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. |
| Molecular Weight | 492.17 |
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 | No controlled data in human pregnancy; animal studies show no embryotoxicity at topical doses. Use only if potential benefit justifies risk. |
| 2nd trimester | Systemic absorption minimal with topical application; no known fetal risk. Consider alternative antifungal if prolonged treatment needed. |
| 3rd trimester | As with t2, low risk due to negligible systemic absorption; avoid application to large areas or broken skin near term. |
Clinical note
Comprehensive clinical and safety monograph for OXISTAT (OXISTAT).
| Placental transfer | Placental transfer minimal due to low systemic absorption after topical application; peak plasma concentrations <5 ng/mL after topical dose. |
| Breastfeeding | Topical oxiconazole is minimally absorbed systemically. However, avoid application to breast or nipples to prevent infant ingestion. Use with caution in nursing mothers. |
■ 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 |
| Food/Dietary | None known for topical oxiconazole. No dietary restrictions. |
| Clinical Pearls | Oxistat (oxiconazole nitrate) is a topical antifungal for tinea infections. Apply once daily (evening) for 2 weeks (tinea pedis, tinea cruris, tinea corporis). Not for nail or scalp infections. Avoid occlusive dressings unless directed. For tinea pedis, treat interdigital spaces thoroughly. |
Loading safety data…
| Lactation Rating | L3 (Moderately Safe) |
| 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. |
| Fertility Effects | No known effect on fertility in animal studies; no human data. |
| Patient Advice | Apply a thin layer to affected skin once daily, preferably at bedtime. · Wash hands after application unless treating hands. · Continue use for full prescribed duration, even if symptoms improve. · Avoid contact with eyes, mouth, or open wounds. · Notify your doctor if no improvement after 2 weeks or if condition worsens. |