ERTACZO
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ERTACZO (ERTACZO).
Sertaconazole (the active ingredient in ERTACZO) inhibits fungal cytochrome P450 14α-demethylase, blocking ergosterol synthesis and disrupting fungal cell membrane integrity.
| Metabolism | Minimal percutaneous absorption; systemically absorbed drug is extensively metabolized in the liver via oxidation and glucuronidation. |
| Excretion | Primarily fecal (approximately 80% of administered dose recovered in feces as unchanged drug and metabolites) and renal (about 10%, predominantly as metabolites). |
| Half-life | Terminal elimination half-life is approximately 30 hours, supporting once-daily topical application. |
| Protein binding | Approximately 99% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Not determined (Vd not applicable for topical drug; systemic absorption minimal). |
| Bioavailability | Systemic bioavailability approximately <1% after topical application to intact skin. |
| Onset of Action | Clinical improvement observed within 1-2 weeks of once-daily application; full therapeutic effect may require 4-6 weeks of treatment. |
| Duration of Action | Sustained antifungal effect at application site for 24 hours, supporting once-daily dosing. |
Apply a thin layer to the affected area once daily for 4 weeks.
| Dosage form | CREAM |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No dosage adjustment required for hepatic impairment. |
| Pediatric use | Safety and efficacy in pediatric patients below 12 years have not been established. |
| Geriatric use | No specific dosage adjustment recommended; use with caution due to potential age-related skin changes. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ERTACZO (ERTACZO).
| Breastfeeding | It is not known whether sertaconazole is excreted in human milk after topical application. Because many drugs are excreted in milk, caution is advised. M/P ratio: Not available. Given minimal systemic absorption, significant infant exposure is unlikely. Consider risk-benefit. |
| Teratogenic Risk | Pregnancy Category C. In animal studies, sertaconazole (the active ingredient) showed no teratogenic effects at doses up to 5 times the human topical dose. However, no adequate and well-controlled studies in pregnant women exist. Risk cannot be ruled out; use only if clearly needed. First trimester: Unknown risk. Second and third trimesters: Limited data, but systemic absorption is minimal, so risk likely low. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Known hypersensitivity to sertaconazole or any ingredient in the formulation"]
| Precautions | ["For external use only","Avoid contact with eyes","Discontinue if irritation or sensitization occurs","Not for ophthalmic, oral, or intravaginal use"] |
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| Fetal Monitoring | No specific maternal or fetal monitoring required for topical use due to negligible systemic absorption. Monitor for local skin irritation or allergic contact dermatitis. |
| Fertility Effects | No studies on fertility effects have been conducted. Systemic absorption is minimal; thus, significant impact on fertility is unlikely. |