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Ecoza

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Ecoza

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Flammability

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.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION)

The patient should be instructed as follows:

  • Inform patients that Ecoza (econazole nitrate) topical foam, 1% is for topical use only. Ecoza (econazole nitrate) topical foam, 1% is not intended for oral, intravaginal, or ophthalmic use.
  • Ecoza 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 Ecoza topical foam, 1%, use of the medication should be discontinued.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation.

Use In Specific Populations

Pregnancy

Pregnancy 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 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.

Nursing Mothers

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.

Pediatric Use

Of the 173 subjects treated with Ecoza topical foam, 1% in the clinical trials, 2 subjects were 1217 years old. In a pediatric maximal use trial, Ecoza 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.

Geriatric Use

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.

Last reviewed on RxList: 11/7/2013
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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