Budesonide Capsule, Gelatin Coated while Breastfeeding

It is a well known fact that breastfeeding is best source of nutrition for infants. Breast milk provides minerals, vitamins and antibodies in most acceptable format when they need it. Nutrition taken by mother passes to breast-milk and same thing applies to medicines taken by mothers. Not all drugs cause problem for baby but some do. Lets analyze if Budesonide Capsule, Gelatin Coated is safe for baby while breastfed.

Budesonide capsules are a corticosteroid indicated for: Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. (1.1) Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. (1.2) 1.1 Treatment of Mild to Moderate Active Crohn’s Disease Budesonide capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. Pediatric use information is approv ed for Perrigo Pharma International DAC’s ENTOCORT EC (budesonide) capsules. However, due to Perrigo Pharma International DAC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease Budesonide capsules are indicated for the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.

Statement of Manufacturer/Labeler about breastfeeding usage
8.2 Lactation Risk Summary Lactation studies have not been conducted with oral budesonide, including budesonide, and no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. One published study reports that budesonide is present in human milk following maternal inhalation of budesonide [see Data]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for budesonide and any potential adverse effects on the breastfed infant from budesonide, or from the underlying maternal condition. Data One published study reports that budesonide is present in human milk following maternal inhalation of budesonide which resulted in infant doses approximately 0.3% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.4 and 0.5. Budesonide plasma concentrations were not detected and no adverse events were noted in the breastfed infants following maternal use of inhaled budesonide. The recommended daily dose of budesonide capsules is higher (up to 9 mg daily) compared with inhaled budesonide (up to 800 mcg daily) given to mothers in the above described 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 to 10 nmol/L which is up to 10 times higher than the 1 to 2 nmol/L for a 800 mcg daily dose of inhaled budesonide at steady-state in the above inhalation study. Assuming the coefficient of extrapolation between the inhaled and oral doses is constant across all dose levels, at therapeutic doses of budesonide, budesonide exposure to the nursing child may be up to 10 times higher than that by budesonide inhalation.