Z
ZAFIRLUKAST
Respiratory Agent
PREGNANCY RECOMMENDATION: Limited Human Data—Animal Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION: Limited Human Data—Potential Toxicity
PREGNANCY SUMMARY
Zafirlukast is not teratogenic in animals, and the few adverse outcomes in humans do not demonstrate a pattern that suggests a common cause. However, the human data are limited. One source stated that zafirlukast may be safe to use during pregnancy, but this conclusion was based solely on animal studies (1). A 2000 position statement of the American College of Obstetricians and Gynecologists (ACOG) and the American College of Allergy, Asthma and Immunology (ACAAI) recommended that zafirlukast could be considered in patients with recalcitrant asthma who had shown a uniquely favorable response to the drug prior to becoming pregnant (2).
FETAL RISK SUMMARY
Zafirlukast is an oral selective peptide leukotriene receptor antagonist that is indicated for the prophylaxis and chronic treatment of asthma. It is extensively metabolized to inactive compounds that are primarily eliminated in the feces. Plasma protein binding is >99%. The mean terminal half-life is about 10 hours, but other studies have reported the plasma half-lives in the 8- to 16-hour range (3).
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