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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. The vaginal formulations have 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 the topical formulations in human pregnancy. The vaginal cream 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 150 mg vaginal suppositories. No malformations were observed in 99 infants for whom information following delivery was available. Systemic absorption is low when this drug is applied topically to intact human skin. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US 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.

Topical Cream: This drug should be used during the first trimester of pregnancy only if considered essential to patient welfare and should be used during the second and third trimesters of pregnancy only if clearly needed; according to some experts, use is not recommended. Topical Foam: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. Vaginal Formulations: This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: A US FDA pregnancy category: C

See references

Econazole topical Breastfeeding Warnings

Use is considered acceptable; caution is recommended. According to some experts, a decision should be made to discontinue breastfeeding or discontinue the topical cream, taking into account the importance of the drug to the mother and the benefit of breastfeeding to the infant. Excreted into human milk: Unknown Excreted into animal milk: Yes (after oral administration) Comments: -The effects in the nursing infant are unknown; low risk is expected (less than 1% absorbed after topical use). -Application to the nipple area should be avoided.

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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL:" ([1999]):
  4. Balmer JA "Three-day therapy of vulvovaginal candidiasis with econazole: a multicentric study comprising 996 cases." Am J Obstet Gynecol 126 (1976): 436-41
  5. "Product Information. Spectazole (econazole)." Ortho Pharmaceutical Corporation, Raritan, NJ.
  6. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL:" ([2014, Nov -]):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Spectazole (econazole)." Ortho Pharmaceutical Corporation, Raritan, NJ.
  4. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL:" ([2014, Nov -]):

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