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Pregnancy and Lactation: Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/foetal development. Available data from published prospective and retrospective cohort studies with montelukast use in pregnant women evaluating major birth defects have not established a drug-associated risk. Available studies have methodologic limitations, including small sample size, in some cases retrospective data collection, and inconsistent comparator groups. Montelukast 10 mg film-coated tablets may be used during pregnancy only if it is considered to be clearly essential.
Breastfeeding: It is unknown whether montelukast is excreted in human milk. Studies in rats have shown that montelukast is excreted in milk. Montelukast 10 mg film-coated tablets may be used in breast-feeding only if it is considered to be clearly essential.
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