Butenafine Hydrochloride

• Approved Indications:
• Treatment of superficial fungal infections including:
• Tinea corporis (ringworm of the body)
• Tinea cruris (jock itch)
• Tinea pedis (athlete’s foot)
• Pityriasis versicolor caused by Malassezia species
• Cutaneous candidiasis
• Off-label Uses:
• Occasionally used for other superficial fungal infections as determined by clinical judgment.

• Adults and Adolescents (≥12 years):
• Apply a thin layer of cream or gel to the affected area once daily.
• Duration:
• 2 weeks for tinea versicolor
• 4 weeks for tinea pedis, tinea cruris, and tinea corporis
• Pediatrics (<12 years):
• Use not well established; consult a physician.
• Elderly:
• No specific dosage adjustment required.
• Special Populations:
• No dose adjustment needed for renal or hepatic impairment.
• Administration Instructions:
• Clean and dry the area before application.
• Avoid occlusive dressings unless prescribed.
• Wash hands after applying.

Butenafine hydrochloride is a benzylamine antifungal agent that inhibits the enzyme squalene epoxidase, a key step in ergosterol biosynthesis within fungal cell membranes. This leads to toxic accumulation of squalene and depletion of ergosterol, disrupting fungal cell membrane integrity and resulting in fungal cell death.

• Absorption: Minimal systemic absorption after topical application.
• Distribution: Concentrates mainly in the stratum corneum.
• Metabolism: Minimal systemic metabolism due to low absorption.
• Half-life: Not clinically relevant due to topical use.
• Excretion: Negligible systemic excretion.

• Pregnancy: Category B (no evidence of risk in animal studies; insufficient human data). Use only if clearly needed.
• Lactation: Unknown if excreted in human milk; caution advised during breastfeeding.

• Primary Class: Antifungal
• Subclass: Benzylamine derivative, topical antifungal

• Hypersensitivity to butenafine hydrochloride or formulation excipients.
• Use on mucous membranes, eyes, or broken skin is contraindicated.

• Avoid contact with eyes and mucous membranes.
• Discontinue if irritation or hypersensitivity occurs.
• Use caution in patients with extensive skin lesions.
• Not for systemic fungal infections.

• Common: Local burning, itching, redness, dryness.
• Uncommon: Allergic contact dermatitis, rash.
• Rare: Severe hypersensitivity reactions.

• No significant systemic drug interactions reported.
• Use caution when combining with other topical agents.

• Recognized as an effective topical antifungal agent.
• No recent changes in dosing or safety warnings.

• Store at 20°C to 25°C (room temperature).
• Protect from heat and moisture.
• Keep tube tightly closed.
• Keep out of reach of children.