Omeprazole / sodium bicarbonate Pregnancy and Breastfeeding Warnings
Omeprazole / sodium bicarbonate Pregnancy Warnings
In rabbits, omeprazole in a dose range of 6.9 to 69 mg/kg/day (about 2.8 to 28 times the human dose of 40 mg/day, based on body surface area (BSA)) produced dose-related increases in embryolethality, fetal resorptions and pregnancy disruptions. In rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 2.8 to 28 times the human dose of 40 mg/day, based on BSA).
Omeprazole-sodium bicarbonate has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy. Some animal studies using omeprazole have revealed evidence of embryolethality and fetotoxicity. Some experts consider the use of sodium bicarbonate as an antacid during human pregnancy to be relatively contraindicated because of the availability of preferable therapeutic agents. Omeprazole-sodium bicarbonate is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Omeprazole / sodium bicarbonate Breastfeeding Warnings
The peak concentration of omeprazole in breast milk following an oral dose of 20 mg was less than 7% of the mother's peak serum concentration. The concentration was calculated to be 0.004 mg of omeprazole in 200 mL of milk.
Omeprazole is excreted into human milk. There are no data on the excretion of sodium bicarbonate into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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