Asthmatin/Asthmatin 4 Use In Pregnancy & Lactation

Pregnancy: Asthmatin: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, montelukast should be used during pregnancy only if clearly essential.
Asthmatin 4: 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 may be used during pregnancy only if it is considered to be clearly essential.
Lactation: Asthmatin: It is not known if montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when montelukast is given to a nursing mother.
Asthmatin 4: Studies in rats have shown that montelukast is excreted in milk. It is unknown whether montelukast/metabolites are excreted in human milk. Montelukast may be used in breast-feeding mothers only if it is considered to be clearly essential.