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Butenafine: Drug information

Butenafine: Drug information
(For additional information see "Butenafine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Lotrimin Ultra [OTC];
  • Mentax [DSC]
Pharmacologic Category
  • Antifungal Agent, Topical
Dosing: Adult
Tinea infections

Tinea infections:

Tinea corporis/tinea cruris: Topical: Cream 1%: Apply to affected and surrounding area(s) once daily until clinical resolution, typically 1 to 3 weeks (Ref).

Tinea pedis (labeled use)/tinea manuum (off-label use): Topical: Cream 1%: Apply to affected and surrounding area(s) once or twice daily until 1 week after clinical resolution, typically for 2 weeks (twice daily) or 4 weeks (once daily) total (Ref).

Tinea versicolor (pityriasis versicolor): Topical: Cream 1%: Apply to affected area(s) and immediate surrounding skin once daily for 2 weeks (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

≥1%: Dermatologic: Burning sensation of skin, contact dermatitis, erythema, pruritus, skin irritation, stinging of the skin

Contraindications

Hypersensitivity to butenafine or any component of the formulation

OTC labeling: When used for self-medication, do not use on nails or scalp, in or near the mouth or eyes, or for vaginal yeast infections

Warnings/Precautions

Concerns related to adverse effects:

• Allylamine antifungal hypersensitivity: Use caution in patients sensitive to allylamine antifungals (eg naftifine, terbinafine); cross sensitivity to butenafine may exist.

• Irritation: Discontinue if sensitivity or irritation occurs.

Special populations:

• Immunocompromised patients: Has not been studied in immunocompromised patients.

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with eyes, mouth, nose, or other mucous membranes.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External, as hydrochloride:

Lotrimin Ultra: 1% (12 g, 30 g [DSC]) [contains benzyl alcohol, cetyl alcohol, propylene glycol, sodium benzoate, trolamine (triethanolamine)]

Mentax: 1% (15 g [DSC], 30 g [DSC]) [contains benzyl alcohol, sodium benzoate]

Generic: 1% (12 g, 30 g)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Butenafine HCl External)

1% (per gram): $0.67

Cream (Lotrimin Ultra External)

1% (per gram): $0.90

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Topical: For external use only; avoid contact with eyes, mouth, nose, or other mucous membranes. Apply to clean, dry skin. Avoid occlusive dressings.

Tinea pedis: Wear well-fitted, ventilated shoes; change socks and shoes at least once daily.

Administration: Pediatric

Topical: For external use only; avoid contact with eyes, mouth, nose, or other mucous membranes. Apply to clean, dry skin. Avoid occlusive dressings. Wash hands after each use.

Use: Labeled Indications

Topical infections: Topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur

OTC labeling: Topical treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm)

Use: Off-Label: Adult

Tinea manuum

Medication Safety Issues
Sound-alike/look-alike issues:

Lotrimin may be confused with Lotrisone

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Adverse effects were not observed in animal reproduction studies.

Breastfeeding Considerations

It is not known if butenafine is excreted in breast milk. The manufacturer recommends that caution be exercised when administering butenafine to nursing women.

Monitoring Parameters

Culture and KOH exam, clinical signs of tinea pedis

Mechanism of Action

Butenafine exerts fungicidal activity against dermatophytes (eg trichophyton, epidermophyton) by blocking squalene epoxidation, resulting in inhibition of ergosterol synthesis and subsequent weakening of fungal cell membranes.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Minimal systemic

Metabolism: Hepatic via hydroxylation

Half-life elimination: Biphasic: Alpha: 35 hours; Beta: >150 hours

Time to peak, serum: 6 to 15 hours

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Butafyl;
  • (AR) Argentina: Buticrem;
  • (BD) Bangladesh: Butefin | Fintop | Tenafin;
  • (BR) Brazil: Tefin;
  • (CL) Chile: Dermacom;
  • (CN) China: Jia rui | Jie ning | Mai ke shu | Te li da;
  • (CO) Colombia: Butemax;
  • (DO) Dominican Republic: Butefin;
  • (EC) Ecuador: Fintop;
  • (EE) Estonia: Mentax;
  • (EG) Egypt: Butaximark | Fungestic | Mentax | Mycovrex | Tinearest;
  • (ID) Indonesia: Dermax;
  • (IL) Israel: Mentax;
  • (IN) India: Butenaskin | Butifun | Butop | Exebute | Fintop | Kutica;
  • (JO) Jordan: Mentax;
  • (JP) Japan: Butenafine HCL | Butenarock | Lamaston mx | Mentax | Meridam | Scorba dash | Volley;
  • (KR) Korea, Republic of: Butena | Butenil | Danafin | Mentax | Nanopin;
  • (LT) Lithuania: Mentax;
  • (LV) Latvia: Mentax;
  • (MX) Mexico: Derfina | Lexoderil;
  • (PE) Peru: Butenfit;
  • (PH) Philippines: Butenafine HCL | Funcid;
  • (PR) Puerto Rico: Athlete's foot | Lotrimin ultra | Mentax;
  • (SA) Saudi Arabia: Butafyl | Derfina;
  • (TR) Turkey: Butafly | Butefin | Butegal;
  • (TW) Taiwan: Ankorme | Antimax | Benafine | Bunafine | Butederm | Butefine | Butemax | Emould | Mentax | Sanmasu | Sergen | Sumelo | Superin | Udaxen;
  • (UG) Uganda: Fintop
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  7. Mentax (butenafine hydrochloride cream) [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals Inc; June 2018.
  8. Refer to manufacturer's labeling.
  9. Reyes BA, Beutner KR, Cullen SI, et al, “Butenafine, a Fungicidal Benzylamine Derivative, Used Once Daily for the Treatment of Interdigital Tinea Pedis,” Int J Dermatol, 1998, 37(6):450-3. [PubMed 9646136]
  10. Savin R, De Villez RL, Elewski B, et al. One-week therapy with twice-daily butenafine 1% cream versus vehicle in the treatment of tinea pedis: a multicenter, double-blind trial. J Am Acad Dermatol. 1997;36(2, pt 1):S15-S19. doi:10.1016/s0190-9622(97)70317-7 [PubMed 9039200]
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  13. Tschen E, Elewski B, Gorsulowsky DC, et al, “Treatment of Interdigital Tinea Pedis With a 4-Week Once-Daily Regimen of Butenafine Hydrochloride 1% Cream,” J Am Acad Dermatol, 1997, 36(2 Pt 1):S9-14. [PubMed 9039199]
  14. van Zuuren EJ, Fedorowicz Z, El-Gohary M. Evidence-based topical treatments for tinea cruris and tinea corporis: a summary of a Cochrane systematic review. Br J Dermatol. 2015;172(3):616-641. doi:10.1111/bjd.13441 [PubMed 25294700]
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