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ECONAZOLE NITRATE CREAM, 1% | Econazole Nitrate

13:08 EDT 24th July 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

DESCRIPTION

Econazole Nitrate Cream, 1% contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of pegoxyl 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. The white to off-white soft cream is for topical use only.

Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows:

IMAGE econazole-nc-01.jpg

CLINICAL PHARMACOLOGY

After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum which, by far, exceeded the minimum inhibitory concentration for dermatophytes. Inhibitory concentrations were achieved in the epidermis and as deep as the middle region of the dermis. Less than 1% of the applied dose was recovered in the urine and feces.

Microbiology: Econazole nitrate has been shown to be active against most strains of the following microorganisms, bothin vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

Econazole nitrate exhibits broad-spectrum antifungal activity against the following organismsin vitro ,but the clinical significance of these data is unknown .

Dermatophytes Yeasts
Epidermophyton floccosum Candida albicans
Microsporum audouini Malassezia furfur
Microsporum canis
Microsporum gypseum
Trichophyton mentagrophytes
Trichophyton rubrum
Trichophyton tonsurans
Dermatophytes Yeasts
Trichophyton verrucosum Candida guillermondii
Candida parapsilosis
Candida tropicalis

INDICATIONS AND USAGE

Econazole Nitrate Cream, 1% is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused byTrichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, andEpidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

CONTRAINDICATIONS

Econazole Nitrate Cream, 1% is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

WARNINGS

Econazole Nitrate Cream, 1% is not for ophthalmic use.

PRECAUTIONS

General: If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.

For external use only. Avoid introduction of Econazole Nitrate Cream into the eyes.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies to determine carcinogenic potential have not been performed.

Fertility ( Reproduction ): Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation. Intravaginal administration in humans has not shown prolonged gestation or other adverse reproductive effects attributable to econazole nitrate therapy.

Pregnancy: Teratogenic effects- Pregnancy Category C : Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose.

Econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. The drug should be used during the second and third trimesters of pregnancy only if clearly needed.

Nursing Mothers: It is not know whether econazole nitrate is excreted in human milk. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. Also, in lactating rats receiving large oral doses (40 or 80 times the human dermal dose), there was a reduction in post partum viability of pups and survival to weaning; however, at these high doses, maternal toxicity was present and may have been a contributing factor. Caution should be exercised when econazole nitrate is administered to a nursing woman.

ADVERSE REACTIONS

During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging and erythema. One case of pruritic rash has also been reported.

OVERDOSAGE

Overdosage of econazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 462, 668, 272, and >160 mg/kg, respectively.

DOSAGE AND ADMINISTRATION

Sufficient Econazole Nitrate Cream 1% should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis.

Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

HOW SUPPLIED

Econazole Nitrate Cream 1% is supplied as follows:

NDC 0168-0312-15 15 gram tube

NDC 0168-0312-30 30 gram tube

NDC 0168-0312-85 85 gram tube

Store Econazole Nitrate 1% Cream below 86°F (30°C).

E. FOUGERA & CO. A division of Nycomed US Inc. MELVILLE, NEW YORK 11747

I2312A R12/07 #20

NDC 0168-0312-15

Fougera

ECONAZOLE

NITRATE CREAM, 1%

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

WARNING: Keep out of

reach of children.

NET WT 15 grams

IMAGE econazole-nc-02.jpg

NDC 0168-0312-15

Fougera

ECONAZOLE NITRATE

CREAM, 1%

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

WARNING: Keep out of reach of children.

NET WT 15 grams

IMAGE econazole-nc-03.jpg

NDC 0168-0312-30

Fougera

ECONAZOLE

NITRATE CREAM, 1%

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

WARNING: Keep out of

reach of children.

NET WT 30 grams

IMAGE econazole-nc-04.jpg

NDC 0168-0312-30

Fougera

ECONAZOLE NITRATE

CREAM, 1%

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

WARNING: Keep out of

reach of children.

NET WT 30 grams

IMAGE econazole-nc-05.jpg

NDC 0168-0312-85

Fougera

ECONAZOLE

NITRATE CREAM, 1%

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

WARNING: Keep out of

reach of children.

NET WT 85 grams

IMAGE econazole-nc-06.jpg

NDC 0168-0312-85

Fougera

ECONAZOLE

NITRATE CREAM, 1%

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

WARNING: Keep out of

reach of children.

NET WT 85 grams

IMAGE econazole-nc-07.jpg

Manufacturer

E. FOUGERA & CO. A division of Nycomed US Inc.

Active Ingredients

Source

Clinical Trials [58 Associated Clinical Trials listed on BioPortfolio]

Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream

The primary objective of the study is to evaluate local tolerability of the new Econazole/Benzydamine product, in comparison with the Econazole and Benzydamine stand-alone products and pla...

Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Vaginal Pessary

The primary objective of the study is to evaluate the local tolerability of the new Econazole/Benzydamine pessary, in comparison with Econazole and Benzydamine stand-alone products and pla...

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An exploratory study investigating the direct application of potassium nitrate solutions of different concentrations in reducing dentine hypersensitivity.

The Treatment of Bartholin´s Cyst or Abscess With Silver Nitrate

Silver nitrate treatment of Bartholin's cyst or abscess will be compared to marsupialization treatment. It is expected that silver nitrate treatment is effective, simple, inexpensive and ...

Phase II Gallium Nitrate in Relapsed or Refractory Non-Hodgkin's Lymphoma

Eligible patients will have low- or intermediate-grade Non-Hodgkin's Lymphoma (NHL) that has progressed after standard chemotherapy. Patients will receive gallium nitrate 300 mg/m2/day by...

PubMed Articles [513 Associated PubMed Articles listed on BioPortfolio]

Enhanced removal of nitrate from water using nZVI@MWCNTs composite: synthesis, kinetics and mechanism of reduction.

Herein, multi-wall carbon nanotubes (MWCNTs) were used as the carrier of nano-zero valent iron (nZVI) particles to fabricate a composite known as nZVI@MWCNTs. The composite was then characterized and ...

Temperature and Substrate Control Woodchip Bioreactor Performance in Reducing Tile Nitrate Loads in East-Central Illinois.

Tile drainage is the major source of nitrate in the upper Midwest, and end-of-tile removal techniques such as wood chip bioreactors have been installed that allow current farming practices to continue...

Autotrophic denitrification by nitrate-dependent Fe(II) oxidation in a continuous up-flow biofilter.

A continuous-upflow biofilter packed with sponge iron was constructed for nitrate removal under an anaerobic atmosphere. Microbacterium sp. W5, a nitrate reducing and Fe(II) oxidizing strain, was adde...

Nitrate decontamination through functionalized chitosan in brackish water.

N, N, N-Triethyl ammonium functionalized cross-linked chitosan beads (TEACCB) was prepared by alkylation of glutaraldehyde cross-linked chitosan beads to remove nitrate from brackish water. Physico-ch...

Microbial reduction of nitrate in the presence of zero-valent iron and biochar.

The denitrification of nitrate (NO3(-)) by mixed cultures in the presence of zero-valent iron [Fe(0)] and biochar was investigated through a series of batch experiments. It was hypothesized that bioch...

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