Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4302
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Oxistat (Lotion)
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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.<br/>Geriatric Use: In studies where geriatric patients (65 years of age or
older, see PRECAUTIONS) have been treated with OXISTAT Cream or
Lotion, safety did not differ from that in younger patients;
therefore, no dosage adjustment is recommended.
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| dailymed-instance:descripti... |
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
CHONCl���HNO,
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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| dailymed-instance:clinicalP... |
Pharmacokinetics: The penetration of oxiconazole nitrate into different
layers of the skin was assessed using an in vitro permeation
technique with human skin. Five hours after application of
2.5 mg/cmof oxiconazole nitrate cream onto
human skin, the concentration of oxiconazole nitrate was
demonstrated to be 16.2��mol in the epidermis, 3.64��mol in the
upper corium, and 1.29��mol in the deeper corium. Systemic
absorption of oxiconazole nitrate is low. Using radiolabeled
drug, less than 0.3% of the applied dose of oxiconazole nitrate
was recovered in the urine of volunteer subjects up to 5 days
after application of the cream formulation. Neither in vitro nor in vivo studies have been conducted
to establish relative activity between the lotion and cream
formulations.<br/>Microbiology: Oxiconazole nitrate is an
imidazole derivative whose antifungal activity is derived
primarily from the inhibition of ergosterol biosynthesis, which
is critical for cellular membrane integrity. It has in vitro
activity against a wide range of pathogenic fungi. Oxiconazole has been shown to be active against most
strains of the following organisms both in vitro and in clinical
infections at indicated body sites (see INDICATIONS AND USAGE): Epidermophyton
floccosum Trichophyton
mentagrophytes Trichophyton
rubrum Malassezia
furfur The following in vitro data are available; however, their clinical
significance is unknown. Oxiconazole exhibits satisfactory in vitro minimum
inhibitory concentrations (MICs) against most strains of the
following organisms; however, the safety and efficacy of
oxiconazole in treating clinical infections due to these
organisms have not been established in adequate and
well-controlled clinical trials: Candida
albicans Microsporum
audouini Microsporum
canis Microsporum
gypseum Trichophyton
tonsurans Trichophyton
violaceum
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OXISTAT Cream and Lotion
are contraindicated in individuals who have shown hypersensitivity to
any of their components.
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| dailymed-instance:supply |
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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| dailymed-instance:precautio... |
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, thedrug should be discontinued.<br/>Information for Patients: The patient should be instructed to: 1. Use OXISTAT as directed by the physician. The hands
should be washed after applying the medication to the affected
area(s). Avoid contact with the eyes, nose, mouth, and other
mucous membranes. OXISTAT is for external use only. 2. Use the medication for the full treatment time recommended by the physician,
even though symptoms may have improved. Notify the physician if
there is no improvement after 2 to 4 weeks, or sooner if the
condition worsens (see below). 3. Inform the physician if the area of application shows
signs of increased irritation, itching, burning, blistering,
swelling, or oozing. 4. Avoid the use of occlusive dressings unless otherwise
directed by the physician. 5. Do not use this medication for any disorder other than
that for which it was prescribed.<br/>Drug Interactions: Potential drug interactions between OXISTAT and other
drugs have not been systematically evaluated.<br/>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 time the
human dose based on mg/m) and 15 mg/kg/day in males
(4 times the human dose based on mg/m). 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.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Nursing Mothers: Because oxiconazole is excreted in human milk, caution
should be exercised when the drug is administered to a nursing
woman.<br/>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.<br/>Geriatric Use: A limited number of patients at or above 65 years of age
(n = 508) 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 analysis 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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| dailymed-instance:overdosag... |
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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| dailymed-instance:genericMe... |
oxiconazole nitrate
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Oxistat (Lotion)
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| dailymed-instance:adverseRe... |
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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| dailymed-instance:warning |
OXISTAT Cream and Lotion
are not for ophthalmic or intravaginal use.
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| dailymed-instance:indicatio... |
OXISTAT Cream and Lotion
are indicated for the topical treatment of the following dermal
infections: tinea pedis, tinea cruris, and tinea corporis due toTrichophyton 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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Oxistat
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