Quantia 25/Quantia 100 Use In Pregnancy & Lactation

Fertility: In male Sprague-Dawley rats, the interval to mate and the number of matings required to produce pregnancy increased at Quetiapine doses equivalent to 0.6 and 1.8 times the MRHD on a mg/m² basis. These effects were still present 2 weeks after discontinuation of Quetiapine in the rats that had received 1.8 times of MRHD. No effects on mating or fertility were seen in male rats receiving ≤ 0.3 times the MRHD on a mg/m² basis. In female Sprague-Dawley rats, the interval to mate increased and the number of matings resulting in pregnancy decreased at a Quetiapine dose equivalent to 0.6 times the MRHD on a mg/m² basis. Irregular estrus cycles increased at doses equivalent to 0.1 and 0.6 times the MRHD on a mg/m² basis. No effects on estrus, mating, or fertility were seen in female rats receiving ≤ 0.01 times the MRHD on a mg/m² basis.
Pregnancy: Adequate and well-controlled studies in humans have not been done.
Quetiapine showed no teratogenic potential in rats and rabbits, dosed at 0.3 to 2.4 and 0.6 to 2.4 times the MRHD on a mg/m² basis, respectively, during the period of organogenesis. However, in rats, delays in skeletal ossification were seen in fetuses at all doses. Also, reduced fetal body weight and reduced maternal weight gain and/or increased maternal deaths were seen at the highest dose used. In rabbits, reduced maternal weight gain and/or increased maternal deaths were seen at all doses, delays in skeletal ossification in the fetuses were seen at doses of 1.2 and 2.4 times the MRHD on a mg/m² basis, and reduced fetal body weight and an increased incidence of minor soft tissue anomaly in the fetuses were seen at the highest dose used. In a perinatal/postnatal study in rats receiving 0.01 to 0.24 times the MRHD on a mg/m² basis, no drug-related effects were observed. However, in a preliminary perinatal/postnatal study in rats receiving three times the MRHD on a mg/m² basis, increase in fetal and pup deaths and decreases in mean litter weight were found. FDA Pregnancy Category C.
Breastfeeding: Quetiapine is distributed into the milk of animals. It is not known whether Quetiapine is distributed into breast milk, but breast-feeding while taking Quetiapine is not recommended.