部份中文硝酸奥昔康唑处方资料（仅供参考）
药品名称
通用名：硝酸奥昔康唑 
用法用量 
药理作用 咪唑类抗真菌药。 
适应症
局部应用治疗皮肤真菌感染。用1%的霜剂、粉剂或溶液局部应用治疗皮肤念珠菌感染，皮癣菌病和花斑癣， 
不良反应
局部应用有灼烧感和痒感。孕妇和授乳期妇女应用本品时注意事项同氟康唑。

 
OXISTAT® (oxiconazole nitrate cream) Cream, 1%*
OXISTAT® (oxiconazole nitrate lotion) Lotion, 1%*
*Potency expressed as oxiconazole
RxOnly
FOR TOPICAL DERMATOLOGIC USE ONLY—
NOT FOR OPHTHALMIC OR INTRAVAGINAL USE
DESCRIPTION
OXISTAT® (oxiconazole nitrate cream) Cream, 1% and OXISTAT® (oxiconazole nitrate lotion) Lotion, 1% formulations contain the antifungal active compound oxiconazole nitrate. Both formulations are 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 C18H13ON3CI4·HNO3, 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® Cream contains 10 mg of oxiconazole per gram of cream in a white to off-white, opaque cream base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.
OXISTAT® Lotion contains 10 mg of oxiconazole per gram of lotion in a white to off-white, opaque lotion base of purified water USP, white petrolatum USP, stearyl alcohol NF, propylene glycol USP, polysorbate 60 NF, cetyl alcohol NF, and benzoic acid USP 0.2% as a preservative.
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
OXISTAT® Cream and Lotion are 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. OXISTAT® Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES).
OXISTAT® Cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which OXISTAT® Cream has been shown to be effective rarely occur in children below the age of 12.
CONTRAINDICATIONS
OXISTAT® Cream and Lotion are contraindicated in individuals who have shown hypersensitivity to any of their components.
WARNINGS
OXISTAT® (oxiconazole nitrate cream)Cream, 1% and OXISTAT® (oxiconazole nitrate lotion) Lotion, 1% are not for ophthalmic or intravaginal use.
PRECAUTIONS
ADVERSE REACTIONS
During clinical trials, of 955 patients treated with oxiconazole nitrate cream, 1%, 41 (4.3%) reported adverse reactions thought to be related to drug therapy. These reactions included pruritus (1.6%); burning (1.4%); irritation and allergic contact dermatitis (0.4% each); folliculitis (0.3%); erythema (0.2%); and papules, fissure, maceration, rash, stinging, and nodules (0.1% each).
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).
OVERDOSAGE
When 5% oxiconazole cream (5 times the concentration of the marketed product) was applied at a rate of 1 g/kg to approximately 10% of body surface area of a group of 40 male and female rats for 35 days, 3 deaths and severe dermal inflammation were reported. No overdoses in humans have been reported with use of oxiconazole nitrate cream or lotion.
DOSAGE AND ADMINISTRATION
OXISTAT® Cream or Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. OXISTAT® Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor 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.
Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk that may extend to the neck, arms, and upper thighs. Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea (pityriasis) versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
CLINICAL STUDIES
The following definitions were applied to the clinical and microbiological outcomes in patients enrolled in the clinical trials that form the basis for the approvals of OXISTAT® Lotion and OXISTAT® Cream.
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 eva luation of 90% clinical improvement and a microbiologic eradication (see above) at the 2-week post-treatment visit.
HOW SUPPLIED
OXISTAT® (oxiconazole nitrate cream) Cream, 1% is supplied in:
• 15-g tubes (NDC 0462-0358-15),
• 30-g tubes (NDC 0462-0358-30), and
• 60-g tubes (NDC 0462-0358-60).
Store between 15° and 30° C (59° and 86° F).