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Econazoleadvertisement
Econazole uses
1 INDICATIONS AND USAGEEconazole (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 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 ADMINISTRATIONEconazole topical foam, 1% is for topical use only. Econazole topical foam, 1% is not for oral, ophthalmic, or intravaginal use. Econazole topical foam, 1% should be applied to cover affected areas once daily for 4 weeks.
3 DOSAGE FORMS AND STRENGTHSFoam, 1%. Each gram of Econazole topical foam, 1%, contains 10 mg of Econazole in a white to off-white foam. Foam, 1%. (3) 4 CONTRAINDICATIONSNone. None. (4) 5 WARNINGS AND PRECAUTIONSContents are flammable. Instruct the patient to avoid heat, flame, and/or smoking during and immediately following application. 5.1 FlammabilityEconazole 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. advertisement
6 ADVERSE REACTIONSDuring clinical trials with Econazole topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Econazole 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 ExperienceBecause 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 topical foam or vehicle (246 subjects were exposed to Econazole 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 topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Econazole and vehicle arms. 7 DRUG INTERACTIONS7.1 WarfarinConcomitant 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. 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. advertisement
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyPregnancy Category C There are no adequate and well-controlled trials with Econazole topical foam in pregnant women. Econazole topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Econazole 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 MothersIt is not known whether Econazole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Econazole is administered to a nursing woman. Following oral administration of Econazole to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. 8.4 Pediatric UseOf the 173 subjects treated with Econazole topical foam, 1% in the clinical trials, 2 subjects were 12-17 years old. In a pediatric maximal use trial, Econazole 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 UseOf the 173 subjects treated with Econazole 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. advertisement
11 DESCRIPTIONEconazole (econazole nitrate) topical foam, 1% contains the azole antifungal agent, Econazole 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 topical foam, 1% contains 10 mg of Econazole, USP, in a white to off-white foam. Econazole topical foam, 1% is alcohol (ethanol)-free and for topical use only. Chemically, Econazole is 1-[2-{(4-chloro-phenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Econazole has the molecular formula C18H15Cl3N2O.HNO3 and a molecular weight of 444.70. Its molecular structure is as follows: 12 CLINICAL PHARMACOLOGY12.1 Mechanism of ActionEconazole topical foam is an azole antifungal [see Clinical Pharmacology ] . 12.2 PharmacodynamicsThe pharmacodynamics of Econazole topical foam, 1% have not been established. 12.3 PharmacokineticsThe systemic absorption of Econazole 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 topical foam, 1% once daily for 29 days. Subjects applied a mean daily amount of 2.4 g of Econazole 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 topical foam, 1% once daily for 4 weeks. Subjects applied a mean daily amount of 3.2 g of Econazole 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, 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 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 advertisement
13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityLong-term animal studies to determine the carcinogenic potential of Econazole topical foam have not been performed. Oral administration of Econazole in rats has been reported to produce prolonged gestation. 14 CLINICAL STUDIESIn 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 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.
16 HOW SUPPLIED/ STORAGE AND HANDLINGEconazole 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 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 INFORMATIONSee FDA-approved patient labeling (Patient Information) The patient should be instructed as follows:
Manufactured in the USA for Exeltis USA Dermatology, LLC Florham Park, NJ 07932 U.S, Patent 5,993,830 Issued: 07/2016 1007001-01
Instructions for UseECOZA® (ee-ko-zah) (econazole nitrate) topical foam, 1%
Parts of Econazole topical foam Canister. Figure A How to apply Econazole topical foam:
How should I store Econazole topical foam?
Keep Econazole 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 (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 pharmaceutical active ingredients containing related brand and generic drugs: Active 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 available forms, composition, doses:Form 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 destination | category:Destination 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 Anatomical Therapeutic Chemical codes:A 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 pharmaceutical companies:Pharmaceutical 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
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Econazole?Depending on the reaction of the Econazole after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Econazole 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 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. advertisement
ReviewsDrugs.com conducted a study on Econazole, 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 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.Visitor reportsOne visitor reported frequency of useHow often in a day do you take the medicine?Are you taking the Econazole drug as prescribed by the doctor? Few medications can be taken Twice in a day more than prescribed when the doctor's advice mentions the medicine can be taken according to frequency or severity of symptoms. Most times, be very careful and clear about the number of times you are taking the medication. The report of sDrugs.com website users about the frequency of taking the drug Econazole is mentioned below.
Two visitors reported dosesWhat is the dose of Econazole drug you are taking?According to the survey conducted among sDrugs.com website users, the maximum number of people are using the following dose 101-200mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
One visitor reported age
Visitor reviews
The information was verified by Dr. Arunabha Ray, MD Pharmacology |
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