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Oxiconazole Nitrate (Oxiconazole Nitrate)

Trade Name : Oxiconazole Nitrate

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

CREAM

Strength 10 mg/g

OXICONAZOLE NITRATE Azole Antifungal [EPC],Azoles [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oxiconazole Nitrate (Oxiconazole Nitrate) which is also known as Oxiconazole Nitrate and Manufactured by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. It is available in strength of 10 mg/g per ml. Read more

Oxiconazole Nitrate (Oxiconazole Nitrate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Oxiconazole nitrate cream, 1% contains the antifungal active compound oxiconazole nitrate. This formulation is for topical dermatologic use only.
  • Chemically, oxiconazole nitrate is 2u00b4,4u00b4-dichloro-2-imidazol-1-ylacetophenone ()-[-(2,4-dichlorobenzyl)oxime], mononitrate. The compound has the molecular formula CHONCIu2022HNO, 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 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.
  • No data
  • Oxiconazole nitrate cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to u00a0or Oxiconazole nitrate cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to (see n 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 is contraindicated in individuals who have shown hypersensitivity to any of their components.
  • Oxiconazole nitrate cream, 1% is not for ophthalmic or intravaginal use.
  • No data
  • 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).
  • 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.
  • 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.
  • The following definitions were applied to the clinical and microbiological outcomes in patients enrolled in the clinical trials that form the basis for the approval of oxiconazole nitrate cream.
  • Definitions:
  • Tinea Pedis: THERE ARE NO HEAD-TO-HEAD COMPAR ISON TRIALS OF THE OXICONAZOLE NITRATE CREAM AND LOTION FORMULATIONS IN THE TREATMENT OF TINEA PEDIS.
  • The two pivotal trials for the oxiconazole nitrate cream formulation involved 281 evaluable patients (total from both trials) with clinically and microbiologically established tinea pedis.
  • The combined results of these 2 clinical trials at the 2-week post-treatment follow-up visit are shown in the following table:
  • All the improvement and cure rates of the b.i.d.- and q.d.- treated groups did not differ significantly (95% confidence interval) from each other but were statistically (95% confidence interval) superior to the vehicle-treated group.
  • In addition, pediatric data (95 children ages 10 and under) available with the cream formulation indicate that it is safe and effective for use in children when used as directed. Adverse events were reported in 2 children; 1 child was reported to have reddening of the skin and 1 child was reported to have eczema-like skin alterations.
  • Tinea (pityriasis) Versicolor:
  • Only once a day was shown in both studies to be statistically superior to vehicle for all efficacy parameters at 2 weeks and follow-up.
  • Oxiconazole nitrate cream, 1% is supplied in:
  • Store between 15u00b0 and 30u00b0C (59u00b0 and 86u00b0F).
  • E. FOUGERA & CO.n n- Arrayn- Array
  • 46144436AR09/14#316
  • NDC
  • OXICONAZOLENITRATE CREAM, 1%n n
  • For Topical Dermatologic Use ONLY -Not for Ophthalmic or Intravaginal Use.
  • Rx Only
  • NET WT 30 grams
  • NDC
  • Rx Only
  • OXICONAZOLE NITRATE CREAM, 1%n n
  • For Topical Dermatologic Use ONLY -Not for Ophthalmic or Intravaginal Use.
  • NET WT 30 grams

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