Albuterol

The Basics

What is Albuterol?

Often used in an inhaler to prevent and treat wheezing and shortness of breath associated with asthma

Brand names for Albuterol

Proair Hfa, Ventolin Hfa, Proair Respiclick

How Albuterol is classified

Anti-Asthmatic Agents, Bronchodilator Agents, Beta Adrenergic Agonists

Albuterol During Pregnancy

Albuterol pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Albuterol while pregnant

There are no adequate and well-controlled studies of PROAIR HFA Inhalation Aerosol or albuterol sulfate in pregnant women. During worldwide marketing experience, variouscongenital anomalies, including cleft palate and limb defects, have been reported in theoffspring of patients treated with albuterol. Some of the mothers were taking multiplemedications during their pregnancies. No consistent pattern of defects can be discerned, and arelationship between albuterol use and congenital anomalies has not been established. Animalreproduction studies in mice and rabbits revealed evidence of teratogenicity. PROAIR HFAInhalation Aerosol should be used during pregnancy only if the potential benefit justifies thepotential risk to the fetus.In a mouse reproduction study, subcutaneously administered albuterol sulfate producedcleft palate formation in 5 of 111 (4.5%) fetuses at an exposure approximately eight-tenths ofthe maximum recommended human dose (MRHD) for adults on a mg/m2 basis and in 10 of 108(9.3%) fetuses at approximately 8 times the MRHD. Similar effects were not observed atapproximately one-thirteenth of the MRHD. Cleft palate also occurred in 22 of 72 (30.5%)fetuses from females treated subcutaneously with isoproterenol (positive control).In a rabbit reproduction study, orally administered albuterol sulfate induced cranioschisisin 7 of 19 fetuses (37%) at approximately 630 times the MRHD.In a rat reproduction study, an albuterol sulfate/HFA-134a formulation administered byinhalation did not produce any teratogenic effects at exposures approximately 65 times theMRHD [see Nonclinical Toxicology (13.2)].

Taking Albuterol While Breastfeeding

What are recommendations for lactation if you're taking Albuterol?

Although no published data exist on the use of albuterol by mouth or inhaler during lactation, data from the related drug, terbutaline, indicate that very little is expected to be excreted into breastmilk.[1] The authors of several reviews and an expert panel agree that use of inhaled bronchodilators is acceptable during breastfeeding because of the low bioavailability and maternal serum levels after use.[2][3][4][5][6]

Maternal / infant drug levels

Although no published data exist on the use of albuterol by mouth or inhaler during lactation, data from the related drug, terbutaline, indicate that very little is expected to be excreted into breastmilk.[1] The authors of several reviews and an expert panel agree that use of inhaled bronchodilators is acceptable during breastfeeding because of the low bioavailability and maternal serum levels after use.[2][3][4][5][6]

Possible effects of Albuterol on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Albuterol

Terbutaline.