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.
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 also
References for pregnancy information
- Product Information. Auralgan (antipyrine-benzocaine otic). Wyeth-Ayerst Laboratories. 2001.
- Cerner Multum, Inc. Australian Product Information.
- 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.
- Cerner Multum, Inc. Canadian Product Information. 2015.
References for breastfeeding information
- Product Information. Auralgan (antipyrine-benzocaine otic). Wyeth-Ayerst Laboratories. 2001.
- Cerner Multum, Inc. Australian Product Information.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
- Cerner Multum, Inc. Canadian Product Information. 2015.
- 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.