更新于：2024-11-04
Terbinafine Hydrochloride
盐酸特比萘芬
更新于：2024-11-04
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C21H26ClN |
InChIKeyBWMISRWJRUSYEX-SZKNIZGXSA-N |
CAS号78628-80-5 |
关联
47
项与 盐酸特比萘芬 相关的临床试验A multi-center, single-arm, open-label study to evaluate tolerability, safety, and efficacy of topical MOB015B solution in the treatment of mild to moderate distal subungual onychomycosis (DSO) in subjects aged 6-17 years - N.A.
A Multi-center, Double-blind, Randomized, Vehicle-controlled Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)
An Open Label Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Hallux Terbinafine Subungual Gel Administered to the Toenail Bed of Patients With Distal-Lateral Subungual Onychomycosis
100 项与 盐酸特比萘芬 相关的临床结果
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100 项与 盐酸特比萘芬 相关的转化医学
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100 项与 盐酸特比萘芬 相关的专利（医药）
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216
项与 盐酸特比萘芬 相关的文献（医药）2024-10-08ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
Systemic absorption and safety of topical terbinafine hydrochloride 10% solution (MOB015B): a phase 1 maximal usage trial in patients with moderate-to-severe onychomycosis
Article
作者: Gupta, Aditya K. ; DuBois, Janet C. ; Tavakkol, Amir
ABSTRACT:
Topical antifungals may be considered to treat onychomycosis with minimal risk of systemic side effects. In this study, we assess the safety, tolerability, systemic exposure, and pharmacokinetic characteristics of topical terbinafine hydrochloride 10% solution (MOB015B) in adults with moderate-to-severe onychomycosis. Clinically and mycologically confirmed patients with toenail onychomycosis (
N
= 20) were enrolled in this single-center, open-label study . Each patient had ≥50% involvement of both great toenails and at least four additional toenails affected. MOB015B was applied once daily to all toenails for 28 days. Blood was drawn on days 1, 14, and 28. Plasma concentrations of MOB015B after the first dose were quantifiable in all subjects by 24 h. Steady-state levels in plasma were reached by day 28. The mean systemic exposure on day 28 of 0.72 ng/mL for maximum plasma concentration (C
max
) was approximately 2,000 times lower than the mean plasma level of 1.39 µg/mL seen after oral administration of 250 mg terbinafine for 28 days. Adverse events (five patients), such as headache (
n
= 3), seasonal allergy (
n
= 1), and neck pain (
n
= 1), were considered unrelated to MOB015B; no application site reactions or study discontinuations due to an adverse event were observed. MOB015B applied to all affected toenails under maximal usage conditions for 28 days demonstrated very low levels of terbinafine in plasma (C
max
<1 ng/mL after 28 days), consistent with a favorable safety and tolerability profile.
CLINICAL TRIALS:
This study is registered with
ClinicalTrials.gov
as
NCT03244280
.
2024-09-01MYCOSES
Pharmacies Counselling of Patients in the Era of Antifungal Resistance
Article
作者: Skov, Kenneth ; Christensen, Elisabeth M. M. ; Saunte, Ditte M. L. ; Alcoat, Catja ; Jemec, Gregor B. E.
ABSTRACT:
Background:
Tinea pedis is one of the most prevalent superficial fungal infections. Initial antifungal treatment is often acquired over‐the‐counter (OTC) without previous consultation with a physician.
Objective:
Lately, increasing antifungal terbinafine resistance has been documented in Denmark and globally and it is therefore of interest to assess how Danish pharmacies advise customers with tinea pedis.
Methods:
One hundred Danish pharmacies were randomly selected and an employee interviewed from each. A structured question guide was followed, with the possibility to add further comments.
Results:
Interviews of 94 pharmacies were conducted. Six pharmacies never replied. Terbinafine as standard dose or cutaneous solution terbinafine one time application (Lamisil Once (R)) were recommended by 99% of the pharmacy employees as first‐line treatment. The customer was advised to seek medical attention when tinea pedis was recurring (93%), or when treatment duration was > 2 weeks (77%). The majority (88%) of the pharmacy employees had no knowledge about antifungal resistance.
Conclusion:
Only few pharmacy employees were aware of the current problem of antifungal resistance and the majority advised costumers to initiate treatment using OTC topical terbinafine. The problem of emerging antifungal resistance requires attention in order to provide customers with tinea pedis effective treatment and prevent further societal spread of resistance to antifungals.
2024-04-01Mycopathologia
Isolated Cutaneous Granuloma Caused by Candida Parapsilosis: Case Report and Literature Review
Review
作者: Yang, Zhusheng ; Jin, Xingji ; Wei, Aihua ; Wang, Youxue ; Yang, Xinyu ; Yang, Xiumin
Candidal granuloma is an uncommon type of deep chronic cutaneous candidiasis. Candida albican is the most common causative pathogen for candidal granuloma. We report herein the original case of a 69-year-old Chinese woman presented with a 3-year of painful cutaneous lesion on the back of left hand. Physical examination revealed a 4 × 5 cm large infiltrative reddish plaque with unclear boundaries. The yellow-white crusts were observed on the uneven surface of plaque. Histopathological examination of biopsy tissue revealed that yeast cells and the horizontal section of hyphae in the dermis by hematoxylin eosin staining and periodic acid-Schiff staining. Finally, the pathogen was identified as Candida parapsilosis by mycological examination and molecular identification. The patient was treated with itraconazole oral 200 mg twice daily combined with topical terbinafine hydrochloride cream for 2 months. The lesions were fully resolved and no recurrence was observed. Since the cutaneous infection caused by C. parasilosis were rarely reported, we also reviewed all 11 cases of cutaneous infection caused by C. parapsilosis in the PubMed. Our study highlighted that chronic unilateral infiltrated plaques or ulcers should be aware of the occurrence of fungal granuloma including candidal granuloma especially in immunocompromised patients.
100 项与 盐酸特比萘芬 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 体癣 | 澳大利亚 | 2003-12-22 | |
| 股癣 | 澳大利亚 | 2003-12-22 | |
| 足癣 | 美国 | 1999-03-09 | |
| 皮肤真菌病 | 中国 | 1997-01-01 | |
| 皮肤念珠菌病 | 日本 | 1993-07-02 | |
| 花斑癣 | 日本 | 1993-07-02 | |
| 头癣 | 美国 | 1992-12-30 | |
| 真菌病 | 英国 | 1990-10-03 | |
| 甲癣 | 英国 | 1990-10-03 | |
| 癣 | 英国 | 1990-10-03 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 红斑 | 临床1期 | 美国 | 2017-10-15 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | - | 夢淵製願構壓繭獵壓獵(網壓遞觸鑰選獵蓋製願) = 膚廠構窪構構製淵淵壓 網願衊窪鹹壓築鏇鬱鏇 (窪顧簾鏇鏇構鏇醖築構 ) 更多 | 非优 | 2021-07-01 | |||
vehicle | 夢淵製願構壓繭獵壓獵(網壓遞觸鑰選獵蓋製願) = 夢壓蓋齋夢簾顧繭製遞 網願衊窪鹹壓築鏇鬱鏇 (窪顧簾鏇鏇構鏇醖築構 ) 更多 | ||||||
临床3期 | 452 | 窪鹽壓壓鹽鬱餘製鬱獵(願鏇襯鬱夢衊鹹範鹽網) = 襯廠艱膚鏇願範廠憲齋 壓餘衊範觸糧蓋獵願網 (構鹹鏇齋獵鏇繭鹹窪淵 ) 更多 | 非劣 | 2020-06-25 | |||
窪鹽壓壓鹽鬱餘製鬱獵(願鏇襯鬱夢衊鹹範鹽網) = 夢鹹簾窪醖壓鑰壓繭鑰 壓餘衊範觸糧蓋獵願網 (構鹹鏇齋獵鏇繭鹹窪淵 ) 更多 |
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