005;56(Suppl 1):i17–i22 . doi:10.1093/jac/dki220
   PubMedGoogle Scholar
• Lindsay J, Sandaradura I, Wong K, et al. Serum levels, safety and tolerability of new formulation SUBA-itraconazole prophylaxis in patients with haematological malignancy or undergoing allogeneic stem cell transplantation. J Antimicrob Chemother. 2017;72:3414–3419. doi:10.1093/jac/dkx295
   PubMed Web of Science ®Google Scholar
• Nield B, Larsen SR, van Hal SJ. Clinical experience with new formulation SUBA®-itraconazole for prophylaxis in patients undergoing stem cell transplantation or treatment for haematological malignancies. J Antimicrob Chemother. 2019;74:3049–3055. doi:10.1093/jac/dkz303
   PubMed Web of Science ®Google Scholar
• Shenoy M, Dhoot D, Mahajan H, Barkate H. An open-label, randomized, double-arm clinical trial to compare the effectiveness and safety of super bioavailable itraconazole capsules and itraconazole capsules in the management of dermatophytosis in India. Clin Cosmet Investig Dermatol. 2021;14:1367–1376. doi:10.2147/CCID.S326642
   PubMed Web of Science ®Google Scholar
• Khurana A, Agarwal A, Agrawal D, et al. Effect of different itraconazole dosing regimens on cure rates, treatment duration, safety, and relapse rates in adult patients with tinea corporis/cruris: a randomized clinical trial. JAMA Dermatol. 2022;158:1269–1278. doi:10.1001/jamadermatol.2022.3745
   PubMed Web of Science ®Google Scholar
• Ghate S, Dhoot D, Mahajan H, Barkate H. Clinical assessment of super bioavailable Itraconazole 50 mg in dermatophytosis (clear 50). IP Indian J Clin Exp Dermatol. 2021;7:125–129. doi:10.18231/j.ijced.2021.024
   Google Scholar
• Sardana K, Gupta A, Mathachan SR. Immunopathogenesis of dermatophytoses and factors leading to recalcitrant infections. Indian Dermatol Online J. 2021;12:389–399. doi:10.4103/idoj.IDOJ_503_20
   PubMedGoogle Scholar
• Rauseo AM, Mazi P, Lewis P, Burnett B, Mudge S, Spec A. Bioavailability of single-dose SUBA-itraconazole compared to conventional itraconazole under fasted and fed conditions. Antimicrob Agents Chemother. 2021;65:e0013421. doi:10.1128/AAC.00134-21
   PubMed Web of Science ®Google Scholar
• Thompson GR, Lewis P, Mudge S, Patterson TF, Burnett BP. Open-label crossover oral bioequivalence pharmacokinetics comparison for a 3-day loading dose regimen and 15-day steady-state administration of SUBA-itraconazole and conventional itraconazole capsules in healthy adults. Antimicrob Agents Chemother. 2020;64:e00400–20. doi:10.1128/AAC.00400-20
   PubMed Web of Science ®Google Scholar
• Khurana A, Agarwal A, Singh A, et al. Predicting a therapeutic cut-off serum level of itraconazole in recalcitrant tinea corporis and cruris - a prospective trial. Mycoses. 2021;64:1480–1488. doi:10.1111/myc.13367
   PubMed Web of Science ®Google Scholar
• De Doncker P, Pande S, Richarz U, Garodia N. Itraconazole: what clinicians should know? Indian J Drugs Dermatol. 2017;3:4–10. doi:10.4103/ijdd.ijdd_20_17
   Google Scholar
• Sardana K, Arora P, Mahajan K. Intracutaneous pharmacokinetics of oral antifungals and their relevance in recalcitrant cutaneous dermatophytosis: time to revisit basics. Indian J Dermatol Venereol Leprol. 2017;83:730–732. doi:10.4103/ijdvl.IJDVL_1012_16
   PubMed Web of Science ®Google Scholar
• Cauwenbergh G, Degreef H, Heykants J, Woestenborghs R, Van Rooy P, Haeverans K. Pharmacokinetic profile of orally administered itraconazole in human skin. J Am Acad Dermatol. 1988;18:263–268. doi:10.1016/S0190-9622(88)70037-7
   PubMed Web of Science ®Google Scholar
• Dhoot DS, Mahadkar N, Jain G, Kesharwani P. Comparative analysis of serum and sebum concentration of super-bioavailable itraconazole 50 versus 65 mg in healthy adult volunteers. Int J Res Dermatol. 2023;9:59–60. doi:10.18203/issn.2455-4529.IntJResDermatol20223279
   Google Scholar