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Metronidazole topical Pregnancy and Breastfeeding Warnings

Metronidazole topical is also known as: MetroCream, MetroGel, MetroGel-Vaginal, MetroLotion, Noritate, Nuvessa, Rosaclear, Rosadan, Rozex, Vandazole, Vitazol

Metronidazole topical Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed. -According to some authorities: Use is not recommended. AU TGA pregnancy category: B2 US FDA pregnancy category: B

Animal studies with topical formulations have not been reported. Animal studies with the oral formulation have failed to reveal evidence of impaired fertility, teratogenicity, or fetal harm at higher doses. However, some intrauterine deaths were observed in mice when this drug was administered intraperitoneally. There has also been evidence of this drug acting as a carcinogen in rodents. This drug crosses the placenta and rapidly enters fetal circulation. Published data in more than 5000 pregnant women who used this drug during pregnancy (majority during the first trimester) included reports of increased risk of cleft lip, with or without cleft palate; however these finding cannot be confirmed. The majority of studies did not show an increased risk for congenital anomalies or other adverse fetal outcomes. There are no controlled data in human pregnancy. AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Metronidazole topical Breastfeeding Warnings

Neither topical nor vaginal formulations of this drug have been studied during breastfeeding. Following vaginal administration, plasma levels are less than 2% of those after a 500 mg oral dose. Following topical administration, blood levels are about 1% of the peak plasma levels after a 250 mg oral dose.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -After oral administration, this drug is secreted in breast milk in concentrations similar to those found in the plasma. -Since some drug may be systemically absorbed following vaginal administration, excretion in human milk following topical use is possible. -Due to the potential for tumorigenicity in animal studies, a nursing mother may choose to pump and discard her milk during therapy and for 24 hours after therapy ends and feed her infant stored human milk or formula.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. MetroNIDAZOLE Vaginal (metroNIDAZOLE topical)." Oceanside Pharmaceuticals, Bridgewater, NJ.
  4. "Product Information. Rosadan (metroNIDAZOLE topical)." Medimetriks Pharmaceuticals Inc, Fairfield, NJ.
  5. "Product Information. Vandazole (metroNIDAZOLE topical)." Upsher-Smith Laboratories Inc, Minneapolis, MN.
  6. "Product Information. MetroNIDAZOLE Topical (metroNIDAZOLE topical)." G & W Laboratories Inc, South Plainfield, NJ.
  7. "Product Information. Metrogel (metronidazole)." Galderma Laboratories Inc, Fort Worth, TX.
  8. "Product Information. MetroLotion (metroNIDAZOLE topical)." Galderma Laboratories Inc, Cranbury, NJ.
  9. "Product Information. Noritate (metroNIDAZOLE topical)." sanofi-aventis, Bridgewater, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Rosadan (metroNIDAZOLE topical)." Medimetriks Pharmaceuticals Inc, Fairfield, NJ.
  3. "Product Information. Vandazole (metroNIDAZOLE topical)." Upsher-Smith Laboratories Inc, Minneapolis, MN.
  4. "Product Information. MetroNIDAZOLE Topical (metroNIDAZOLE topical)." G & W Laboratories Inc, South Plainfield, NJ.
  5. "Product Information. MetroLotion (metroNIDAZOLE topical)." Galderma Laboratories Inc, Cranbury, NJ.
  6. "Product Information. Noritate (metroNIDAZOLE topical)." sanofi-aventis, Bridgewater, NJ.
  7. "Product Information. Metrogel (metronidazole)." Galderma Laboratories Inc, Fort Worth, TX.
  8. Cerner Multum, Inc. "Australian Product Information." O 0
  9. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  10. "Product Information. MetroNIDAZOLE Vaginal (metroNIDAZOLE topical)." Oceanside Pharmaceuticals, Bridgewater, NJ.

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