Budesonide Tablet, Extended Release while Breastfeeding

Modern medicine has evolved so much so that sooner or later every breastfeeding mother needs to take it in one form or other. Medication that is present in mothers blood will transfer into her breast milk to some extent. Most drugs do so at low levels and pose no real risk to infants but then there are some exceptions. In This post will discuss whether Budesonide Tablet, Extended Release is safe in breast-feeding or not.

Budesonide extended release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Budesonide extended release tablets are a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. (1)

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers The disposition of budesonide when delivered by inhalation from a dry powder inhaler at doses of 200 or 400 mcg twice daily for at least 3 months was studied in eight lactating women with asthma from 1 to 6 months postpartum.1 Systemic exposure to budesonide in these women appears to be comparable to that in non-lactating women with asthma from other studies. Breast milk obtained over 8 hours post-dose revealed that the maximum budesonide concentration for the 400 and 800 mcg total daily doses was 0.39 and 0.78 nmol/L, respectively, and occurred within 45 minutes after inhalation. The estimated oral daily dose of budesonide from breast milk to the infant is approximately 0.007 and 0.014 mcg/kg/day for the two-dose regimens used in this study, which represents approximately 0.3% to 1% of the dose inhaled by the mother. Budesonide plasma concentrations obtained from five infants at about 90 minutes after breastfeeding (and about 140 minutes after drug administration to the mother) were below quantifiable levels (<0.02 nmol/L in four infants and <0.04 nmol/L in one infant). The recommended daily dose of budesonide extended release tablets is higher (9 mg daily) compared with inhaled budesonide (up to 800 mcg daily) given to mothers in the above study. The maximum budesonide plasma concentration following a 9 mg daily dose (in both single- and repeated-dose pharmacokinetic studies) of oral budesonide is approximately 5-10 nmol/L which is up to 10 times higher than the 1-2 nmol/L for a 800 mcg daily dose of inhaled budesonide at steady state in the above inhalation study. Since there are no data from controlled trials on the use of budesonide extended release tablets by nursing mothers or their infants, and because of the potential for serious adverse reactions in nursing infants from budesonide extended release tablets, a decision should be made whether to discontinue nursing or to discontinue budesonide extended release tablets, taking into account the clinical importance of budesonide extended release tablets to the mother. Budesonide is secreted in human milk. Data from budesonide delivered via dry powder inhaler indicates that the total daily oral dose of budesonide available in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother. Assuming the coefficient of extrapolation between the inhaled and oral doses is constant across all dose levels, at therapeutic doses of budesonide extended release tablets, budesonide exposure to the nursing child may be up to 10 times higher than that by budesonide inhalation.