OXISTAT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OXISTAT (OXISTAT).
Oxiconazole is an azole antifungal that inhibits fungal cytochrome P450 14α-demethylase, blocking ergosterol synthesis and disrupting fungal cell membrane integrity.
| Metabolism | Following topical application, minimal systemic absorption occurs; any absorbed drug is metabolized in the liver via oxidation and glucuronidation. |
| Excretion | Primarily hepatic metabolism; <1% excreted unchanged in urine; biliary/fecal elimination accounts for ~75% of dose. |
| Half-life | Terminal elimination half-life is 20–30 hours, supporting once-daily topical application. |
| Protein binding | >98% bound to plasma proteins (albumin and α1-acid glycoprotein). |
| Volume of Distribution | Vd ~200 L/kg (very large, indicating extensive tissue binding and distribution). |
| Bioavailability | Topical: negligible systemic absorption (<1% of applied dose). |
| Onset of Action | Topical: clinical improvement noted within 1–2 weeks of twice-daily application. |
| Duration of Action | Duration of action after topical application is 24 hours, allowing once-daily dosing. |
Apply topically once daily for 2 weeks (tinea pedis, tinea cruris, tinea corporis) or 4 weeks (tinea versicolor).
| Dosage form | CREAM |
| Renal impairment | No dose adjustment required. |
| Liver impairment | No dose adjustment required. |
| Pediatric use | Safety and efficacy in pediatric patients below 2 years have not been established. For children 2 years and older, same as adult dosing. |
| Geriatric use | No specific dose adjustment recommended; use same as adult dosing. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OXISTAT (OXISTAT).
| Breastfeeding | Unknown if excreted in human milk; M/P ratio not available. Caution advised. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; insufficient human data. Risk cannot be excluded; use only if clearly needed. |
| Fetal Monitoring | No specific maternal-fetal monitoring required; monitor for local adverse effects. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to oxiconazole or any component of the formulation"]
| Precautions | ["For topical use only; not for ophthalmic, oral, or intravaginal use","May cause local irritation, pruritus, or contact dermatitis","Discontinue if sensitivity or irritation develops","Avoid occlusive dressings unless directed by physician"] |
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| Fertility Effects | No known effect on fertility in animal studies; no human data. |