Oxistat

Topical Dermatological Antifungals

Wash hands before and after use. Use universal precautions (i.e., gloves) for application if needed.
Cleanse the affected area and dry thoroughly prior to application.

Oxiconazole lotion and cream are for topical external use and are not intended for ophthalmic or intravaginal administration. Avoid contact with eyes, nose, mouth, and other mucous membranes.
Shake the lotion well before using.
Apply oxiconazole cream or lotion sparingly in a thin film and rub gently into the cleansed, affected area.
For hairy areas use oxiconazole lotion. Part hair and apply small amount to the affected area and rub in gently. Until the medication has dried, protect from washing, clothing, or rubbing. Hair may be washed as usual but not immediately after applying the medication.

contact dermatitis / Delayed / 0.4-0.4
erythema / Early / 0.2-0.2

pruritus / Rapid / 1.6-1.6
skin irritation / Early / 0.7-1.4
folliculitis / Delayed / 0.3-0.3
rash / Early / 0.1-0.1

Oxistat

Rx

Topical imidazole antifungal agent
Available as both a cream and lotion
Active against a variety of organisms responsible for causing tinea pedis, tinea corporis, and tinea cruri; the cream is also indicated for tinea versicolor

Apply to the affected area(s) and the immediately surrounding area(s) 1—2 times per day. Tinea corporis and tinea cruris should be treated for 2 weeks; tinea pedis should be treated 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.

Apply to the affected area(s) and the immediately surrounding area(s) once daily for 2 weeks. Treatment of the infection may not immediately result in restoration of pigment to affected areas. Normalization of pigmentation following successful therapy is variable and may take months depending upon skin type and sun exposure.

No dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Nystatin: (Moderate) The combination of oxiconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.

Oxiconazole Nitrate/Oxistat Topical Cream: 1%
Oxiconazole Nitrate/Oxistat Topical Lotion: 1%

2 applications/day.

2 applications/day.

2 applications/day.

2 applications/day.

Mechanism of Action: Oxiconazole is an imidazole antifungal derivative whose antifungal activity occurs secondary to inhibition of ergosterol biosynthesis. Ergosterol is a critical component of cellular membrane integrity. Oxiconazole inhibits 14-alpha-demethylase, which impairs the biosynthesis of ergosterol, which is important for the fungal cytoplasmic membrane. Oxiconazole and other azole antifungal agents may directly increase fungal cytoplasmic membrane permeability through the high concentrations that are achieved with topical application. Oxiconazole is clinically active against a wide variety of pathogen fungi including Epidermophyton floccosum, Trichophyton mentagrophytes, Trichophyton rubrum, and Malassezia furfur.

Oxiconazole is applied topically.

There is little systemic absorption following topical application; however, percutaneous absorption is dependent on many factors including the vehicle, integrity of the epidermal barrier, use of occlusive dressings, and location of drug administration on the body. Inflammation and other disease processes of the skin may also increase absorption of oxiconazole. After 5 hours, the concentration of oxiconazole 2.5 mg/cm2 in the epidermis was 16.2 µmol, 3.64 µmol in the upper corium, and 1.29 µmol in the deeper corium. Less than 0.3% of the applied dose of oxiconazole cream was recovered in the urine of healthy volunteers up to 5 days after application. There have been no in vitro or in vivo studies conducted to determine the relative activity of the lotion and cream formulations.

Oxiconazole is classified as FDA pregnancy risk category B. Adequate studies in pregnant women have not been conducted. Reproductive studies performed in rats, rabbits, and mice utilizing oral doses that were up to 57 times greater than the human dose revealed no fetal harm. Animal reproductive studies are not necessarily representative of human results, so oxiconazole should only be used during pregnancy if it is clearly indicated.

Oxiconazole is excreted in breast milk and should be used with caution during breast-feeding. However, because topically applied oxiconazole is poorly absorbed, the exposure risk of a breast-feeding infant is low. Instruct mothers not to apply oxiconazole topically to the breast while breast-feeding. Clotrimazole and miconazole may be potential alternatives to consider during breast-feeding. However, site of infection, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.