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Pregnancy: There are no adequate and well-controlled studies to date using Montelukast in pregnant women. Montelukast should be used during pregnancy only when clearly needed. A causal relationship between Montelukast use and the development of these congenital anomalies has not been established.
Lactation: Since it is not known whether Montelukast is distributed in human milk, the drug should be used with caution in nursing women.
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