Oxiconazole Nitrate

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Overview

What is Oxiconazole Nitrate?

Oxiconazole nitrate cream, 1% contains the antifungal active compound oxiconazole nitrate. This formulation is 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.

Oxiconazole nitrate cream, 1% contains 10 mg of oxiconazole per gram of cream in a white to off-white cream base of cetyl alcohol, polysorbate 60, propylene glycol, purified water, stearyl alcohol, white petrolatum, and benzoic acid 0.2% as a preservative.

What does Oxiconazole Nitrate look like?

What are the available doses of Oxiconazole Nitrate?

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

Sorry No records found

How should I use Oxiconazole Nitrate?

Oxiconazole nitrate cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to , , or . Oxiconazole nitrate cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to (see and ).

Oxiconazole nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which oxiconazole nitrate cream has been shown to be effective rarely occur in children below the age of 12.

Oxiconazole nitrate cream should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Oxiconazole nitrate 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 Oxiconazole Nitrate?

Oxiconazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of their components.

What are the warnings of Oxiconazole Nitrate?

Severe conduction abnormalities have been documented in < 1% of patients during paclitaxel injection therapy and in some cases requiring pacemaker placement. If patients develop significant conduction abnormalities during paclitaxel infusion, appropriate therapy should be administered and continuous cardiac monitoring should be performed during subsequent therapy with paclitaxel injection.

What are the precautions of Oxiconazole Nitrate?

General

Oxiconazole nitrate cream is for external dermal use only. Avoid introduction of oxiconazole nitrate cream into the eyes or vagina. If a reaction suggesting sensitivity or chemical irritation should occur with the use of oxiconazole nitrate cream, treatment should be discontinued and appropriate therapy instituted. If signs of epidermal irritation should occur, the drug should be discontinued.

Information for Patients

Use oxiconazole nitrate cream 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. Oxiconazole nitrate cream is for external use only.
Use the medication for the 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).
Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing.
Avoid the use of occlusive dressings unless otherwise directed by the physician.
Do not use this medication for any disorder other than that for which it was prescribed.

The patient should be instructed to:

Drug Interactions

Potential drug interactions between oxiconazole nitrate cream and other drugs have not been systematically evaluated.

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.

Pregnancy

Nursing Mothers

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

Pediatric Use

Oxiconazole nitrate cream may be used in pediatric patients for tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor; however, these indications for which oxiconazole nitrate 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 oxiconazole nitrate cream in US and non-US clinical trials, and a limited number (n = 43) have been treated with oxiconazole nitrate 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 oxiconazole nitrate lotion in geriatric patients, and the adverse reactions reported with oxiconazole nitrate cream in this population were similar to those reported by younger patients. Based on available data, no adjustment of dosage of oxiconazole nitrate cream in geriatric patients is warranted.

What are the side effects of Oxiconazole Nitrate?

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 Oxiconazole Nitrate?

Oxiconazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of their components.

Oxiconazole nitrate cream is not for ophthalmic or intravaginal use.

What might happen if I take too much Oxiconazole Nitrate?

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 Oxiconazole Nitrate?

Package containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 70385-2009-1Rx onlyPackage containing one epinephrine injection, USP auto-injector 0.3 mg: NDC 70385-2009-1Rx onlyOxiconazole Nitrate Cream, 1% is supplied in:15 g tubes - (NDC 51672-1359-1)30 g tubes - (NDC 51672-1359-2)60 g tubes - (NDC 51672-1359-3)90 g tubes - (NDC 51672-1359-8)Oxiconazole Nitrate Cream, 1% is supplied in:15 g tubes - (NDC 51672-1359-1)30 g tubes - (NDC 51672-1359-2)60 g tubes - (NDC 51672-1359-3)90 g tubes - (NDC 51672-1359-8)

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Clinical Information

Chemical Structure

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Clinical Pharmacology

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/cm of oxiconazole nitrate cream onto human skin, the concentration of oxiconazole nitrate was demonstrated to be 16.2 μmol in the epidermis, 3.64 μmol in the upper corium, and 1.29 μmol 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.

Non-Clinical Toxicology

Oxiconazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of their components.

Oxiconazole nitrate cream is not for ophthalmic or intravaginal use.

Potential drug interactions between oxiconazole nitrate cream and other drugs have not been systematically evaluated.

Oxiconazole nitrate cream is for external dermal use only. Avoid introduction of oxiconazole nitrate cream into the eyes or vagina. If a reaction suggesting sensitivity or chemical irritation should occur with the use of oxiconazole nitrate cream, treatment should be discontinued and appropriate therapy instituted. If signs of epidermal irritation should occur, the drug should be discontinued.

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

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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