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Doxylamine / pyridoxine Pregnancy and Breastfeeding Warnings

Doxylamine / pyridoxine is also known as: Diclegis

Doxylamine / pyridoxine Pregnancy Warnings

FDA pregnancy category: A Use of doxylamine succinate and pyridoxine hydrochloride is considered acceptable.

Treatment of animals during organogenesis with doses 60 to 100 times the highest clinical dose resulted in increased fetal resorptions, decreased fetal body weight and increased skeletal variations with reduce ossifications. Another study of animals treated during organogenesis with doses up to 3.2 times the highest clinical dose showed no malformations or evidence of embryo, fetal or maternal toxicity. A similar animal study observed ventricular septal defects (VSDs) in preterm fetuses at doses 0.5 to 20 times higher than the clinical dose, but there were no VSDs seen in animals at term. Epidemiological studies reported no increased risk for malformation from first trimester exposures as well as no statistical significant relationships between fetal abnormalities and first trimester use. FDA pregnancy category A: Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Doxylamine / pyridoxine Breastfeeding Warnings

Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate. There have been no reports of adverse effects in nursing infants presumably exposed to pyridoxine hydrochloride.

Doxylamine succinate and Pyridoxine should not be used in nursing women. Doxylamine Succinate: Excreted into human milk: Unknown (Doxylamine Succinate); Yes (Pyridoxine) Excreted into animal milk: Unknown (Doxylamine Succinate and Pyridoxine) The effects in the nursing infant are unknown.

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