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 详细处方信息以本药内容附件PDF文件（20105603232210.pdf）的“原文Priscribing Information”为准
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部分中文OXISTAT处方资料（仅供参考）

硝酸奥昔康唑
【英文名】Oxiconazole nitrate
【中文别名】奥昔康唑硝酸盐
【CAS】64211-46-7
【化学名】Z-2''-(1-咪唑基)-0-(2,4-二氯苄基)-2,4-二氯苯乙酮肟硝酸盐
【中文同义词】硝酸奥昔康唑;(Z)-2'-(1-咪唑基)-O-(2,4-二氯苄基)-2,4-二氯苯乙酮肟硝酸盐;(Z)-1-(2,4-二氯苯基)-2-(1H-咪唑-1-基)乙酮-O-[(2,4-二氯苯基)甲基]肟,硝酸盐;硝酸肟康唑
【类别】化学药品注册分类 3 。
【适应症】用于以下皮肤感染的局部治疗：红发癣菌、须发癣菌或絮状表皮癣菌所致的脚癣、股癣、体癣以及糠秕马拉色霉菌所致的花斑癣（糠疹）的局部治疗；还可用于儿童病人治疗体癣、股癣、脚癣和花斑癣（糠疹）
【药理】硝酸奥昔康唑 (Oxiconazole nitrate )为咪唑类广谱抗真菌药， 具有强力且快速的抗真菌作用，特别是对红发癣菌显示出很强的抗菌活性。 硝酸奥昔康唑 抗真菌活性是通过直接的细胞膜合成抑制作用及对麦角甾醇合成的抑制作用而发挥的。在 10 μ g/mL以上的浓度，硝酸奥昔康唑具有完全抑制真菌细胞膜合成的作用；硝酸奥昔康唑还抑制C 1,14 -脱甲基化反应，在1 μ g/mL以下的浓度条件下，90%以上阻止麦角甾醇合成。硝酸奥昔康唑对于酵母状真菌和双晶性(或二形性)真菌(临床分株)等而言，具有广范围的抗菌谱，它的M I C在10 μ g/mL以下。
【临床】硝酸奥昔康唑的临床代谢试验表明， 在正常人皮肤，硝酸奥昔康唑大部分都能保留在本品作用部位的皮肤角质层中。尿排泄率在到达 120小时之前为0.2%，没有发现粪便中排泄。血浆中浓度在0 ～ 8小时后，全部在略微超过本底（background）值程度。说明 硝酸奥昔康唑在治疗部位浓度高，系统吸收率低，体内无蓄积，可大大减小抗真菌药物常有的毒副作用，尤其是肝肾毒性。 

OXISTAT?
(oxiconazole nitrate cream) Cream, 1%*

OXISTAT?
(oxiconazole nitrate lotion) Lotion, 1%*

*Potency expressed as oxiconazole

FOR TOPICAL DERMATOLOGIC USE ONLY- NOT FOR OPHTHALMIC OR INTRAVAGINAL USE

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DRUG DESCRIPTION
OXISTAT Cream and Lotion 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 empirical formula C18H13ON3Cl4?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.

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INDICATIONS
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.

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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.

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HOW SUPPLIED
OXISTAT Cream, 1% is supplied in 15-g tubes (NDC 0173-0423-00), 30-g tubes (NDC 0173-0423-01), and 60-g tubes (NDC 0173-0423-04). Store between 15° and 30°C (59° and 86°F).

OXISTAT Lotion, 1% is supplied in a 30-mL bottle (NDC 0173-0448-01). Store between 15° and 30°C (59° and 86°F). Shake well before using.

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SIDE EFFECTS
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).

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DRUG INTERACTIONS
Potential drug interactions between OXISTAT and other drugs have not been systematically evaluated.

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WARNINGS
OXISTAT Cream and Lotion are not for ophthalmic or intravaginal use.

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PRECAUTIONS
General: OXISTAT Cream and Lotion are for external dermal use only. Avoid introduction of OXISTAT Cream or Lotion into the eyes or vagina. If a reaction suggesting sensitivity or chemical irritation should occur with the use of OXISTAT Cream or Lotion, treatment should be discontinued and appropriate therapy instituted. If signs of epidermal irritation should occur, the drug should be discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Although no long-term studies in animals have been performed to evaluate carcinogenic potential, no evidence of mutagenic effect was found in 2 mutation assays (Ames test and Chinese hamster V79 in vitro cell mutation assay) or in 2 cytogenetic assays (human peripheral blood lymphocyte in vitro chromosome aberration assay and in vivo micronucleus assay in mice).

Reproductive studies revealed no impairment of fertility in rats at oral doses of 3 mg/kg/day in females (1 times the human dose based on mg/m2) and 15 mg/kg/day in males (4 times the human dose based on mg/m2). However, at doses above this level, the following effects were observed: a reduction in the fertility parameters of males and females, a reduction in the number of sperm in vaginal smears, extended estrous cycle, and a decrease in mating frequency.

Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rabbits, rats, and mice at oral doses up to 100, 150, and 200 mg/kg/day (57, 40, and 27 times the human dose based on mg/m2), respectively, and revealed no evidence of harm to the fetus due to oxiconazole nitrate. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Because oxiconazole is excreted in human milk, caution should be exercised when the drug is administered to a nursing woman.

Pediatric Use: 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.

Geriatric Use: A limited number of patients at or above 60 years of age (n ? 396) have been treated with OXISTAT Cream in US and non-US clinical trials, and a limited number (n = 43) have been treated with OXISTAT Lotion in US clinical trials. The number of patients is too small to permit separate analyses of efficacy and safety. No adverse events were reported with OXISTAT Lotion in geriatric patients, and the adverse reactions reported with OXISTAT Cream in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of OXISTAT Cream and Lotion in geriatric patients is warranted.

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OVERDOSE
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.

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CONTRAINDICATIONS
OXISTAT Cream and Lotion are contraindicated in individuals who have shown hypersensitivity to any of their components.

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 详细处方信息以本药内容附件PDF文件（20105603232210.pdf）的“原文Priscribing Information”为准
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于2010年5月6日更新