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Antipyrine / benzocaine otic Pregnancy and Breastfeeding Warnings

Brand names: 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

See also

References for pregnancy information

  1. Product Information. Auralgan (antipyrine-benzocaine otic). Wyeth-Ayerst Laboratories. 2001;PROD.
  2. Cerner Multum, Inc. Australian Product Information.
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.
  4. Cerner Multum, Inc. Canadian Product Information. 2015.

References for breastfeeding information

  1. Product Information. Auralgan (antipyrine-benzocaine otic). Wyeth-Ayerst Laboratories. 2001;PROD.
  2. Cerner Multum, Inc. Australian Product Information.
  3. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  4. Cerner Multum, Inc. Canadian Product Information. 2015.
  5. Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.

Further information

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

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