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Famotidine / ibuprofen Pregnancy and Breastfeeding Warnings

Famotidine / ibuprofen is also known as: Duexis

Famotidine / ibuprofen Pregnancy Warnings

Famotidine-ibuprofen has been assigned to pregnancy category C by the FDA. Ibuprofen by itself has been assigned to pregnancy category C prior to 30 weeks gestation and pregnancy category D at greater than or equal to 30 weeks gestation. Animal reproduction studies have not been conducted with famotidine-ibuprofen. Reproductive studies conducted with famotidine in rats and rabbits at oral doses of up to 243 times the recommended human dose and at IV doses of up to 200 mg/kg/day, have revealed no significant evidence of impaired fertility or harm to the fetus. Reproductive studies conducted with ibuprofen in rats and rabbits have not demonstrated evidence of developmental abnormalities; however, because of the known effects of NSAIDs on the fetal cardiovascular system (premature closure of ductus arteriosus) and possible prolongation of labor and delivery, use of ibuprofen starting at 30 weeks gestation should be avoided. Famotidine-ibuprofen should be used during pregnancy when benefit outweighs risk and avoided at greater than or equal to 30 weeks gestation.

Famotidine / ibuprofen Breastfeeding Warnings

Famotidine is excreted in the milk of lactating rats. Transient growth depression was observed in nursing rats from mothers treated with doses at least 300 times the usual human dose. Famotidine is detectable in human milk. It is not known whether ibuprofen is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from famotidine-ibuprofen, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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