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oxiconazole nitrate

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Overview

What is Oxistat?

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 ()-[-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula CHONCI·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.



What does Oxistat look like?



What are the available doses of Oxistat?

Sorry No records found.

What should I talk to my health care provider before I take Oxistat?

Sorry No records found

How should I use Oxistat?

OXISTAT Cream and Lotion are indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to or OXISTAT Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to (see and ).

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.

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.


What interacts with Oxistat?

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



What are the warnings of Oxistat?

Concentrated extracts must be diluted with sterile diluent prior to first use on a patient for treatment or intradermal testing. All concentrates of glycerinated allergenic extracts have the ability to cause serious local and systemic reactions including death in sensitive patients. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and /or death. An allergenic extract should be temporarily withheld from patients or the dose of the extract adjusted downward if any of the following conditions exist: (1) Severe symptoms of rhinitis and/or asthma (2) Infections or flu accompanied by fever and (3) Exposure to excessive amounts of clinically relevant allergen prior to a scheduled injection. When switching patients to a new lot of the same extract the initial dose should be reduced 3/4 so that 25% of previous dose is administered.


What are the precautions of Oxistat?

General:











            Information for Patients:

            Drug Interactions:

            Carcinogenesis, Mutagenesis, Impairment of Fertility:

            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.

            Pregnancy:

            Teratogenic Effects:

            Nursing Mothers:

            Pediatric Use:

            Geriatric Use:


            What are the side effects of Oxistat?

            During clinical trials, of 955 patients treated with oxiconazole nitrate , 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 , 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).


            What should I look out for while using Oxistat?

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

            OXISTAT (oxiconazole nitrate cream)Cream, 1% and OXISTAT (oxiconazole nitrate lotion) Lotion, 1% are not for ophthalmic or intravaginal use.


            What might happen if I take too much Oxistat?

            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.


            How should I store and handle Oxistat?

            Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .OXISTAT (oxiconazole nitrate cream) Cream, 1% is supplied in:Store between 15° and 30° C (59° and 86° F).PharmaDerm Repackaged by: I8358C/IF8358C R2/09 #178 OXISTAT (oxiconazole nitrate cream) Cream, 1% is supplied in:Store between 15° and 30° C (59° and 86° F).PharmaDerm Repackaged by: I8358C/IF8358C R2/09 #178 OXISTAT (oxiconazole nitrate cream) Cream, 1% is supplied in:Store between 15° and 30° C (59° and 86° F).PharmaDerm Repackaged by: I8358C/IF8358C R2/09 #178 OXISTAT (oxiconazole nitrate cream) Cream, 1% is supplied in:Store between 15° and 30° C (59° and 86° F).PharmaDerm Repackaged by: I8358C/IF8358C R2/09 #178 OXISTAT (oxiconazole nitrate cream) Cream, 1% is supplied in:Store between 15° and 30° C (59° and 86° F).PharmaDerm Repackaged by: I8358C/IF8358C R2/09 #178


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            Clinical Information

            Chemical Structure

            No Image found
            Clinical Pharmacology

            Pharmacokinetics:

            Neither in vitro nor in vivo studies have been conducted to establish relative activity between the lotion and cream formulations.

            Non-Clinical Toxicology
            OXISTAT Cream and Lotion are contraindicated in individuals who have shown hypersensitivity to any of their components.

            OXISTAT (oxiconazole nitrate cream)Cream, 1% and OXISTAT (oxiconazole nitrate lotion) Lotion, 1% are not for ophthalmic or intravaginal use.

            Drug Interactions:

            General:

            ®

            ®

            ®

            During clinical trials, of 955 patients treated with oxiconazole nitrate , 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 , 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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            Reference

            This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
            "https://dailymed.nlm.nih.gov/dailymed/"

            While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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            Professional

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            Interactions

            Interactions

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