Budesonide nasal Pregnancy and Breastfeeding Warnings
Budesonide nasal Pregnancy Warnings
Budesonide has been assigned to pregnancy category B by the FDA. At high doses given subcutaneously, budesonide has been shown to be teratogenic in rabbits and rats. Budesonide has not been shown to be teratogenic in animals when given in high doses by inhalation. The impact of budesonide on human pregnancy has been evaluated through assessments of birth registries linked with maternal usage of intranasally administered budesonide. The results from population-based prospective cohort epidemiological studies reviewing data from three Swedish registries from 1995-2001 indicate no increased risk for overall congenital malformations from the use of intranasal budesonide during early pregnancy. Budesonide is only recommended for use during pregnancy when benefit outweighs risk.
Budesonide nasal Breastfeeding Warnings
There are no data on the excretion of budesonide into human milk. Other glucocorticoids are excreted into human milk in low concentrations. The manufacturer recommends that caution be used when administering budesonide nasal to nursing women.
Budesonide, like other corticosteroids, is secreted in human milk. Data with budesonide delivered orally via dry powder inhaler to women with asthma indicates that the total daily oral dose of budesonide in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother. No studies have been conducted in breastfeeding women specifically with budesonide nasal; however, the dose of budesonide available to the infant in breast milk, as a percentage of the maternal dose, would be expected to be similar. Budesonide nasal should be used in nursing women only if clinically appropriate. Prescribers should weigh the known benefits of breastfeeding for the mother and infant against the potential risks of minimal budesonide exposure in the infant. Dosing considerations include prescription or titration to the lowest clinically effective dose and use of budesonide nasal immediately after breastfeeding to maximize the time interval between dosing and breastfeeding to minimize infant exposure. However, in general, budesonide nasal use should not delay or interfere with infant feeding.
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