Embedded Files
Pharmacologic Category
Dosing: Adult
Tinea corporis, tinea cruris: Topical: Apply once daily for 2 weeks to affected area
Tinea versicolor: Topical: Apply once daily for 2 weeks to affected area and surrounding skin
Tinea pedis: Topical: Apply twice daily for 1 week or once daily for 4 weeks to affected skin between and around the toes
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal 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: Pediatric
Children ≥12 years and Adolescents: Refer to adult dosing.
Dosing: Renal 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.
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)
* See Uses in AHFS Essentials for additional information.
Administration: Topical
For external use only; avoid contact with eyes, mouth, nose, or other mucous membranes. Apply to clean, dry skin. Avoid occlusive dressings.
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.
Storage/Stability
Lotrimin Ultra: Store at 20° to 25°C (68° to 77°F).
Mentax: Store at 5°C to 30°C (41°F to 86°F).
Medication Patient Education with HCAHPS Considerations
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Have patient report immediately to prescriber skin irritation, burning, redness, edema, skin sores, blisters, oozing, or bleeding (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
Medication Safety Issues
Sound-alike/look-alike issues:
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.
* See Cautions in AHFS Essentials for additional information.
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse effects were not observed in animal reproduction studies.
Breast-Feeding 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.
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
≥1%: Dermatologic: Burning sensation of skin, contact dermatitis, erythema, pruritus, skin irritation, stinging of the skin
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
There are no known significant interactions.
Monitoring Parameters
Culture and KOH exam, clinical signs of tinea pedis
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% (30 g [DSC]) [contains benzyl alcohol, cetyl alcohol, propylene glycol, sodium benzoate]
Lotrimin Ultra: 1% (12 g, 30 g) [contains benzyl alcohol, cetyl alcohol, propylene glycol, sodium benzoate, trolamine (triethanolamine)]
Mentax: 1% (15 g, 30 g) [contains benzyl alcohol, sodium benzoate]
Generic: 1% (12 g, 30 g)
Anatomic Therapeutic Chemical (ATC) Classification
- D01AE23
Generic Available (US)
Yes
Pricing: US
Cream (Butenafine HCl External)
1% (per gram): $0.67
Cream (Lotrimin Ultra External)
1% (per gram): $0.71
Cream (Mentax External)
1% (per gram): $7.51
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.
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.
Pharmacodynamics/Kinetics
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
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
No significant effects or complications reported
Effects on Bleeding
No information available to require special precautions
Index Terms
Butenafine Hydrochloride
FDA Approval Date
October 18, 1996
References
Greer DL, Weiss J, Rodriguez DA, et al, “A Randomized Trial to Assess Once-Daily Topical Treatment of Tinea Corporis With Butenafine, a New Antifungal Agent,” J Am Acad Dermatol, 1997, 37(2 Pt 1):231-5. [PubMed 9270509]
Lotrimin Ultra Antifungal (butenafine hydrochloride cream) [prescribing information]. Whitehouse Station, NJ: Merck; August 2013.
McNeely W and Spencer CM, “Butenafine,” Drugs, 1998, 55(3):405-12. [PubMed 9530545]
Mentax (butenafine hydrochloride cream) [prescribing information]. Morgantown, WV: Mylan; November 2013.
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]
Syed TA, Ahmadpour OA, Ahmad SA, et al, “Management of Toenail Onychomycosis With 2% Butenafine and 20% Urea Cream: A Placebo-Controlled, Double-Blind Study,” J Dermatol, 1998, 25(10):648-52. [PubMed 9830263]
“Topical Butenafine for Tinea Pedis,” Med Lett Drugs Ther, 1997, 39(1004):63-64.[PubMed 9217695]
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]
Brand Names: International
Ankorme (TW); Bunafine (TW); Butaximark (EG); Butefin (BD, TW); Butena (KR); Butop (IN); Derfina (SA); Dermacom (CL); Ennafine (KR); Farbicure (EG); Fintop (BD, VN); Funcid (PH); Lexoderil (CR, DO, GT, HN, NI, PA, SV); Mentax (BB, EE, IL, JO, JP, KR, TW); Mycovrex (EG); Napins (KR); Sanmasu (TW); Sergen (TW); Te Li Da (CN); Tenafin (BD); Tinearest (EG); Zaxem (AT)
Last Updated 11/6/19
Google Sites
Report abuse