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Use in Pregnancy: Tablet: Teratogenic Effects: Pregnancy Category B: Reproduction studies have been performed in pregnant rats at oral doses up to 40 times the recommended human dose and in pregnant rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to lansoprazole.
There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Prevacid should be used during pregnancy only if clearly needed.
IV: PREVACID I.V. should be used in pregnant women or women having possibilities of being pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk. (In animal studies [rats, oral dose], higher plasma concentration of lansoprazole in the fetus than in the mother animal was observed. In pregnant rabbits [oral doses of 30 mg/kg/day], an increased fetus death rate was observed.)
Use in lactation: Tablet: Lansoprazole or its metabolites are excreted in the milk of rats. It is not known whether lansoprazole is excreted in human milk. Because many drugs are excreted in human milk, because of the potential for serious adverse reactions in nursing infants from lansoprazole and because of the potential for tumorigenicity shown for lansoprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
IV: It is advisable to avoid the administration of PREVACID I.V. to nursing mothers. However, when the administration is indispensable, nursing should be discontinued. (It has been reported in animal studies [rats, oral dose] that lansoprazole is transferred to mother's milk).
