Use during Pregnancy, Delivery or Lactation: There are no data on the safety of rabeprazole in human pregnancy. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the foetus due to rabeprazole sodium, although low foeto-placental transfer occurs in rats. PARIET is contraindicated during pregnancy.
[Fetotoxicity (delayed ossification in rats, weight loss and delayed ossification in rabbits) has been reported with PARIET in animal studies (400 mg/kg p.o. in rats, 30 mg/kg i.v. in rabbits).]
It is not known whether rabeprazole sodium is excreted in human breast milk. No studies in lactating women have been performed. Rabeprazole sodium is however excreted in rat mammary secretions. Therefore PARIET should not be used during breast feeding.
[In an animal study (in rats), it has been reported that PARIET is excreted in breast milk.]