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Antipyrine / benzocaine otic Pregnancy and Breastfeeding Warnings

Antipyrine / benzocaine otic is also known as: A/B Otic, Allergen, Aurax, Aurodex, Aurogard, Auroto, Dolotic, OtiLam, Otic Care, Otigesic, Rx-Otic

Antipyrine / benzocaine otic Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: Not formally assigned to a pregnancy category. This class of drugs is generally exempt from pregnancy classification.
US FDA pregnancy category: C

Animal studies have not been reported. There are no controlled data in human pregnancy.

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

Antipyrine / benzocaine otic Breastfeeding Warnings

Caution is recommended.

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

Comments:
-Patients given single, oral doses of antipyrine expressed low levels of the drug in breastmilk after 10 minutes.
-Systemic absorption of benzocaine is increased in mucous membranes and traumatized skin.
-There are reports of severe methemoglobinemia in infants who ingested topical benzocaine during nursing.

See references

References for pregnancy information

  1. "Product Information. Auralgan (antipyrine-benzocaine otic)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. Available from: URL: http://www.tga.gov.au/docs/html/medpreg.htm." ([1999]):
  4. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):

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. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
  3. "Product Information. Auralgan (antipyrine-benzocaine otic)." Wyeth-Ayerst Laboratories, Philadelphia, PA.
  4. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  5. 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.

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