Do you know that important immune protective proteins are present in breast milk? Breast milk also contains required vitamins, minerals, saturated and un saturated fats. These things are extremely important for development of healthy brain. If you are taking any medicine for short term or for the chronic reason then that passes in breast milk as well, that is why you should always check the drug with your health care provider. Here at DrLact we try to analyze drugs based on available researches and in this sheet we will present our analysis for Budesonide Tablet, Film Coated, Extended Release.
What is Budesonide Tablet, Film Coated, Extended Release used for?
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)
Is using Budesonide Tablet, Film Coated, Extended Release unsafe in breastfeeding? Can there be bad consequences for baby if I use it while breastfeeding?
Active ingredient in Budesonide Tablet, Film Coated, Extended Release is Budesonide and based on our analysis of Budesonide it appears that using Budesonide Tablet, Film Coated, Extended Release is safe in breastfeeding. Below is analysis of Budesonide while breastfeeding.
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 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 (less than 0.02 nmol/L in four infants and less than 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 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. 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.
Budesonide Tablet, Film Coated, Extended Release Breastfeeding Analsys
Budesonide while Breastfeeding Safe
Non-significant levels of drug in the milk are found. The infant is further protected because of a low oral bioavailability. Most expert's opinion is that topical, oral or inhaled steroid medication is compatible with breastfeeding,
Budesonide Tablet, Film Coated, Extended Release Breastfeeding Analsys - 2
Budesonide while Breastfeeding
CAS Number: 51333-22-3
The amounts of inhaled budesonide excreted into breastmilk are minute and infant exposure is negligible. When taken by mouth, budesonide is only about 9% bioavailable; bioavailability in the infant is likely to be similarly low for any budesonide that enters the breastmilk. Most experts consider oral and inhaled corticosteroids, including budesonide, acceptable to use during breastfeeding.
I already used Budesonide Tablet, Film Coated, Extended Release and meanwhile I breastfed my baby should I be concerned?
As usage of Budesonide Tablet, Film Coated, Extended Release is mostly safe while breastfeeding hence there should not be any concern. In case of any change in behavior or health of your baby you should inform your health care provider about usage of Budesonide Tablet, Film Coated, Extended Release else no further action is required.
My health care provider has asked me to use Budesonide Tablet, Film Coated, Extended Release, what to do?
Usage of Budesonide Tablet, Film Coated, Extended Release is safe for nursing mothers and baby, No worries.
If I am using Budesonide Tablet, Film Coated, Extended Release, will my baby need extra monitoring?
Who can I talk to if I have questions about usage of Budesonide Tablet, Film Coated, Extended Release in breastfeeding?
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week