Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
CICLOPIROX vs AUKELSO
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: July 2026 · OpiCalc Medical Review Team
Ciclopirox is a hydroxypyridone antifungal agent that chelates polyvalent metal cations (e.g., Fe3+, Al3+) inhibiting metal-dependent enzymes, thereby disrupting fungal cellular metabolic processes, including mitochondrial electron transport and energy production.
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, tinea cruris, tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis,Treatment of seborrheic dermatitis of the scalp,Treatment of cutaneous candidiasis (moniliasis) due to Candida albicans,Treatment of onychomycosis of fingernails and toenails due to Trichophyton rubrum,Off-label: Treatment of tinea versicolor, vaginal candidiasis, and superficial dermatophyte infections
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
Ciclopirox 8% nail lacquer: Apply to affected nails once daily for up to 48 weeks. Ciclopirox 1% cream or lotion: Apply to affected skin twice daily for 2-4 weeks. Ciclopirox 1% shampoo: Apply to wet hair, lather, leave for 3 minutes, rinse; use twice weekly for 4 weeks (for seborrheic dermatitis).
400 mg orally twice daily with food.
Terminal elimination half-life: 1.7-3.0 hours in healthy individuals; prolonged in hepatic impairment
Terminal elimination half-life approximately 24 hours (range 20–28 h), supports once-daily dosing; prolonged in severe hepatic impairment.
Minimal systemic absorption following topical application. The small absorbed fraction is primarily metabolized via glucuronidation and oxidation. Unchanged drug and metabolites are excreted renally and fecally. Specific hepatic enzymes involved are not well characterized.
Primarily metabolized by CYP3A4
Renal: approximately 70-80% of the absorbed dose as unchanged drug and glucuronide conjugates; biliary/fecal: ~20-30%
Primarily hepatic metabolism with biliary excretion; ~20% renal elimination of unchanged drug. Fecal excretion of metabolites accounts for ~65% of total clearance.
94-98% bound to plasma proteins, primarily albumin
High protein binding, approximately 99.8%, primarily to albumin and alpha-1-acid glycoprotein.
1.2-2.0 L/kg, indicating extensive tissue 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: minimal systemic absorption (<1-5% of applied dose); oral: not formulated for systemic use
Oral bioavailability ~85%; unaffected by food.
No specific dose adjustments are recommended; systemic absorption is minimal (<1.3%) with topical application. For oral use (not available in the US), no data for renal impairment.
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 adjustments needed for topical use due to negligible systemic absorption. No data for oral formulations.
Child-Pugh A: no adjustment; Child-Pugh B: 200 mg twice daily; Child-Pugh C: 200 mg once daily.
Ciclopirox 1% cream: Approved for children ≥10 years with tinea pedis or tinea corporis; apply twice daily for 2 weeks. Ciclopirox 8% nail lacquer: Not recommended in children <12 years. Ciclopirox 1% shampoo: Not established in children <16 years.
Body weight 10-20 kg: 200 mg twice daily; 20-40 kg: 300 mg twice daily; ≥40 kg: 400 mg twice daily.
No specific dose adjustments; topical use has minimal systemic absorption. Consider skin thinning and increased risk of irritation in elderly; use caution with prolonged application.
No specific dose adjustment based on age alone; monitor renal function and adjust per renal guidelines.
None currently listed in FDA labeling.
No FDA black box warning.
For external use only; avoid contact with eyes and mucous membranes,If irritation or sensitivity develops, discontinue treatment,Not for intravaginal or ophthalmic use,Use in diabetic patients may require additional monitoring for nail infections,Keep away from heat and open flame (ciclopirox solution contains alcohol)
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 ciclopirox or any component of the formulation
Hypersensitivity to everolimus or any component of the formulation
No significant food interactions have been reported with topical ciclopirox. For oral ciclopirox (not available in the US), food may affect absorption; consult prescribing information.
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.
Topical ciclopirox has minimal systemic absorption ( < 1.5%) and is generally considered low risk. Animal studies with high doses have shown fetal toxicity, but no teratogenicity in rats or rabbits. For topical use, there is no evidence of teratogenicity in humans. However, sufficient data are lacking for first trimester risk. The drug should be used during pregnancy only if clearly needed, with caution primarily in first trimester.
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.
It is unknown if ciclopirox is excreted in human milk. Due to low systemic absorption after topical application, the amount ingested by a nursing infant is likely negligible. Use with caution on small areas and avoid application to breast. M/P ratio not established.
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 pharmacokinetic changes requiring dose adjustment have been reported for topical ciclopirox. Systemic absorption is minimal and pregnancy-induced changes in skin permeability or clearance are not expected to alter systemic exposure significantly. Standard topical dosing (apply twice daily to affected areas) is appropriate.
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.
Apply topical ciclopirox once or twice daily, covering the lesion and a 1 cm margin of normal skin. For nail infections, file away loose nail material before applying lacquer. Avoid occlusive dressings unless directed. Treatment duration for tinea pedis is 2 weeks; for tinea corporis/cruris, 2-4 weeks. For onychomycosis, treatment may require 48 weeks or until nail replacement.
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.
Wash hands before and after applying the medication.,Apply a thin layer to the affected area and rub in gently.,Do not use on open wounds, or in eyes, mouth, or vagina.,For nail lacquer, apply daily over the entire nail plate and to the underside of the nail tip.,Avoid nail polish or artificial nails during treatment.,Complete the full course even if symptoms improve.,Notify your doctor if irritation or allergic reaction occurs.
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.
"Combining ciclopirox, an antifungal agent, with benidipine, a calcium channel blocker, may result in increased toxicity or reduced therapeutic efficacy. Benidipine is metabolized via CYP3A4; ciclopirox can inhibit CYP3A4, potentially raising benidipine plasma concentrations and causing hypotension, dizziness, or peripheral edema. Additionally, ciclopirox may have additive cardiodepressant effects, leading to bradycardia or worsening heart failure in susceptible patients."
"Co-administration of Ciclopirox and Eperisone may lead to additive antagonism of normal muscle tone and coordination due to concurrent central nervous system depression. Ciclopirox, primarily used for dermatological conditions, has noted sedative effects from systemic absorption, while Eperisone centrally acts as a muscle relaxant with sedative properties. The combined use can potentiate drowsiness, dizziness, and impaired psychomotor function, increasing the risk of falls and accidents."
"Losartan, an angiotensin II receptor blocker, and ciclopirox, a topical antifungal, are not expected to have a clinically significant pharmacokinetic interaction. Ciclopirox is minimally absorbed through the skin (<0.01% of applied dose) and undergoes hepatic glucuronidation and renal excretion. Losartan is metabolized primarily by CYP2C9 and CYP3A4 to its active metabolite. The baseline statement suggests a theoretical inhibition of ciclopirox metabolism by losartan, but given ciclopirox's negligible systemic exposure after topical use and different metabolic pathways, this interaction is unlikely to produce adverse clinical outcomes."
No interactions on record
Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.
Common clinical questions about CICLOPIROX vs AUKELSO, answered by our medical review team.
CICLOPIROX is a Antifungal that works by Ciclopirox is a hydroxypyridone antifungal agent that chelates polyvalent metal cations (e.g., Fe3+, Al3+) inhibiting metal-dependent enzymes, thereby disrupting fungal cellular metabolic processes, including mitochondrial electron transport and energy production.. 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 CICLOPIROX 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 CICLOPIROX is: Ciclopirox 8% nail lacquer: Apply to affected nails once daily for up to 48 weeks. Ciclopirox 1% cream or lotion: Apply to affected skin twice daily for 2-4 weeks. Ciclopirox 1% shampoo: Apply to wet hair, lather, leave for 3 minutes, rinse; use twice weekly for 4 weeks (for seborrheic dermatitis).. 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 CICLOPIROX 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. CICLOPIROX is classified as Category A/B. Topical ciclopirox has minimal systemic absorption ( < 1.5%) and is generally considered low risk. Animal studies with high doses have shown fetal toxicity, but no teratogenicity i. 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.