Low risk. Moderately safe.
Mild risk possible. Follow up recommended.
Comment
It is a first generation antihistaminic and alchylamine drug, with a mild sedative effect.
Irritability, fussiness and insomnia in one infant whose mother was treated with this drug associated to isoephedrine, the latter being thought to be responsible for symptoms, has been described. In Spain, it has been commercialized in association with caffeine: Avoid an extensive use. There is a risk of irritability. (See Caffeine)
Follow-up for sedation and feeding ability of the infant.
Bed-sharing is not recommended for mothers who are taking this medication.