Impairment of fertility ? Atomoxetine HCl did not impair fertility in rats when given in the diet at doses of up to 57 mg/ kg/ day, which is approximately 6 times the maximum human dose on a mg/ m 2 basis. Pregnancy Pregnancy Category C ? Pregnant rabbits were treated with up to 100 mg/ kg/ day of atomoxetine by gavage throughout the period of organogenesis. At this dose, in 1 of 3 studies, a decrease in live fetuses and an increase in early resorptions was observed. Slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery were observed. These findings were observed at doses that caused slight maternal toxicity. The no-effect dose for these findings was 30 mg/ kg/ day. The 100-mg/ kg dose is approximately 23 times the maximum human dose on a mg/ m 2 basis; plasma levels (AUC) of atomoxetine at this dose in rabbits are estimated to be 3.3 times (extensive metabolizers) or 0.4 times (poor metabolizers) those in humans receiving the maximum human dose. Rats were treated with up to approximately 50 mg/ kg/ day of atomoxetine (approximately 6 times the maximum human dose on a mg/ m 2 basis) in the diet from 2 weeks (females) or 10 weeks (males) prior to mating through the periods of organogenesis and lactation. In 1 of 2 studies, decreases in pup weight and pup survival were observed. The decreased pup survival was also seen at 25 mg/ kg (but not at 13 mg/ kg). In a study in which rats were treated with atomoxetine in the diet from 2 weeks (females) or 10 weeks (males) prior to mating throughout the period of organogenesis, a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at 40 mg/ kg/ day (approximately 5 times the maximum human dose on a mg/ m 2 basis) but not at 20 mg/ kg/ day. | ||||
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