ECONAZOLE NOVAGENERICS

Ecoza (econazole nitrate) topical foam, 1% contains the azole antifungal agent, econazole nitrate in an oil-in-water emulsion base consisting of the following inactive ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant.

Each gram of

Ecoza topical foam, 1% contains 10 mg of econazole nitrate, USP, in a white to off-white foam.

Ecoza topical foam, 1% is alcohol (ethanol)-free and for topical use only.

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

Econazole nitrate has the molecular formula

C 18 H 15 Cl 3 N 2 O. HNO and a molecular weight of 444.70.

Its molecular structure is as follows

The local econazole drug is used to treat the following cases: vaginal fungi and surrounding areas.

Innate skin infections, such as: dermatitis, a foot of the athlete or body hyena.

The doctor or pharmacist was consulted before using the local iconazole load in the following cases: when using any other vaginal treatment.

Use of condoms; because such loads reduce its effectiveness, it is recommended that other contraceptive methods be used during the treatment period.

Ecoza topical foam is an azole antifungal. 12.2 Pharmacodynamics The pharmacodynamics of Ecoza topical foam, 1% have not been established. 12.3 Pharmacokinetics The systemic absorption of Ecoza topical foam, 1% following topical application was studied in one clinical trial in adults and one clinical study in pediatric subjects.

In the adult trial, 19 subjects (male and female) with tinea pedis applied Ecoza topical foam, 1% once daily for 29 days.

Subjects applied a mean daily amount of 2.4 g of Ecoza topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles.

Blood samples were obtained on

Day at pre-dose and 1, 2, 4, 6, 8, and 12 hours after application.

Results (mean ± SD) showed the time to reach peak plasma concentrations (T max ) was 6.8 ± 5.1 h with maximum concentration (C max ) of 417 ± 218 pg/ml. The area under the concentration time curve for the first 12 hours post application on Day 29 (AUC ) was 3440 ± 1920 pg-h/ml. In the pediatric trial, 18 subjects (male and female ages 12 - 17) with interdigital tinea pedis and positive fungal cultures were treated with Ecoza topical foam, 1% once daily for 4 weeks.

Subjects applied a mean daily amount of 3.2 g of Ecoza topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles.

Day at pre-dose and 7 h and 11 h post-dose.

The mean ± SD econazole plasma concentration was 397 ± 289, 534 ± 745 and 575 ± 638 pg/mL at pre-dose and 7 h and 11 h post-dose, respectively. 12.4 Microbiology Mechanism of Action Econazole nitrate, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme.

This enzyme functions to convert lanosterol to ergosterol.

The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the fungistatic activity of econazole.

Mammalian cell demethylation is less sensitive to econazole inhibition.

Activity in vitro and in clinical infections Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections.

Trichophyton rubrum Epidermophyton floccosum

Trichophyton mentagrophytes.

Iconazole is an anti-fungal anti-fungal drug, which works by disrupting and weakening the construction of the membrane surrounding the innate cell, killing fungi and preventing their growth, and this drug is used to treat many types of innate infections, such as ovarian foot disease.

Synergy usually starts to improve within one to two weeks of commitment to the use of Ekunazole, but some chronic cases may require a longer treatment.

Do you have questions on this subject? Ask Sina, artificial intelligence to answer all your medical questions.

During clinical trials with

Ecoza topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In two double-blind, vehicle-controlled clinical trials, 495 subjects were exposed to Ecoza topical foam or vehicle (246 subjects were exposed to Ecoza topical foam, 1% and were exposed to vehicle).

Subjects with interdigital tinea pedis applied foam or vehicle once daily for approximately 28 days.

Ecoza topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms.

Ecoza topical foam, 1% is for topical use only.

Ecoza topical foam, 1% is not for oral, ophthalmic, or intravaginal use.

Ecoza topical foam, 1% should be applied to cover affected areas once daily for 4 weeks.

For topical use only; not for oral, ophthalmic, or intravaginal use.

Apply once daily for 4 weeks.

Ecoza topical foam, 1% is white to off-white foam supplied in 10g (NDC 81811-100-10) and 70g (NDC 81811-100-70) aluminum pressurized canister.

Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F).

Do not refrigerate or freeze.

Ecoza topical foam is flammable.

Avoid heat, flame, and smoking during and immediately following application.

Contents under pressure.

Do not puncture and/or incinerate the containers.

Do not expose containers to heat and/or store at temperatures above 120°F (49°C) even when empty.

Do not store in direct sunlight.

Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F).

Do not refrigerate or freeze.

Ecoza topical foam is flammable.

Avoid heat, flame, and smoking during and immediately following application.

Contents under pressure.

Do not puncture and/or incinerate the containers.

Do not expose containers to heat and/or store at temperatures above 120°F (49°C) even when empty.

Do not store in direct sunlight.

Category C There are no adequate and well-controlled trials with Ecoza topical foam in pregnant women.

Ecoza topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 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.

It is not known whether econazole nitrate is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when econazole nitrate is administered to a nursing woman.

Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups.

Of the 173 subjects treated with Ecoza topical foam, 1% in the clinical trials, 2 subjects were to 17 years old.

In a pediatric maximal use trial, Ecoza topical foam, 1% was applied once daily to eighteen subjects aged to 17 years with interdigital tinea pedis for 28 days.

The safety findings for subjects to 17 years were similar to those in adult population.

Of the 173 subjects treated with Ecoza topical foam, 1% in the adult clinical trials, 6 subjects were 65 years or older.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects.