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Racepinephrine Pregnancy and Breastfeeding Warnings

Brand names: Asthmanefrin, Micronefrin, Nephron, S2 Inhalant

Medically reviewed by Drugs.com. Last updated on Dec 1, 2023.

Racepinephrine Pregnancy Warnings

Animal studies are not available. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use of racepinephrine during pregnancy.
-Racepinephrine is a racemic mixture of both the D- and L-isomers of epinephrine; epinephrine contains only the L-isomer.
-Epinephrine freely crosses the placenta and may be teratogenic in some species, but does not appear to be teratogenic in humans.
-In the Collaborative Perinatal Project, there was a statistically significant association between the use of epinephrine during pregnancy and major and minor malformations, including inguinal hernia.

See references

Racepinephrine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

See references

References for pregnancy information

  1. Product Information. S2 Inhalant (racepinephrine). Nephron Pharmaceuticals. 2010.
  2. Product Information. Asthmanefrin (racepinephrine). Nephron Pharmaceuticals. 2018.
  3. Inc, Insys Development Company. United States Patent Application US 2017/0216199 A1. Epinephrine Spray Formulations. https://patentimages.storage.googleapis.com/30/75/33/63d897fbbc0b16/US20170216199A1.pdf 2018.

References for breastfeeding information

  1. Product Information. S2 Inhalant (racepinephrine). Nephron Pharmaceuticals. 2010.
  2. Product Information. Asthmanefrin (racepinephrine). Nephron Pharmaceuticals. 2018.

Further information

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