Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
BUTENAFINE HYDROCHLORIDE vs AUKELSO
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Inhibits squalene epoxidase, blocking ergosterol synthesis and disrupting fungal cell membrane integrity.
Selective inhibitor of the mammalian target of rapamycin (m TOR) kinase, specifically the m TORC1 complex, leading to inhibition of cell proliferation, angiogenesis, and glucose uptake.
Topical treatment of tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) due to Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.
Advanced renal cell carcinoma,Progressive neuroendocrine tumors of pancreatic origin,Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis,Advanced neuroendocrine tumors of gastrointestinal or lung origin
1% cream applied topically once daily for 2 weeks for tinea pedis, 1 week for tinea corporis/cruris.
400 mg orally twice daily with food.
Terminal elimination half-life is approximately 35–40 hours following topical application; long half-life supports once-daily dosing.
Terminal elimination half-life approximately 24 hours (range 20–28 h), supports once-daily dosing; prolonged in severe hepatic impairment.
Not significantly metabolized; undergoes minimal hepatic metabolism via CYP enzymes (unknown specific isoforms).
Primarily metabolized by CYP3A4
Primarily metabolized in the liver; minimal excretion of unchanged drug. Less than 5% of a topical dose is absorbed systemically; excreted in urine and feces as metabolites.
Primarily hepatic metabolism with biliary excretion; ~20% renal elimination of unchanged drug. Fecal excretion of metabolites accounts for ~65% of total clearance.
Approximately 60–70% bound to plasma proteins, predominantly albumin.
High protein binding, approximately 99.8%, primarily to albumin and alpha-1-acid glycoprotein.
Not well characterized due to minimal systemic absorption; estimated volume of distribution is very low, consistent with extensive tissue binding or limited distribution.
Volume of distribution ~0.15 L/kg (range 0.12–0.18 L/kg), indicating limited extravascular distribution, predominantly confined to plasma and extracellular fluid.
Topical: Systemic bioavailability is less than 5% following topical administration; oral bioavailability has not been established as drug is not used systemically.
Oral bioavailability ~85%; unaffected by food.
No dose adjustment required; negligible systemic absorption.
GFR ≥60 m L/min: no adjustment; GFR 30-59 m L/min: 200 mg twice daily; GFR <30 m L/min: 200 mg once daily; hemodialysis: 200 mg three times weekly after dialysis.
No dose adjustment required; negligible systemic absorption.
Child-Pugh A: no adjustment; Child-Pugh B: 200 mg twice daily; Child-Pugh C: 200 mg once daily.
≥12 years: same as adult; <12 years: safety and efficacy not established; use only if clearly needed.
Body weight 10-20 kg: 200 mg twice daily; 20-40 kg: 300 mg twice daily; ≥40 kg: 400 mg twice daily.
No specific adjustment; same as adult dosing; monitor for skin irritation.
No specific dose adjustment based on age alone; monitor renal function and adjust per renal guidelines.
None.
No FDA black box warning.
For external use only.,Avoid contact with eyes, nose, mouth, and other mucous membranes.,Discontinue if irritation or sensitization occurs.,Not recommended for treatment of onychomycosis or scalp infections.
Non-infectious pneumonitis,Infections (including opportunistic infections),Hypersensitivity reactions,Renal impairment,Metabolic effects (hyperglycemia, hyperlipidemia),Interstitial lung disease,Hemorrhagic events,Wound healing complications,Immunosuppression,Increased risk of thrombosis
Hypersensitivity to butenafine hydrochloride or any components of the formulation.
Hypersensitivity to everolimus or any component of the formulation
No clinically significant food interactions reported. Butenafine is applied topically and systemic absorption is minimal, so dietary restrictions are not required.
Avoid grapefruit and grapefruit juice; may increase drug levels. Take with or without food, but high-fat meals may increase absorption. Avoid alcohol due to hepatotoxicity risk.
FDA Pregnancy Category B. No evidence of teratogenicity in animal studies; inadequate human data. Risk cannot be ruled out; avoid use in first trimester unless clearly needed.
First trimester: Avoid use due to potential for fetal harm based on animal studies showing developmental toxicity (including cardiovascular and skeletal malformations). Second and third trimesters: Use only if maternal benefit outweighs fetal risk; may cause fetal growth restriction or oligohydramnios in off-label experience. No adequate human data.
Unknown if excreted in human milk; M/P ratio not established. Use with caution in nursing mothers; consider benefits vs risks.
No human data on milk excretion or infant effects. M/P ratio unknown. Due to potential for serious adverse reactions (e.g., immunosuppression), advise against breastfeeding during treatment and for 2 weeks after last dose.
No dose adjustment required based on pharmacokinetic changes in pregnancy; topical application has minimal systemic absorption.
No established dose adjustment in pregnancy. Consider reduced dosing if increased clearance occurs (second trimester). Monitor drug levels if available; otherwise, adjust based on clinical response and toxicity.
Butenafine hydrochloride is a benzylamine antifungal with fungicidal activity against dermatophytes (e.g., Trichophyton rubrum, T. mentagrophytes, Epidermophyton floccosum) and yeasts (Malassezia spp.). It inhibits squalene epoxidase, leading to accumulation of squalene and disruption of fungal cell membrane synthesis. Applied once or twice daily for 1–4 weeks depending on indication. For tinea pedis (athlete's foot), treatment should extend 1 week beyond resolution to prevent recurrence. Avoid occlusion unless directed; may increase irritation. Contraindicated in hypersensitivity to any component. For severe or resistant cases, consider combination with keratolytics (e.g., salicylic acid) to enhance penetration.
Monitor for QT prolongation, electrolyte abnormalities, and hepatotoxicity. Adjust dose in renal impairment (Cr Cl <30 m L/min). Avoid use with strong CYP3A4 inhibitors or inducers. Note potential for phototoxicity; advise sun avoidance.
Apply butenafine cream exactly as prescribed: clean and dry the affected area before application.,Use enough medication to cover the affected skin and a small margin of healthy surrounding skin.,Wash your hands after applying, unless treating the hands.,Do not cover the treated area with bandages or dressings unless instructed by your doctor.,Complete the full course of treatment even if symptoms improve, to prevent recurrence.,Notify your doctor if no improvement after 2–4 weeks or if irritation, redness, or blistering occurs.,Avoid contact with eyes, mouth, nose, or broken skin; if accidental contact occurs, rinse with water.,Do not use for conditions other than those prescribed; butenafine is for external use only.
Take exactly as prescribed; do not change dose or stop without consulting doctor.,Avoid grapefruit and grapefruit juice during treatment.,Use effective contraception during therapy and for 1 month after last dose.,Report symptoms like irregular heartbeat, fainting, severe nausea/vomiting, or yellowing of skin/eyes immediately.,Use sunscreen and protective clothing; avoid sun exposure, even through glass.
"Etravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is primarily metabolized by CYP3A4 and CYP2C19. Butenafine, an antifungal agent, is also metabolized by CYP3A4. Concurrent use may inhibit the metabolism of butenafine, leading to increased systemic exposure and potential toxicity, including hepatotoxicity or QT prolongation."
"Ranolazine, an antianginal agent, inhibits CYP3A4 and CYP2D6, reducing the metabolism of Butenafine, an antifungal agent typically metabolized by these enzymes. This results in significantly elevated Butenafine serum concentrations, increasing the risk of systemic adverse effects such as hepatotoxicity and QT prolongation. Co-administration may lead to enhanced antifungal efficacy but also potential toxicity."
"Butenafine, an allylamine antifungal, inhibits squalene epoxidase, a key enzyme in ergosterol biosynthesis, leading to fungal cell death. Bepridil, a calcium channel blocker with class I antiarrhythmic properties, prolongs the QT interval by blocking cardiac potassium channels, increasing the risk of torsades de pointes. When combined, butenafine may further inhibit hERG potassium channels in cardiac myocytes, potentiating QT prolongation and elevating the risk of life-threatening ventricular arrhythmias, particularly in patients with preexisting QT prolongation or electrolyte abnormalities."
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about BUTENAFINE HYDROCHLORIDE vs AUKELSO, answered by our medical review team.
BUTENAFINE HYDROCHLORIDE is a Antifungal that works by Inhibits squalene epoxidase, blocking ergosterol synthesis and disrupting fungal cell membrane integrity.. AUKELSO is a Topical Antifungal that works by Selective inhibitor of the mammalian target of rapamycin (m TOR) kinase, specifically the m TORC1 complex, leading to inhibition of cell proliferation, angiogenesis, and glucose uptake.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between BUTENAFINE HYDROCHLORIDE and AUKELSO depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of BUTENAFINE HYDROCHLORIDE is: 1% cream applied topically once daily for 2 weeks for tinea pedis, 1 week for tinea corporis/cruris.. The standard adult dose of AUKELSO is: 400 mg orally twice daily with food.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between BUTENAFINE HYDROCHLORIDE and AUKELSO in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. BUTENAFINE HYDROCHLORIDE is classified as Category C. FDA Pregnancy Category B. No evidence of teratogenicity in animal studies; inadequate human data. Risk cannot be ruled out; avoid use in first trimester unless clearly needed.. AUKELSO is classified as Category C. First trimester: Avoid use due to potential for fetal harm based on animal studies showing developmental toxicity (including cardiovascular and skeletal malformations). Second and . Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.