Oxiconazole Nitrate Cream 1%

×

Overview

What is Oxiconazole Nitrate Cream 1%?

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 CHONCI4•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 Cream 1% look like?

What are the available doses of Oxiconazole Nitrate Cream 1%?

Sorry No records found.

What should I talk to my health care provider before I take Oxiconazole Nitrate Cream 1%?

Sorry No records found

How should I use Oxiconazole Nitrate Cream 1%?

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

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 Cream 1%?

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

What are the warnings of Oxiconazole Nitrate Cream 1%?

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

What are the precautions of Oxiconazole Nitrate Cream 1%?

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

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

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/m), 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

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.

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.

What are the side effects of Oxiconazole Nitrate Cream 1%?

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 Cream 1%?

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 Cream 1%?

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 Cream 1%?

Store at 25°C (77°F), with excursion permitted from 15°C to 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Do not freeze. Oxiconazole Nitrate Cream, 1% is supplied in:30 g tubes - (NDC 70263-333-01)Store at 20° – 25°C (68° – 77°F)Manufactured by: Taro Pharmaceuticals Inc.Brampton, Ontario, Canada L6T 1C1Distributed by: Welgo LLC4572 Beech Road, Temple Hills MD 20748Maryland (MD) 20748, USA185560WELGOOxiconazole Nitrate Cream, 1% is supplied in:30 g tubes - (NDC 70263-333-01)Store at 20° – 25°C (68° – 77°F)Manufactured by: Taro Pharmaceuticals Inc.Brampton, Ontario, Canada L6T 1C1Distributed by: Welgo LLC4572 Beech Road, Temple Hills MD 20748Maryland (MD) 20748, USA185560WELGOOxiconazole Nitrate Cream, 1% is supplied in:30 g tubes - (NDC 70263-333-01)Store at 20° – 25°C (68° – 77°F)Manufactured by: Taro Pharmaceuticals Inc.Brampton, Ontario, Canada L6T 1C1Distributed by: Welgo LLC4572 Beech Road, Temple Hills MD 20748Maryland (MD) 20748, USA185560WELGOOxiconazole Nitrate Cream, 1% is supplied in:30 g tubes - (NDC 70263-333-01)Store at 20° – 25°C (68° – 77°F)Manufactured by: Taro Pharmaceuticals Inc.Brampton, Ontario, Canada L6T 1C1Distributed by: Welgo LLC4572 Beech Road, Temple Hills MD 20748Maryland (MD) 20748, USA185560WELGOOxiconazole Nitrate Cream, 1% is supplied in:30 g tubes - (NDC 70263-333-01)Store at 20° – 25°C (68° – 77°F)Manufactured by: Taro Pharmaceuticals Inc.Brampton, Ontario, Canada L6T 1C1Distributed by: Welgo LLC4572 Beech Road, Temple Hills MD 20748Maryland (MD) 20748, USA185560WELGO

×

Clinical Information

Chemical Structure

No Image found

Clinical Pharmacology

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/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.

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; . 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

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.

The concomitant administration of methenamine hippurate and sulfamethizole or sulfathiazole is liable to result in the formation of a precipitate in the urine.

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

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

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/m), 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

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.

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).

×

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.

×

Review

×

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

×

Tips

×

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).

Disclaimer: