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Miconazole Pregnancy and Breastfeeding Warnings

Miconazole is also known as: Oravig

Medically reviewed by Drugs.com. Last updated on May 29, 2020.

Miconazole Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
-According to some authorities: Benefit should outweigh risk.
-According to some authorities: Use should be avoided if possible.

AU TGA pregnancy category: A
US FDA pregnancy category: C

Animal studies have failed to reveal evidence of embryotoxicity, fetotoxicity, or teratogenicity during IV studies; IV doses of 40 and 20 mg/kg/day in rats and rabbits, respectively, are about 8 times higher than the dose a patient would receive if a buccal tablet was swallowed (based on body surface are comparisons). High oral doses (80 mg/kg/day or higher) resulted in embryofetal toxicity (including fetal resorptions) in rats and rabbits and prolonged gestation and dystocia in rats. This drug was shown to cross the placenta in rats and rabbits. There are no controlled data in human pregnancy.

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.

See references

Miconazole Breastfeeding Warnings

Caution is recommended.
-According to some authorities: Use is not recommended unless it is considered essential or alternative feeding arrangements can be made for the nursing infant.

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

Comments:
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Weisberg M "Treatment of vaginal candidiasis in pregnant women." Clin Ther 8 (1986): 563-7
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Rosa FW, Baum C, Shaw M "Pregnancy outcomes after first-trimester vaginitis drug therapy." Obstet Gynecol 69 (1987): 751-5
  5. Wallenburg HCS, Wladimiroff JW "Recurrence of vulvovaginal candidosis during pregnancy." Obstet Gynecol 48 (1976): 491-4
  6. "Product Information. ORAVIG (miconazole)." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc., Woodcliff Lake, NJ.
  7. McNellis D, Facog, McLeod M, Lawson J, Pasquale SA "Treatment of vulvovaginal candidiasis in pregnancy." Obstet Gynecol 50 (1977): 674-8

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. ORAVIG (miconazole)." Strativa Pharmaceuticals, a Division of Par Pharmaceuticals, Inc., Woodcliff Lake, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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