Diclegis Use In Pregnancy & Lactation

Pregnancy: This medicinal product is intended for use in pregnant women.
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformative nor feto/neonatal toxicity of doxylamine hydrogen succinate and pyridoxine hydrochloride.
Breast-feeding: The molecular weight of doxylamine hydrogen succinate is low enough that passage into breast milk can be expected.
Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine hydrogen succinate through breast milk. Infants with apnoea or other respiratory syndromes may be particularly vulnerable to the sedative effects of this medicinal product resulting in worsening of their apnoea or respiratory conditions.
Pyridoxine hydrochloride/metabolites are excreted into human milk. There have been no reports of adverse reactions in infants presumably exposed to pyridoxine hydrochloride through human milk.
As newborn infants may be more sensitive to the effects of the antihistamines and to paradoxical irritability and excitation, a risk to newborns/infants cannot be excluded. This medicinal product is not recommended during lactation.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from this medicinal product therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: No human data available.