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Pregnancy: Pregnancy Category B. No adequate and well-controlled studies in pregnant women are available for montelukast. Montelukast should only be used during pregnancy when clearly needed.
There have been reports of congenital limb defects in children of patients treated with montelukast. Some of the mothers, however, were receiving various medications in the course of their pregnancies. Since there is no consistent pattern of congenital abnormality development, a relationship between the use of montelukast and the development of congenital anomalies cannot be established.
Lactation: It is not known if montelukast is excreted in human milk. Therefore, do not administer to breastfeeding women unless, in the opinion of a physician, the potential benefit of the drug justifies the possible risk to the infant.
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