Dosage Forms
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)
Pharmacology
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/Pharmacodynamics
Absorption
Minimally systemic
Metabolism
Hepatic via hydroxylation
Time to Peak
Serum: 6 to 15 hours
Half-Life Elimination
Biphasic: Alpha: 35 hours; Beta: >150 hours
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)
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
Dosage and Administration
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
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Children ≥12 years and Adolescents: Refer to adult dosing.
Administration
Topical: For external use only; avoid contact with eyes, mouth, nose, or other mucous membranes. Apply to clean, dry skin. Avoid occlusive dressings.
Storage
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).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
≥1%: Dermatologic: Burning sensation of skin, contact dermatitis, erythema, pruritus, skin irritation, stinging of the skin
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.
Monitoring Parameters
Culture and KOH exam, clinical signs of tinea pedis
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse effects were not observed in animal reproduction studies.
Patient Education
- 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.
