Rablet-I should be used during pregnancy only if the potential benefit justifies the probable risks involved. In view of likelihood of rabeprazole to be excreted in human milk and because of potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or Rablet-I, taking into account the importance of therapy to the mother.
Use in pregnancy: Rabeprazole: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Rablet-I should be used during pregnancy only if clearly needed.
Itopride: The safety of Rablet-I in pregnant women has not been established. Therefore, Rablet-I should only be used in pregnant women or women suspected being pregnant, provided that the expected therapeutic benefits are evaluated to outweigh the possible risk of treatment. No teratogenic effects have been detected in animals.
Use in lactation: Rabeprazole: 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 discontinue the drug, taking into account the importance of the drug to the mother.
Itopride: Itopride hydrochloride is excreted with the breast milk in lactating rats. Treatment with itopride should be avoided during breastfeeding.
Use in children: Safety and efficacy of Rablet-I ingredients in children have not been established.