Use in pregnancy: Rabeprazole: Teratology studies have been performed in rats at IV doses up to 50 mg/kg/day (plasma AUC of 11.8 mcg•hr/mL, about 13 times the human exposure at the recommended dose for GERD) and rabbits at IV doses up to 30 mg/kg/day (plasma AUC of 7.3 mcg•hr/mL, about 8 times the human exposure at the recommended dose for GERD) and have revealed no evidence of impaired fertility or harm to the fetus due to rabeprazole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Rablet-D should be used during pregnancy only if clearly needed.
Domperidone: There are limited post-marketing data on the use of domperidone in pregnant women. Domperidone should only be used during pregnancy when justified by the anticipated therapeutic benefit. A study in rats has shown reproductive toxicity at a high, maternally toxic dose. The potential risk for humans is unknown.
Use in lactation: Rabeprazole: Following IV administration of 14C-labeled rabeprazole to lactating rats, radioactivity in milk reached levels that were 2- to 7-fold higher than levels in the blood. It is not known if unmetabolized rabeprazole is excreted in human breast milk. Administration of rabeprazole to rats in late gestation and during lactation at doses of 400 mg/kg/day (about 195 times the human dose based on mg/m2) resulted in decreases in body weight gain of the pups. Since many drugs are excreted in milk and because of the potential for adverse reactions to nursing infants from rabeprazole, a decision should be made to discontinue nursing or Rablet-D, taking into account the importance of the drug to the mother.
Domperidone: Domperidone is excreted in breast milk of lactating rats (mostly as metabolites: peak concentration of 40 and 800 ng/mL after oral and IV administration of 2.5 mg/kg, respectively). Domperidone concentrations in breast milk of lactating women are 10-50% of the corresponding plasma concentrations and expected not to exceed 10 ng/mL. The total amount of domperidone excreted in human breast milk is expected to be <7 mcg/day at the highest recommended dosing regimen. It is not known whether this is harmful to the newborn. Therefore, breastfeeding is not recommended for mothers who are taking domperidone.