Get your patient on Oxistat (Oxiconazole Nitrate)
Oxistat patient education
Patient toolkit
Dosage & administration
Oxistat prescribing information
INDICATIONS AND USAGE
OXISTAT Lotion is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ).
DOSAGE AND ADMINISTRATION
OXISTAT Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Tinea corporis and tinea cruris should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be reviewed.
CONTRAINDICATIONS
OXISTAT Lotion is contraindicated in individuals who have shown hypersensitivity to any of their components.
ADVERSE REACTIONS
In a controlled, multicenter clinical trial of 269 patients treated with oxiconazole nitrate lotion , 1%, 7 (2.6%) reported adverse reactions thought to be related to drug therapy. These reactions included burning and stinging (0.7% each) and pruritus, scaling, tingling, pain, and dyshidrotic eczema (0.4% each).
The following additional adverse experiences have been reported with the topical use of oxiconazole nitrate: irritation and allergic contact dermatitis, folliculitis, erythema, papules, fissure, maceration, rash, and nodules.
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-800-308-6755 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Potential drug interactions between OXISTAT and other drugs have not been systematically evaluated.
DESCRIPTION
OXISTAT ® (oxiconazole nitrate) Lotion, 1% contains the antifungal active compound oxiconazole nitrate. This formulation is for topical dermatologic use only.
Chemically, oxiconazole nitrate is 2',4'-dichloro-2-imidazol-1-ylacetophenone ( Z )-[ 0 -(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula C 18 H 13 ON 3 Cl 4 ·HNO 3 , a molecular weight of 492.15, and the following structural formula:
Oxiconazole nitrate is a nearly white crystalline powder, soluble in methanol; sparingly soluble in ethanol, chloroform, and acetone; and very slightly soluble in water.
OXISTAT Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water, white petrolatum, stearyl alcohol, propylene glycol, polysorbate 60, cetyl alcohol, and benzoic acid 0.2% as a preservative.
CLINICAL PHARMACOLOGY
Pharmacokinetics
The penetration of oxiconazole nitrate into different layers of the skin was assessed using an in vitro permeation technique with human skin. Five hours after application of 2.5 mg/cm 2 of oxiconazole nitrate cream onto human skin, the concentration of oxiconazole nitrate was demonstrated to be 16.2 μmol in the epidermis, 3.64 μmol in the upper corium, and 1.29 μmol in the deeper corium. Systemic absorption of oxiconazole nitrate is low. Using radiolabeled drug, less than 0.3% of the applied dose of oxiconazole nitrate was recovered in the urine of volunteer subjects up to 5 days after application of the cream formulation.
Neither in vitro nor in vivo studies have been conducted to establish relative activity between the lotion and cream formulations.
Microbiology
Oxiconazole nitrate is an imidazole derivative whose antifungal activity is derived primarily from the inhibition of ergosterol biosynthesis, which is critical for cellular membrane integrity. It has in vitro activity against a wide range of pathogenic fungi.
Oxiconazole has been shown to be active against most strains of the following organisms both in vitro and in clinical infections at indicated body sites (see INDICATIONS AND USAGE ):
Epidermophyton floccosum Trichophyton mentagrophytes Trichophyton rubrum Malassezia furfur
The following in vitro data are available; however, their clinical significance is unknown. Oxiconazole exhibits satisfactory in vitro minimum inhibitory concentrations (MICs) against most strains of the following organisms; however, the safety and efficacy of oxiconazole in treating clinical infections due to these organisms have not been established in adequate and well-controlled clinical trials:
Candida albicans Microsporum audouini Microsporum canis Microsporum gypseum Trichophyton tonsurans Trichophyton violaceum
CLINICAL STUDIES
The following definitions were applied to the clinical and microbiological outcomes in patients enrolled in the clinical trial that form the basis for the approval of OXISTAT Lotion.
Definitions
- Mycological Cure: No evidence (culture and KOH preparation) of the baseline (original) pathogen in a specimen from the affected area taken at the 2-week post-treatment visit (for tinea [pityriasis] versicolor, mycological cure was limited to KOH only).
- Treatment Success: Both a global evaluation of 90% clinical improvement and a microbiologic eradication (see above) at the 2-week post-treatment visit.
Tinea Pedis
The clinical trial for the lotion formulation line extension involved 332 evaluable patients with clinically and microbiologically established tinea pedis. Of these evaluable patients, 64% were diagnosed with hyperkeratotic plantar tinea pedis and 28% with interdigital tinea pedis. Seventy-seven percent (77%) had disease secondary to infection with Trichophyton rubrum, 18% had disease secondary to infection with Trichophyton mentagrophytes , and 4% had disease secondary to infection with Epidermophyton floccosum.
The results of this clinical trial at the 2-week post-treatment follow-up visit are shown in the following table:
| Patient Outcome | OXISTAT Lotion | Vehicle | |
|---|---|---|---|
| b.i.d. | q.d. | ||
Mycological cure | 67% | 64% | 28% |
Treatment success | 41% | 34% | 10% |
In this study, the improvement and cure rates of the b.i.d.- and q.d.-treated groups did not differ significantly (95% confidence interval) from each other but were statistically (95% confidence interval) superior to the vehicle-treated group.
HOW SUPPLIED
OXISTAT ® (oxiconazole nitrate) Lotion, 1% is supplied in: 30-mL bottle (NDC 62559-285-30) 60-mL bottle (NDC 62559-285-60)
Store at 20° to 25°C (68° to 77°F); excursions permitted at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Shake well before using.
OXISTAT is a registered trademark of Fougera Pharmaceuticals, Inc. and is licensed to ANI Pharmaceuticals, Inc.
Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 
N7000 Rev 05/22
