Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Oxistat: 1% (30 g, 60 g, 90 g) [contains benzoic acid, cetyl alcohol, propylene glycol]
Generic: 1% (30 g, 60 g, 90 g)
Lotion, External:
Oxistat: 1% (30 mL, 60 mL) [contains benzoic acid, cetyl alcohol, propylene glycol]
Pharmacology
Mechanism of Action
The cytoplasmic membrane integrity of fungi is destroyed by oxiconazole which exerts a fungicidal activity through inhibition of ergosterol synthesis. Effective for treatment of tinea pedis, tinea cruris, tinea corporis, and tinea versicolor. Active against Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton violaceum, Microsporum canis, Microsporum audouinii, Microsporum gypseum, Epidermophyton floccosum, Candida albicans, and Malassezia furfur.
Pharmacokinetics/Pharmacodynamics
Absorption
In each layer of the dermis; very little systemically after one topical dose
Distribution
To each layer of the dermis
Excretion
Urine (<0.3%)
Use: Labeled Indications
Cream: Topical treatment of tinea pedis (athlete's foot); tinea cruris (jock itch); tinea corporis (ringworm) due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum; and tinea (pityriasis) versicolor due to Malassezia furfur
Lotion: Treatment of tinea pedis (athlete's foot); tinea cruris (jock itch); tinea corporis (ringworm) due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
Contraindications
Hypersensitivity to oxiconazole or any component of the formulation
Dosage and Administration
Dosing: Adult
Tinea corporis/tinea cruris: Topical: Cream, lotion: Apply to affected areas 1 to 2 times daily for 2 weeks
Tinea pedis: Topical: Cream, lotion: Apply to affected areas 1 to 2 times daily for 1 month
Tinea versicolor: Topical: Cream: Apply to affected areas once daily for 2 weeks
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Tinea corporis, tinea cruris, tinea pedis, tinea versicolor: Children ≥12 years and Adolescents: Topical: Cream: Refer to adult dosing.
Administration
For external use only; avoid contact with eyes, nose, mouth, or other mucous membranes. Avoid occlusive dressings. Wash hands before and after use.
Storage
Store between 15°C to 30°C (59°F to 86°F). Shake lotion well before use.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
1% to 10%:
Central nervous system: Localized burning (≤1%)
Dermatologic: Pruritus (<2%)
<1%, postmarketing, and/or case reports: Allergic contact dermatitis, dyshidrotic eczema, erythema, exfoliation of skin, folliculitis, maceration of the skin, nodule, pain, papule, skin fissure, skin irritation, skin rash, stinging of the skin, tingling of skin
Warnings/Precautions
Concerns related to adverse effects:
- Irritation: Discontinue if sensitivity or irritation occurs
Other warnings/precautions:
- Appropriate use: For topical use only; not for ophthalmologic, oral, or vaginal use.
Pregnancy
Pregnancy Risk Factor
B
Pregnancy Considerations
When administered orally, teratogenic effects were not observed in animal reproduction studies.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber severe application site irritation, blistering, edema, burning, oozing, or bleeding (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
