ECOZA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ECOZA (ECOZA).
Imidazole antifungal inhibiting ergosterol synthesis via CYP51, disrupting fungal cell membrane permeability.
| Metabolism | Not extensively metabolized; minimal systemic absorption after topical application. |
| Excretion | Primarily hepatic metabolism; <1% excreted renally as unchanged drug. Fecal excretion accounts for ~57% of metabolites. |
| Half-life | Terminal elimination half-life is approximately 24–30 hours, allowing for once-daily dosing. |
| Protein binding | Approximately 89–93% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Apparent volume of distribution is approximately 2–3 L/kg, indicating extensive tissue penetration. |
| Bioavailability | Oral bioavailability is approximately 37% (range 20–70%) due to first-pass metabolism; topical bioavailability is negligible systemically. |
| Onset of Action | Oral: Peak plasma concentrations reached within 1–5 hours; clinical antifungal effect evident within 24–48 hours. Topical: Onset of symptom relief within hours to days depending on formulation. |
| Duration of Action | Sustained therapeutic effect for 24 hours with oral dosing; topical formulations require repeated application (e.g., twice daily) for duration of treatment. |
| Molecular Weight | 381.68 |
For vulvovaginal candidiasis: One vaginal suppository (150 mg) inserted intravaginally at bedtime for 3 consecutive days. For cutaneous candidiasis: Apply cream (1%) to affected area twice daily for 2-4 weeks.
| Dosage form | AEROSOL, FOAM |
| Renal impairment | No dosage adjustment required for renal impairment. Systemic absorption is minimal after topical or intravaginal use. |
| Liver impairment | No dosage adjustment required for hepatic impairment due to minimal systemic absorption. |
| Pediatric use | Safety and efficacy in pediatric patients have not been established for vaginal use. For cutaneous candidiasis: Apply cream (1%) to affected area twice daily; duration based on clinical response. Weight-based dosing not applicable. |
| Geriatric use | No specific dose adjustment required; use same dosing as for younger adults. Monitor for local irritation or adverse effects. |
| 1st trimester | Contraindicated due to risk of fetal anomalies (azole antifungals associated with skeletal and visceral malformations in animal studies). |
| 2nd trimester | Avoid unless benefit outweighs risk; limited human data but potential fetal toxicity. |
| 3rd trimester | Avoid near term due to risk of neonatal hepatic toxicity and prolonged QT interval. |
Clinical note
Comprehensive clinical and safety monograph for ECOZA (ECOZA).
| Placental transfer | Crosses placenta; achieves fetal concentrations 50-100% of maternal plasma. |
| Breastfeeding | Excreted into breast milk; potential for infant hepatic toxicity and QT prolongation. Use caution, monitor infant for jaundice and arrhythmias. |
| Lactation Rating |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to azole antifungalsConcurrent administration with CYP3A4 substrates that prolong QT interval (e.g., cisapride, pimozide, quinidine)Severe hepatic impairment
| Precautions | For external use only; avoid contact with eyes; discontinue if hypersensitivity occurs. |
| Food/Dietary | No clinically significant food interactions for topical econazole nitrate. Avoid alcohol if using oral antifungal concurrently (not applicable here). |
| Clinical Pearls |
Loading safety data…
| L3 (Moderately Safe) |
| Teratogenic Risk | ECOZA (econazole nitrate) is pregnancy category C. First trimester: no adequate studies; avoid unless benefit outweighs risk. Second/third trimester: minimal absorption after topical application, unlikely to cause fetal harm; however, prolonged use near term is not recommended due to theoretical risk of premature ductus arteriosus closure if systemic absorption occurs. |
| Fetal Monitoring | No specific monitoring required. Monitor for local irritation or allergic reaction. If used near term, observe for signs of premature ductus arteriosus closure in neonate (rare). |
| Fertility Effects | No known effect on fertility. Animal studies showed no impairment. |
| Ecoza (econazole nitrate) is a topical azole antifungal. Avoid use on open wounds or broken skin. Apply once daily for 4 weeks for tinea pedis; 2 weeks for tinea cruris/corporis. Do not use occlusive dressings. Monitor for local irritation, burning, or allergic contact dermatitis. |
| Patient Advice | Apply a thin layer to cleaned, dry affected area and surrounding skin once daily or as directed. · Wash hands before and after application unless treating hands. · Use for the full prescribed duration even if symptoms improve to prevent recurrence. · Avoid contact with eyes, mouth, or mucous membranes. If contact occurs, rinse with water. · Do not cover the treated area with bandages or wrappings unless instructed by your doctor. · Inform your doctor if symptoms persist after 2 weeks or worsen, or if severe irritation occurs. · Store at room temperature away from moisture and heat. |