Econazole

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# Overview
Econazole is a antifungal, imidazole that is FDA approved for the treatment of tinea pedis, tinea cruris, and tinea corporis, cutaneous candidiasis, and in the treatment of tinea versicolor.   Common adverse reactions include application site reaction, burning sensation, erythema, pruritus, stinging of skin.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Econazole Nitrate Cream, 1% is indicated for topical application in the treatment of:
- Tinea pedis, Tinea cruris, Tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum.
- In the treatment of cutaneous candidiasis, and
- In the treatment of tinea versicolor.

### Dosing Information
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Econazole in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Econazole in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- 12 years or older
- Apply topically to affected areas once daily for 1 month

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Econazole in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Econazole in pediatric patients.

# 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
- 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.

# Adverse Reactions

## Clinical Trials Experience
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.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Econazole in the drug label.

# Drug Interactions
- Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econazole nitrate. 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.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 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.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Econazole in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Econazole during labor and delivery.

### 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.

### Pediatric Use
There is no FDA guidance on the use of Econazole with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Econazole with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Econazole with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Econazole with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Econazole in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Econazole in patients with hepatic impairment.

### Females of Reproductive Potential and Males
- 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.

### Immunocompromised Patients
There is no FDA guidance one the use of Econazole in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Topical

### Monitoring
- Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econazole nitrate. 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.

# IV Compatibility
There is limited information regarding IV Compatibility of Econazole in the drug label.

# 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.

# Pharmacology

## Mechanism of Action
- Econazole nitrate is an azole antifungal agent, inhibits fungal CYP450-mediated conversion of lanosterol to ergosterol. Loss of ergosterol in the fungal cell wall may antifungal activity.

## Structure
- Econazole Nitrate Cream, 1% contains the antifungal agent, Econazole Nitrate USP 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.

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

## Pharmacokinetics
- 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.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Econazole in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Econazole in the drug label.

# 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
E. FOUGERA & CO. 
A division of 
Fougera 
PHARMACEUTICALS INC.
Melville, New York 11747
I2312C 
R09/14

## Storage
- Store Econazole Nitrate Cream, 1% below 86F.

# Images

## Drug Images

## Package and Label Display Panel
NDC 0168-0312-15
Fougera 
ECONAZOLE 
NITRATE CREAM, 1%
Rx only
FOR TOPICAL USE ONLY .
KEEP OUT OF THE
REACH OF CHILDREN.
NET WT 15 grams
NDC 0168-0312-15
Rx only
Fougera 
ECONAZOLE 
NITRATE CREAM, 1%
FOR TOPICAL USE ONLY.
KEEP OUT OF THE
REACH OF CHILDREN.
NET WT 15 grams

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Econazole in the drug label.

# Precautions with Alcohol
- Alcohol-Econazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- Spectazole
- Ecoza

# Look-Alike Drug Names
There is limited information regarding Econazole Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price