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Albuterol / ipratropium Pregnancy and Breastfeeding Warnings

Albuterol / ipratropium is also known as: Combivent, Combivent Respimat, DuoNeb

Medically reviewed on Aug 25, 2017

Albuterol / ipratropium Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comments:
-Teratogenic effect: Albuterol sulfate, a component of this drug, has been shown to be teratogenic in mice.
-Labor and deliver: Because of the potential for beta-agonist interference with uterine contractility, use of this drug for the treatment of COPD during labor should be used only if the benefits clearly outweigh the risk.

Ipratropium bromide: Oral reproduction studies demonstrated no evidence of teratogenic effects. Embryotoxicity was observed as increased resorption in rats at oral large doses, however, this effect is not considered relevant to human use.

Albuterol: It has been shown to be teratogenic in mice and rabbits. A reproduction study in CD-1 mice given albuterol subcutaneously showed cleft palate formation at approximately 14 times the maximum recommended human daily inhalation dose (MRHDID) in adults. None was observed at less than MRHDID in adults. A reproductive study with oral albuterol in Stride Dutch rabbits revealed cranioschisis at approximately 1,100 times the MRHDID in adults. A study with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.

There are no adequate and well-controlled studies of the use of this combination drug or its single components in pregnant women.

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

Albuterol / ipratropium Breastfeeding Warnings

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:
-Ipratropium bromide: Lipid-insoluble quaternary bases pass into breast milk. It is unlikely that this drug would reach the infant to an important extent, especially when taken as a nebulized solution.
-Albuterol: There is a potential for tumorigenicity as shown in animal studies.
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Combivent (albuterol-ipratropium)." Boehringer-Ingelheim, Ridgefield, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Combivent (albuterol-ipratropium)." Boehringer-Ingelheim, Ridgefield, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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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