Buprenorphine Tablet Breastfeeding
There are high number of clear evidence that breastfeeding provides best nutrition that you can give to your baby. It is also evident that lactation is good for mothers health as well. Evolution has designed breastfeeding in a way that it caters all nutritional need of your child. However modern medicine is quite new for evolution, that is why mothers body is not well prepared to filter unnecessary chemical found in medicines. It becomes a necessity to figure out which drug is safe and which drug is dangerous for your newborn while nursing. In this article we will understand function of Buprenorphine Tablet and its suitability with breastfeeding.

What is Buprenorphine Tablet used for?

Buprenorphine Sublingual Tablets are indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. Buprenorphine Sublingual Tablets, contain buprenorphine, a partial opioid agonist, and are indicated for the treatment of opioid dependence and is preferred for induction. Prescription use of this product is limited under the Drug Addiction Treatment Act. (1)

Is Buprenorphine Tablet usage safe while breastfeeding? If a lactating mother is using it can there be any effect on growth or development of infant?

Buprenorphine Tablet safe for breastfeeding
As per our analysis Buprenorphine Tablet contains only one ingredient and that is Buprenorphine. We have analyzed Buprenorphine and it seems to be safe to use Buprenorphine while breastfeeding, that means usage of Buprenorphine Tablet shall be safe while breastfeeding. Below you can check more details of Buprenorphine usage in breastfeeding. We recommend you to go through provided detailed analysis as below take decision accordingly.

Statement of Manufacturer/Labeler about breastfeeding usage
8.2 Lactation Risk Summary Based on two studies in 13 lactating women maintained on buprenorphine treatment, buprenorphine and its metabolite norbuprenorphine were present in low levels in human milk and available data have not shown adverse reactions in breastfed infants. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Buprenorphine Sublingual Tablets and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Clinical Considerations Advise breastfeeding women taking buprenorphine products to monitor the infant for increased drowsiness and breathing difficulties. Data Data were consistent from two studies (N=13) of breastfeeding infants whose mothers were maintained on sublingual doses of buprenorphine ranging from 2.4 to 24 mg/day, showing that the infants were exposed to less than 1% of the maternal daily dose. In a study of six lactating women who were taking a median sublingual buprenorphine dose of 0.29 mg/kg/day 5 to 8 days after delivery, breast milk provided a median infant dose of 0.42 mcg/kg/day of buprenorphine and 0.33 mcg/kg/day of norbuprenorphine, equal to 0.2% and 0.12%, respectively, of the maternal weight-adjusted dose (relative dose/kg (%) of norbuprenorphine was calculated from the assumption that buprenorphine and norbuprenorphine are equipotent). Data from a study of seven lactating women who were taking a median sublingual buprenorphine dose of 7 mg/day an average of 1.12 months after delivery indicated that the mean milk concentrations (Cavg) of buprenorphine and norbuprenorphine were 3.65 mcg/L and 1.94 mcg/L respectively. Based on the study data, and assuming milk consumption of 150 mL/kg/day, an exclusively breastfed infant would receive an estimated mean absolute infant dose (AID) of 0.55 mcg/kg/day of buprenorphine and 0.29 mcg/kg/day of norbuprenorphine, or a mean relative infant dose (RID) of 0.38% and 0.18%, respectively, of the maternal weight-adjusted dose.

Buprenorphine Tablet Breastfeeding Analsys

Buprenorphine while Breastfeeding


CAS Number: 52485-79-7

It is a semi-synthetic opioid which is used to replace Methadone in the treatment of opioid addiction. Mothers on Buprenorphine showed a shorter mean hospital stay than those who were treated with Methadone. The amount of dose reaching the infant is minimal and has no untoward side effects. It has been noticed a mild and transient abstinence syndrome after birth when sudden withdrawn occurred. Addiction to narcotic drugs and the use of substitutive treatments lowers the breastfeeding rate and duration of nursing.

Buprenorphine Tablet Breastfeeding Analsys - 2

Buprenorphine while Breastfeeding

CAS Number: 52485-79-7

Because of the low levels of buprenorphine in breastmilk, its poor oral bioavailability in infants, and the low drug concentrations found in the serum and urine of breastfed infants, its use is acceptable in nursing mothers. Monitor the infant for drowsiness, respiratory depression, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants. Although unlikely, if the baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, a physician should be contacted immediately. Observe infants for withdrawal signs if breastfeeding is stopped abruptly. Women who received buprenorphine for opiate abuse during pregnancy and are stable should be encouraged to breastfeed their infants postpartum, unless there is another contraindication, such as use of street drugs.[1][2][3][4][5][6][7][8][9][10] The long-term outcome of infants breastfed during maternal buprenorphine therapy for opiate abuse has not been well studied.[11] The breastfeeding rate among mothers taking buprenorphine for opiate dependency may be lower than in other mothers.

What should I do if I am breastfeeding mother and I am already exposed to Buprenorphine Tablet?

Buprenorphine Tablet is safe in breastfeeding and should not create any health problem for your baby but in case you feel any health issue associated with Buprenorphine Tablet you should contact your doctor or health care provider. Be it pregnancy or lactation you shall keep your doctor informed.

I am nursing mother and my doctor has suggested me to use Buprenorphine Tablet, is it safe?

Usage of Buprenorphine Tablet is safe for nursing mothers and baby, No worries.

If I am using Buprenorphine Tablet, will my baby need extra monitoring?


Who can I talk to if I have questions about usage of Buprenorphine Tablet 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