Entocort Ec | Budesonide Capsule while Breastfeeding

Breast milk is superior in nutrition, It provides resistance against infections and allergies, It is naturally sterile. Despite all the advantages of breastfeeding some mothers choose to pause the breastfeeding in fear of harmful effects of medicines passing in breast milk. Are you wondering about breastfeeding and using Entocort Ec | Budesonide Capsule ? Know what is Entocort Ec | Budesonide Capsule and how it can affect your breast milk and whether Entocort Ec | Budesonide Capsule is safe for your kid or not.

ENTOCORT EC is indicated for the treatment of mild to moderate active Crohn's disease involving the iluem and/or the ascending colon and 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.

Statement of Manufacturer/Labeler about breastfeeding usage
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 eight 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 breast feeding (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 ENTOCORT EC capsules is higher (up to 9 mg daily) compared with inhaled budesonide (up to 800 μg 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 μg 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 ENTOCORT EC by nursing mothers or their infants, and because of the potential for serious adverse reactions in nursing infants from ENTOCORT EC, a decision should be made whether to discontinue nursing or to discontinue ENTOCORT EC, taking into account the clinical importance of ENTOCORT EC to the mother. Budesonide, like other corticosteroids, 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 ENTOCORT EC, budesonide exposure to the nursing child may be up to 10 times higher than that by budesonide inhalation.