The Basics

What is Salmeterol?

Used together with other medicines to control the symptoms of asthma and prevent bronchospasm in patients with asthma.

Brand names for Salmeterol

Serevent Diskus

How Salmeterol is classified

Anti-Asthmatic Agents, Bronchodilator Agents, Beta Adrenergic Agonists

Salmeterol During Pregnancy

Salmeterol 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 Salmeterol while pregnant

There are no adequate and well-controlled trials with SEREVENT DISKUS in pregnant women. Beta2-agonists have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Because animal reproductive studies are not always predictive of human response, SEREVENT DISKUS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women should be advised to contact their physicians if they become pregnant while taking SEREVENT DISKUS. No teratogenic effects occurred in rats at salmeterol doses approximately 160 times the maximum recommended daily inhalation dose (MRHDID) (on a mg/m² basis at maternal oral doses up to 2 mg/kg/day). In pregnant Dutch rabbits administered oral doses approximately 50 times the MRHDID (on an AUC basis at maternal oral doses of 1 mg/kg/day and higher), fetal toxic effects were observed characteristically resulting from beta-adrenoceptor stimulation. These included precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of the frontal cranial bones. No such effects occurred at a salmeterol dose approximately 20 times the MRHDID (on an AUC basis at a maternal oral dose of 0.6 mg/kg/day). New Zealand White rabbits were less sensitive since only delayed ossification of the frontal cranial bones was seen at an oral dose approximately 1,600 times the MRHDID (on a mg/m basis at a maternal oral dose of 10 mg/kg/day). Salmeterol crossed the placenta following oral administration to mice and rats.

Taking Salmeterol While Breastfeeding

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

Although no published data exist on the use of salmeterol 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 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]

Maternal / infant drug levels

Although no published data exist on the use of salmeterol 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 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]

Possible effects of Salmeterol on milk supply

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

Possible alternatives to Salmeterol

Formoterol.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Lindberg C, Boreus LO, de Chateau P et al. Transfer of terbutaline into breast milk. Eur J Resp Dis. 1984;65 (Suppl 134):87-91. PMID: 6586490
2. McDonald CF, Burdon JGW. Asthma in pregnancy and lactation. A position paper for the Thoracic Society of Australia and New Zealand. Med J Aust. 1996;165:485-8. PMID: 8937369
3. Ellsworth A. Pharmacotherapy of asthma while breastfeeding. J Hum Lact. 1994;10:39-41. PMID: 7619245
4. Nelson-Piercy C. Asthma in pregnancy. Thorax. 2001;56:325-8. PMID: 11254828
5. Taddio A, Ito S. Drugs and breast-feeding. In: Koren G, ed. Maternal-fetal toxicology. A clinician’s guide. 3rd ed. New York: Marcel Dekker, 2001:177-32.

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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