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Econazole topical Pregnancy and Breastfeeding Warnings

Econazole topical is also known as: Ecoza, Spectazole

Econazole topical Pregnancy Warnings

Animal studies have revealed evidence of fetotoxicity and embryotoxicity when given orally at 10 to 80 times the human dermal dose. Econazole has been used in clinical trials for the treatment of vaginal candidiasis, generally during the second and third trimester, without evidence of fetal harm. There are no controlled data with econazole topical foam in human pregnancy. Econazole vaginal cream (not available in the US) has been used for the treatment of vaginal candidiasis in pregnant patients. In a study of 117 pregnant women, duration of pregnancy ranging from 10 to 42 weeks, patients were treated with 150 mg once a day for 3 days. Three stillbirths were recorded. No congenital abnormalities were recorded among any of the infants. In another study, 112 pregnant women were treated with econazole 150 mg vaginal suppositories. No malformations were observed in 99 infants for whom information following delivery was available. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Cream: -First trimester: Econazole topical should be used during pregnancy only if considered essential to the patient's welfare -Second and third trimesters: Econazole topical should be used during pregnancy only if clearly needed. Foam: Econazole topical should be used during pregnancy only if the benefit outweighs the risk to the fetus.

See references

Econazole topical Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes (after oral administration)

See references

References for pregnancy information

  1. Goormans E, Beek JM, Declercq JA, Loendersloot EW, Roelofs HJ, van Zanten A "Efficacy of econazole ('Gyno-Pevaryl' 150) in vaginal candidosis during pregnancy." Curr Med Res Opin 9 (1985): 371-7
  2. "Product Information. Spectazole (econazole)." Ortho Pharmaceutical Corporation, Raritan, NJ.
  3. Balmer JA "Three-day therapy of vulvovaginal candidiasis with econazole: a multicentric study comprising 996 cases." Am J Obstet Gynecol 126 (1976): 436-41

References for breastfeeding information

  1. "Product Information. Spectazole (econazole)." Ortho Pharmaceutical Corporation, Raritan, NJ.

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