Oxiconazole (Topical)
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VA CLASSIFICATION
Primary: DE102
Commonly used brand name(s): Oxistat; Oxizole.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antifungal (topical)—
Indications
Accepted
Tinea corporis (treatment)1
Tinea cruris (treatment)1 or
Tinea pedis (treatment)—Oxiconazole is indicated in the topical treatment of tinea corporis (ringworm of the body), tinea cruris (ringworm of the groin; jock itch), and tinea pedis (ringworm of the foot; athlete"s foot) caused by Trichophyton rubrum , T. mentagrophytes , and Epidermophyton floccosum . {01} {03} {06} {07}{08}
Tinea (pityriasis) versicolor (treatment)1—Oxiconazole (cream only) is indicated in the topical treatment of tinea (pityriasis) versicolor (ringworm of the trunk) caused by Malassezia furfur.{01}{08}
1 Not included in Canadian product labeling.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
Oxiconazole nitrate: 492.15 {01}
Mechanism of action/Effect:
Inhibits ergosterol biosynthesis, which is necessary for fungal cellular membrane integrity. {01}
Absorption:
Low—Systemic absorption. {01} {07}
Elimination:
Less than 0.3% of a topically applied dose of oxiconazole cream (2.5 mg per square cm of body surface area) was recovered in the urine up to 5 days after application of the cream formulation. {01}
Precautions to Consider
Carcinogenicity
No studies have been done. {01}
Mutagenicity
No evidence of mutagenic effect was found in 2 mutation assays (Ames test and Chinese hamster V79 in vitro cell mutation assay) and in 2 cytogenetic assays (human peripheral blood lymphocyte in vitro chromosome aberration assay and in vivo micronucleus assay in mice). {01}
Pregnancy/Reproduction
Fertility—
Fertility was not impaired in female rats given oral doses of 3 mg per kg of body weight (mg/kg) a day and in male rats given 15 mg/kg a day. However, rats given higher oral doses than those listed above exhibited reduced sperm counts, extended estrous cycles, and decreased mating frequency. {01}
Pregnancy—
Adequate and well-controlled studies in humans have not been done.
Teratogenic studies in rabbits, rats, and mice given oral doses of 100, 150, and 200 mg/kg a day, respectively, have not shown that oxiconazole causes adverse effects on the fetus.
FDA Pregnancy Category B. {01}
Breast-feeding
Topical oxiconazole is distributed into breast milk. Problems in humans have not been documented.{01}
Pediatrics
Appropriate studies performed with oxiconazole cream to date have not demonstrated pediatric-specific problems that would limit the usefulness of oxiconazole cream in children. However, the indications for which oxiconazole cream has been shown to be effective rarely occur in children below the age of 12.{01}
Geriatrics
Appropriate studies on the relationship of age to the effects of topical oxiconazole have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Risk-benefit should be considered when the following medical problem exists
Sensitivity to oxiconazole {01}{04} {05}
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention
Incidence less frequent
Burning and pruritis{01}{08} (itching)—not present before use of this medicine
Incidence rare
Contact dermatitis, allergic{01}{08} (blistering, burning, crusting, dryness, or flaking of skin ; itching ; scaling; severe redness, soreness, or swelling of skin)
folliculitis{01}{08} (burning, itching, and pain in hairy areas; pus at root of hair), skin irritation{01}{08} —not present before use of this medicine
Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent or rare
Pain{01}{08}
skin rash{01}{08}
stinging{01}{08}
tingling{01}{08}
Overdose
For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing).
Clinical effects of overdose
Overdoses in humans have not been reported. An animal toxicology study demonstrated 3 deaths and severe dermal inflammation after 5% oxiconazole cream was applied at a rate of 1gram per kg of body weight over approximately 10% of the body surface area of rats for 35 days.{01}
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Oxiconazole (Topical).
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Sensitivity to oxiconazole
Breast-feeding—Distributed into breast milk
Proper use of this medication
Applying sufficient medication to cover affected and surrounding areas, and rubbing in gently
» Avoiding contact with the eyes, nose mouth, and other mucous membranes; not using in vagina
Wash hands after application to affected areas.
» Compliance with full course of therapy; fungal infections may require prolonged therapy
» Proper dosing
Missed dose: Applying as soon as possible; not applying if almost time for next dose
» Proper storage
Precautions while using this medication
Checking with physician if no improvement occurs within 2 to 4 weeks
» Using hygienic measures to cure infection and prevent reinfection:
For tinea cruris
Avoiding underwear that is tight-fitting or made from synthetic materials; wearing loose-fitting cotton underwear instead
Using a bland, absorbent powder or an antifungal powder on the skin; using the powder between administration times for oxiconazole
For tinea pedis
Carefully drying feet, especially between toes, after bathing
Avoiding socks made from wool or synthetic materials; wearing clean, cotton socks and changing them each day or more often if feet perspire excessively
Wearing sandals or well-ventilated shoes
Using bland, absorbent powder or an antifungal powder between toes, on feet, and in socks and shoes 1 or 2 times a day; using the powder between administration times for oxiconazole
Side/adverse effects
Signs of potential side effects, especially burning and pruritis, allergic contact dermatitis, folliculitis, and skin irritation.
General Dosing Information
To reduce the possibility of recurrence, tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for at least 2 weeks; tinea pedis should be treated for at least 4 weeks. {01}
Hypopigmented or hyperpigmented patches of the skin due to tinea versicolor may not readily resolve following successful therapy. Resolution may take months, depending on individual skin type and incidental sun exposure. Ringworm of the trunk (tinea versicolor) may recur because the causative organism is part of the normal skin flora{01}
Topical Dosage Forms
Note: The dosing and strength of the dosage forms available are expressed in terms of oxiconazole base. {01}
OXICONAZOLE NITRATE CREAM
Usual adult and adolescent dose
Tinea pedis
Tinea corporis1
Tinea cruris1
Topical , to the skin and surrounding areas, one to two times a day. {01} {02}{08}
Tinea (pityriasis) versicolor 1
Topical, to the skin and surrounding areas, once daily.{01}{08}
Usual pediatric dose
See Usual adult and adolescent dose .
Strength(s) usually available
U.S.—
1% (base) (Rx) [Oxistat{01}]
Canada—
1% (base) (OTC) [Oxizole]
Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. {01}
Auxiliary labeling:
• For external use only. {01}
• Continue medicine for full time of treatment. {01}
OXICONAZOLE NITRATE LOTION
Usual adult and adolescent dose
Tinea pedis
Tinea corporis1
Tinea cruris1
Topical, to the skin and surrounding areas, one to two times a day. {01}
Usual pediatric dose
See Usual adult and adolescent dose .
Strength(s) usually available
U.S.—
1% (base) (Rx) [Oxistat{01}]
Canada—
1% (base) (OTC) [Oxizole]
Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. {01}
Auxiliary labeling:
• Shake well
• For external use only. {01}
• Continue medicine for full time of treatment. {01}
Revised: 03/15/2000
References
- Product Information: Oxistat(R) oxiconazole nitrate cream 1% and lotion 1%. GlaxoWellcome, Research Triangle Park, NC (PI revised 1/99) reviewed 2/2000.
- Ellis CN, et al. A placebo-controlled evaluation of once-daily versus twice-daily oxiconazole nitrate (1%) cream in the treatment of tinea pedis. Curr Ther Res 1989 Aug 2; 46(2): 269-76.
- Fromtling RA. Overview of medically important antifungal azole derivatives. Clin Microbiol Rev 1988; 1(2): 187-217.
- Jelen G, Tennstedt D. Contact dermatitis from topical imidazole antifungals: 15 new cases. Contact Dermatitis 1989; 21(1): 6-11.
- Hausen BM, et al. Studies on the sensitizing capacity of imidazole derivatives. Am J Contact Dermatitis 1990; 1(1): 25-33.
- Cleary JD, et al. Imidazoles and triazoles in antifungal therapy. DICP Ann Pharmacother (USA) 1990; 24(2): 148-52.
- Jegasothy BV, Pakes GE. Oxiconazole nitrate: pharmacology, efficacy, and safety of a new imidazole antifungal agent. Clin Ther 1991 Jan-Feb; 13(1): 126-41.
- Product Information: Oxizole®, oxiconazole. Stiefel, Montreal, PQ, Canada. In: Krogh CME (ed): Compendium of Pharmaceuticals and Specialties, 34th ed. Canadian Pharmaceutical Association, Ottawa, Ontario, Canada, 1999:p.1328.
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