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Tioconazole topical Pregnancy and Breastfeeding Warnings

Tioconazole topical is also known as: Monistat 1 Vaginal Ointment, Tioconazole 1 Day, Vagistat-1

Medically reviewed by Drugs.com. Last updated on Jan 27, 2020.

Tioconazole topical Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity; although at high doses the incidence of renal abnormalities increased in rat embryos, this effect was minor and transient and not evident in weaned animals. There are no controlled data in human pregnancy.

Even though systemic absorption is insignificant, the manufacturer considers use of the topical solution contraindicated during pregnancy due to the prolonged duration of therapy.

Topical solution: Use is contraindicated.
Vaginal ointment: The manufacturer recommends pregnant women consult a healthcare provider before use of this drug.

US FDA pregnancy category: Not formally assigned to a pregnancy category.

Comments:
-Topical solution: Insufficient evidence available regarding the safety of this drug in human pregnancy; however, absorption is negligible after topical administration.

See references

Tioconazole topical Breastfeeding Warnings

Topical solution: Breastfeeding is not recommended during use of this drug.
Vaginal ointment: An alternative agent may be preferred, especially while breastfeeding newborn or preterm infants; the manufacturer recommends nursing women consult a healthcare provider before use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No data available on the use of the vaginal formulation during breastfeeding.
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Vagistat-1 (tioconazole)." Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. "Product Information. Vagistat-1 (tioconazole)." Bristol-Myers Squibb, Princeton, NJ.
  2. National Library of Medicine (US) "Drugs and Lactation Database (LactMed) Available from: URL: https://www.ncbi.nlm.nih.gov/books/NBK501922/" (2006):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.