Sertaconazole Use in Pediatric Patients
Sertaconazole is safe and appropriate for topical use in children aged 5 years for superficial fungal skin infections, but it should never be used systemically, and there is no established role for this agent in invasive or systemic fungal infections in pediatric patients.
Topical Sertaconazole for Superficial Mycoses
- Sertaconazole 2% cream applied twice daily is effective for treating superficial skin mycoses including tinea corporis, tinea cruris, tinea pedis, and cutaneous candidiasis in pediatric patients 1
- The drug demonstrates broad-spectrum antifungal activity against dermatophytes (Trichophyton, Epidermophyton, Microsporum genera) and Candida species with minimal systemic absorption when applied topically 1
- Clinical trials showed significantly higher mycological cure rates (65-100%) compared to placebo and miconazole for dermatophytoses, with good tolerability and primarily mild cutaneous adverse events (contact dermatitis, burning, pruritus) 1
Critical Distinction: Topical vs. Systemic Use
- Plasma levels of sertaconazole remain undetectable following topical application, confirming the absence of systemic absorption 1
- For any suspected invasive or systemic fungal infection in a 5-year-old, sertaconazole has no role—fluconazole 8-12 mg/kg once daily is the first-line systemic agent for invasive candidiasis 2
- If mold-active coverage is required, voriconazole 9 mg/kg twice daily (for ages 2-14 years) or itraconazole suspension 2.5 mg/kg twice daily (for patients ≥2 years) should be used with therapeutic drug monitoring 2
Clinical Decision Algorithm for Fungal Infections in 5-Year-Olds
For Superficial Skin Infections:
- Tinea corporis/cruris/pedis or cutaneous candidiasis → Apply sertaconazole 2% cream twice daily for 3-6 weeks until complete clinical resolution 1
- Alternative topical agents include clotrimazole or miconazole if sertaconazole is unavailable 3
For Invasive or Systemic Infections:
- Invasive candidiasis → Fluconazole 8-12 mg/kg IV or orally once daily 2
- Suspected aspergillosis or mold infection → Voriconazole 9 mg/kg BID with TDM (target trough ≥1 mg/L) 2
- Immunocompromised patients (HSCT, leukemia) → Consider micafungin 1 mg/kg IV daily or itraconazole 2.5 mg/kg twice daily with TDM (target trough ≥0.5 mg/L) 2
Important Caveats
- Sertaconazole maintains antifungal activity against dermatophyte isolates with reduced susceptibility to other azoles (fluconazole MICs ≥16 mcg/mL), making it valuable for azole-resistant superficial infections 1
- Only 4% of clinical dermatophyte isolates show resistance to sertaconazole, and continuous culture fails to induce resistance 1
- Never use systemic ketoconazole in pediatric patients due to FDA/EMA warnings regarding hepatotoxicity, adrenal suppression, and drug interactions—this principle extends to avoiding systemic use of any topical-only azole 4
- For vaginal candidiasis in prepubertal children, topical nystatin or azole creams remain first-line, not sertaconazole suppositories which are designed for postpubertal patients 3