BUTENAFINE

Description
Synthetic antifungal agent.

New class known as benzylamines. Structurally related to allylamines.

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MODE OF ACTION BUTENAFINE

Acetyl Coenzyme - A
Squalene
Squalene
Chromosomes

epoxidase
C-14 Demethylase

Squalene epoxide Lanosterol 14-Demethyl lanosterol Episterol Ergosterol

Squalene epoxidation [Allylamines & Benzylamines]

FINTOP
Azoles (Ketoconozole, Fluconazole, Itraconazole)

Inhibits

Sales Training Fungal cell membrane synthesis

BUTENAFINE
Description
Antifungal action is by blocking squalene epoxidation (squalene epoxidase), which results in inhibition of ergosterol synthesis. Effect is seen in concentrations.

concentrations, disrupts fungal cell membranes.

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BUTENAFINE
Description
Excellent antifungal activity & longer retention. Demonstrates significant activity against dermatophytes, yeasts & dimorphic fungi. Requires MIC for all common pathogens.

Has unique anti-inflammatory property.

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BUTENAFINE
Description
4 fold more active against T mentagrophytes & M canis than naftifine. 8 to 128 fold more active than tolnaftate, clotrimazole, or bifonazole. Elimination half life: 35 hrs.
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BUTENAFINE
Spectrum of Activity
Shows anti-microbial activity in vitro & in vivo against most strains of Dermatophytes

Epidermophyton floccosum Trichophyton mentagrophytes Trichophyton rubrum Trichophyton tonsurans Microsporum canis
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BUTENAFINE
Composition
Butenafine Hydrochloride
Cream base

1% w/w
q.s

Preservative
Sodium Benzoate IP
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0.2% w/w

BUTENAFINE
Indications & Usage
Superficial dermatophytoses. Interdigital Tinea pedis (athletes foot). Tinea corporis (ringworm) & or Tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes , T. rubrum, & T. tonsurans.
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BUTENAFINE
Contraindications
Known or suspected sensitivity to drug & its components. Not for ophthalmic, oral, or intravaginal use.

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BUTENAFINE
Carcinogenesis, Mutagenesis, & Impairment of
Fertility
Long term studies to evaluate carcinogenic potential not conducted. 6 to 12 times human topical dose did not reveal mutagenic potential.

Animals studies showed no adverse effects on male / female fertility.

Pregnancy: Category B drug.
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BUTENAFINE
Precautions
Excreted in human milk, hence caution should be exercised. Safety & efficacy in < 12 years not studied. Use in patients between 12 to 16 years is supported by adequate trials.
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BUTENAFINE
Side Effects
Burning, stinging, contact dermatitis, erythema, irritation & itching occurred in < than 2% patients.

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BUTENAFINE
Dosage & Administration
Once daily application for 4 weeks in Tinea pedis or twice daily applications for 7 days. Once daily application for 2 weeks in Tinea corporis & Tinea cruris.
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Fintop : Competition
Butop (Butenafine) Cipla
Zoderm (Oxiconazole) GSK Zimig (Terbinafine) GSK Sebifin (Terbinafine) Crosslands Terbin (Terbinafine) - Genix
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BUTENAFINE
Comparative Efficacy - Clotrimazole
TINEA PEDIS

Mycological cure rates of 95% & 88% were reported

after 4 weeks with BUTENAFINE 1% applied once daily & CLOTRIMAZOLE 1% applied twice daily

respectively, in one randomized study (Brennan &

Leyden, 1997).
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BUTENAFINE
Comparative Efficacy - Terbinafine
Dermatophytosis
BUTENAFINE 1% was more efficacious than TERBINAFINE 1% for the treatment of Tinea pedis, based on a controlled study Most frequent causative organisms were T. rubrum, T. mentagrophytes, T. violaceum, & T. tonsurans.
Syed TA, Hadi SM, Qureshi ZA et al: Butenafine 1% versus terbinafine 1% in cream for the treatment of tinea pedis; a placebocontrolled, double-blind, comparative study. Clin Drug Invest 2000; 19(6):393-397.
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CLINICAL TRIALS
Overview of topical therapy for common superficial

fungal infections & the role of new topical agents

Barbara Brennan, BSa ( Medline Lookup); James J. Leyden, MDb (Medline Lookup) Foster City, California, and Philadelphia, Pennsylvania

Both imidazole & allylamine drugs interfere with the production of ergosterol, an essential component of the fungal cell memrbane; however, the newer drugs act at an earlier stage of the metabolic pathway than the azoles & cause an accumulation of squalene in the fungal cell, which leads to cell death.
J Am Sales Training Acad Dermatol 1997 Aug;36:S3-8

CLINICAL TRIALS
The antifungal agent butenafine manifests anti-inflammatory activity in vivo.
Nahm WK, Orengo I, Rosen T Department of Dermatology, Baylor College of Medicine, Houston, Texas, USA. Dermatophyte infections are often accompanied by a striking inflammatory reaction, alleviation of which has often been achieved by the concomitant but controversial use of topical steroidal agents. Although several studies have demonstrated excellent antimycotic efficacy, none has addressed anti-inflammatory properties associated with butenafine.
J Am Acad Dermatol 1999 Aug;41(2 Pt 1):203-6
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CLINICAL TRIALS
A randomized trial to assess once-daily topical treatment of tinea corporis with butenafine, a new antifungal agent.
Greer DL, Weiss J, Rodriguez DA, Hebert AA, Swinehart JM Department of Dermatology, Louisiana State University Medical Center, New Orleans 70112, USA.

Butenafine provides rapid & persistent antifungal activity and symptom relief in patients with tinea corporis. Significant effects were observed within 7 days of therapy initiation, & increasing effectiveness was observed 4 weeks after therapy.
J Am Acad Dermatol 1997 Aug;37(2 Pt 1):231-5
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CLINICAL TRIALS
One-week therapy with twice-daily butenafine 1% cream versus vehicle in the treatment of tinea pedis: a multicenter, double-blind trial.
Savin R, De Villez RL, Elewski B, Hong S, Jones T, Lowe N, Lucky A, Reyes B, Stewart D, Willis I
Department of Dermatology, Yale University School of Medicine, New Haven, CT, USA.

Butenafine applied twice daily for 1 week is highly effective in treating interdigital tinea pedis.
J Am Acad Dermatol 1997 Feb;36(2 Pt 1):S15-9
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CLINICAL TRIALS
Butenafine 1% cream in the treatment of tinea cruris: a multicenter, vehicle-controlled, double-blind trial.
Lesher JL, Babel DE, Stewart DM, Jones TM, Kaminester L, Goldman M, Weintraub JS
Department of Medicine, Medical College of Georgia, Augusta 30912-3190, USA.

Butenafine applied once daily for 2 weeks is effective in treating tinea cruris. The proportion of patients cured increased between the end of treatment and 4 weeks after treatment.
J Am Acad Dermatol 1997 Feb;36(2 Pt 1):S20-4
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