DRUGS & SUPPLEMENTS

Econazole LP

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Econazole LP uses


1 INDICATIONS AND USAGE

Econazole LP (econazole nitrate) topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.

Econazole LP is an azole antifungal indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. (1)

2 DOSAGE AND ADMINISTRATION

Econazole LP topical foam, 1% is for topical use only. Econazole LP topical foam, 1% is not for oral, ophthalmic, or intravaginal use.

Econazole LP 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. (2)
  • Apply once daily for 4 weeks. (2)

3 DOSAGE FORMS AND STRENGTHS

Foam, 1%. Each gram of Econazole LP topical foam, 1%, contains 10 mg of Econazole LP in a white to off-white foam.

Foam, 1%. (3)

4 CONTRAINDICATIONS

None.

None. (4)

5 WARNINGS AND PRECAUTIONS

Contents are flammable. Instruct the patient to avoid heat, flame, and/or smoking during and immediately following application.

5.1 Flammability

Econazole LP 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.

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6 ADVERSE REACTIONS

During clinical trials with Econazole LP topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Econazole LP and vehicle arms.

To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA Dermatology, LLC. at 1-877-324-9349 or FDA at 1-800-FDA-1088 or www.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 Econazole LP topical foam or vehicle (246 subjects were exposed to Econazole LP topical foam, 1% and 249 were exposed to vehicle). Subjects with interdigital tinea pedis applied foam or vehicle once daily for approximately 28 days. During clinical trials with Econazole LP topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Econazole LP and vehicle arms. 

7 DRUG INTERACTIONS

7.1 Warfarin

Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulant effect. Most cases reported product application with use under occlusion, genital application, or application to a large body surface area which may increase the systemic absorption of Econazole LP. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

There are no adequate and well-controlled trials with Econazole LP topical foam in pregnant women. Econazole LP topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Econazole LP 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.

8.3 Nursing Mothers

It is not known whether Econazole LP is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Econazole LP is administered to a nursing woman. Following oral administration of Econazole LP to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups.

8.4 Pediatric Use

Of the 173 subjects treated with Econazole LP topical foam, 1% in the clinical trials, 2 subjects were 12-17 years old.  In a pediatric maximal use trial, Econazole LP topical foam, 1% was applied once daily to eighteen subjects aged 12 to 17 years with interdigital tinea pedis for 28 days [see Clinical Pharmacology ]. The safety findings for subjects 12 to 17 years were similar to those in adult population.

8.5 Geriatric Use

Of the 173 subjects treated with Econazole LP 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.

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11 DESCRIPTION

Econazole LP (econazole nitrate) topical foam, 1% contains the azole antifungal agent, Econazole LP 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 Econazole LP topical foam, 1% contains 10 mg of Econazole LP, USP, in a white to off-white foam. Econazole LP topical foam, 1% is alcohol (ethanol)-free and for topical use only.

Chemically, Econazole LP is 1-[2-{(4-chloro-phenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Econazole LP has the molecular formula C18H15Cl3N2O.HNO3 and a molecular weight of 444.70. Its molecular structure is as follows:

chem structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Econazole LP topical foam is an azole antifungal [see Clinical Pharmacology ] .

12.2 Pharmacodynamics

The pharmacodynamics of Econazole LP topical foam, 1% have not been established.

12.3 Pharmacokinetics

The systemic absorption of Econazole LP 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 with tinea pedis applied Econazole LP topical foam, 1% once daily for 29 days.  Subjects applied a mean daily amount of 2.4 g of Econazole LP topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 29 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 (Tmax) was 6.8 ± 5.1 h with maximum concentration (Cmax) of 417 ± 218 pg/ml. The area under the concentration time curve for the first 12 hours post application on Day 29 (AUC(0-12)) 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 Econazole LP topical foam, 1% once daily for 4 weeks.  Subjects applied a mean daily amount of 3.2 g of Econazole LP topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles.  Blood samples were obtained on Day 28 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 LP, 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 LP has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1) ].

Trichophyton rubrum

Epidermophyton floccosum

Trichophyton mentagrophytes

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies to determine the carcinogenic potential of Econazole LP topical foam have not been performed.

Oral administration of Econazole LP in rats has been reported to produce prolonged gestation.

14 CLINICAL STUDIES

In two multi-center, randomized, double-blind, vehicle-controlled clinical trials a total of 505 subjects with interdigital tinea pedis were randomized 1:1 to Econazole LP topical foam or vehicle; subjects applied the assigned medication once daily for 4 weeks. The severity of erythema, scaling, fissuring, maceration, vesiculation, and pruritus were graded using a 4-point scale (none, mild, moderate, severe). Subjects had KOH examination and fungal cultures taken to confirm eligibility. A total of 339 subjects with positive fungal cultures were evaluated for efficacy. Efficacy was evaluated on Day 43, 2 weeks post-treatment with treatment success being defined as complete cure (negative KOH and fungal culture and no evidence of clinical disease). The study population ranged in age from 12 to 71 years with 3 subjects less than 18 years of age at baseline. The subjects were 71% male and 52% Caucasian. Table 1 presents the efficacy results for each trial.

Study 1 Study 2
Econazole LP topical foam, 1%

N = 82

n(%)

Foam Vehicle

N = 83

n(%)

Econazole LP topical foam, 1%

N = 91

n(%)

Foam Vehicle

N = 83

n(%)

Complete cureMycological cure and an absence of clinical signs and symptoms (erythema, scaling, fissuring, maceration, vesiculation, or pruritus). 19 (23.2%) 2 (2.4%) 23 (25.3%) 4 (4.8%)
Effective treatmentMycological cure and no or mild erythema and/or scaling with all other signs and symptoms absent. 40 (48.8%) 9 (10.8%) 44 (48.4%) 9 (10.8%)
Mycological cureNegative KOH and fungal culture. 56 (68.3%) 13 (15.7%) 61 (67.0%) 15 (18.1%)

16 HOW SUPPLIED/ STORAGE AND HANDLING

Econazole LP topical foam, 1% is white to off-white foam supplied in 70 g (NDC 23710-100-70) 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.

Econazole LP 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.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

The patient should be instructed as follows:

  • Inform patients that Econazole LP (econazole nitrate) topical foam, 1% is for topical use only. Econazole LP (econazole nitrate) topical foam, 1% is not intended for oral, intravaginal, or ophthalmic use.
  • Econazole LP topical foam, 1% is flammable; avoid heat, flame, and smoking during and immediately following application.
  • If a reaction suggesting sensitivity or chemical irritation develops with the use of Econazole LP topical foam, 1%, use of the medication should be discontinued.

Manufactured in the USA for

Exeltis USA Dermatology, LLC

Florham Park, NJ 07932

U.S, Patent 5,993,830

Issued: 07/2016

1007001-01

Patient Information

ECOZA® (ee-ko-zah)

(econazole nitrate) topical foam, 1%

Important information: Econazole LP topical foam is for use on skin only. Do not use Econazole LP topical foam in your eyes or vagina.
What is Econazole LP topical foam?

Econazole LP topical foam is a prescription medicine used on the skin (topical) to treat athlete's foot that is between the toes (interdigital tinea pedis) in people 12 years of age and older.

What should I tell my doctor before using Econazole LP topical foam?

Before using Econazole LP topical foam, tell your doctor about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if Econazole LP topical foam will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Econazole LP topical foam passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Econazole LP topical foam?

See the detailed Instructions for Use for information about how to use Econazole LP topical foam.

  • Use Econazole LP topical foam exactly as your doctor tells you to use it.
  • Apply Econazole LP topical foam to the affected skin areas of your feet 1 time a day for 4 weeks.
  • If Econazole LP topical foam gets in or near your eyes, rinse them well with water.
  • Wash your hands after you apply Econazole LP topical foam.
What should I avoid while using Econazole LP topical foam?
  • Econazole LP topical foam is flammable. Avoid heat, flame and smoking while applying and right after you apply Econazole LP topical foam to your skin.
What are the possible side effects of Econazole LP topical foam?

Econazole LP topical foam may cause skin reactions at the treatment site. Tell your doctor if you have any skin reactions on the areas of your skin treated with Econazole LP topical foam.

These are not all the possible side effects of Econazole LP topical foam.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Econazole LP topical foam?
  • Store Econazole LP topical foam at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Do not refrigerate or freeze Econazole LP topical foam.
  • Do not store Econazole LP topical foam in direct sunlight.
  • Econazole LP topical foam is flammable. Keep the Econazole LP topical foam canister away from heat and temperatures above 120°F (49°C), even if the canister is empty.
  • Do not puncture or burn the Econazole LP topical foam canister.

Keep Econazole LP topical foam and all medicines out of the reach of children.

General information about the safe and effective use of Econazole LP topical foam

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your doctor or pharmacist for information about Econazole LP topical foam that is written for health professionals. Do not use Econazole LP topical foam for a condition for which it was not prescribed. Do not give Econazole LP topical foam to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in Econazole LP topical foam?

Active ingredient: Econazole LP, USP

Inactive Ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant.

Manufactured in the USA for Exeltis USA Dermatology, LLC, Florham Park, NJ 07932

For more information call Exeltis USA Dermatology, LLC. at 1-877- 324-9349.

This Patient Information has been approved by the U.S. Food and Drug Administration.                    Issued: 07/2016

Instructions for Use

ECOZA® (ee-ko-zah)

(econazole nitrate) topical foam, 1%

 Important information: Ecoza® topical foam is for use on skin only. Do not use Econazole LP topical foam in your eyes or vagina.

Parts of Econazole LP topical foam Canister.


                                           Figure A

How to apply Econazole LP topical foam:

Step 1: Before you apply Econazole LP topical foam, shake the Econazole LP topical foam canister for about 5 seconds.
Step 2: Remove the cap and turn the Econazole LP topical foam canister upside down over the palm of your hand.
Step 3: Press down firmly on the actuator until there is a small amount of foam about the size of a golf ball in the palm of your hand.
Figure B Figure C
Step 4: Use your finger-tips to scoop up small amounts of Econazole LP topical foam and apply to the affected skin areas on your feet. Gently rub the foam into the skin.

Figure D

Step 5: You should apply Econazole LP topical foam to your toes, to the spaces between your toes, and to the surrounding areas 1 time a day for 4 weeks or as prescribed by your doctor.
Step 6: Replace the cap. Wash your hands after applying Econazole LP topical foam.

How should I store Econazole LP topical foam?

  • Store Econazole LP topical foam at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Do not refrigerate or freeze Econazole LP topical foam.
  • Do not store Econazole LP topical foam in direct sunlight.
  • Econazole LP topical foam is flammable. Keep the Econazole LP topical foam canister away from heat and temperatures above 120°F (49°C), even if the canister is empty.
  • Do not puncture or burn the Econazole LP topical foam canister.

Keep Econazole LP topical foam and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured in the USA for Exeltis USA Dermatology, LLC, Florham Park, NJ 07932

Issued: 07/2016

figure A figure b figure c Figure d

NDC 23710-100-70

Econazole LP

(econazole nitrate)

topical foam, 1%

For Topical Use Only

Not for ophthalmic, oral or intravaginal use.

Keep Out of Reach of Children

Rx Only

Net Wt 70g

Exeltis

Rethinking healthcare

Econazole LP pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Econazole LP available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Econazole LP destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Econazole LP Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Econazole LP pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ECOZA (ECONAZOLE NITRATE) AEROSOL, FOAM [EXELTIS USA DERMATOLOGY, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "econazole". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "econazole". http://www.drugbank.ca/drugs/DB0112... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Econazole LP?

Depending on the reaction of the Econazole LP after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Econazole LP not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Econazole LP addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Econazole LP, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Econazole LP consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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