Albuterol / ipratropium Pregnancy and Breastfeeding Warnings

Brand names: Combivent, Combivent Respimat, DuoNeb

Medically reviewed by Drugs.com. Last updated on Sep 25, 2023.

Albuterol / ipratropium Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Ipratropium has negligible systemic absorption after inhalation, so fetal exposure is not expected with maternal use.
-Published literature, including cohort and case control studies and case series over several decades have not identified a risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with ipratropium use.
-Available data from epidemiological studies and postmarketing reports of fetal outcomes after albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage.
-Labor and delivery: Because of the potential for beta-agonist interference with uterine contractility, this drug during labor should be used only if the benefits clearly outweigh the risk.
-Serious adverse reactions (including pulmonary edema) have occurred during or following treatment of premature labor with beta-2 agonists including albuterol.

Ipratropium bromide: Animal 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.

Salbutamol: It has been shown to be teratogenic in mice and rabbits. A reproduction study in CD-1 mice given salbutamol 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 salbutamol in Stride Dutch rabbits revealed cranioschisis at approximately 1,100 times the MRHDID in adults. A study with radiolabeled salbutamol 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. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

See references

Albuterol / ipratropium Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Although lipid-insoluble quaternary cations enter breast milk, plasma levels after inhalation of therapeutic doses of ipratropium are low, as are albuterol concentrations; concentrations in human breast milk are expected to be correspondingly low.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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