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Pregnancy: Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/foetal development.
Limited data from available pregnancy databases do not suggest a causal relationship between montelukast and malformations (i.e. limb defects) that have been rarely reported in worldwide post marketing experience.
Montelukast may be used during pregnancy only if it is considered to be clearly essential.
Breast-feeding: Studies in rats have shown that montelukast is excreted in milk (see PHARMACOLOGY: Toxicology: Preclinical safety data under Actions). It is unknown whether montelukast/metabolites are excreted in human milk.
Montelukast may be used in breast-feeding only if it is considered to be clearly essential.
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