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Butenafine

Pronunciation

(byoo TEN a feen)

Index Terms

  • Butenafine Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, External, as hydrochloride:

Lotrimin Ultra: 1% (30 g) [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]

Brand Names: U.S.

  • Lotrimin Ultra [OTC]
  • Mentax

Pharmacologic Category

  • Antifungal Agent, Topical

Pharmacology

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.

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

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.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

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 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?)

• Patient may experience burning, itching, redness, or stinging. Have patient report immediately to prescriber severe skin irritation, 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.

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