Buprenorphine Hydrochloride Tablet 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 Buprenorphine Hydrochloride Tablet is safe for baby while breastfed.

What is Buprenorphine Hydrochloride Tablet used for?


Buprenorphine Sublingual Tablets is 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 physicians 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 is 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)

Buprenorphine Hydrochloride Tablet while breastfeeding safe or not? Can there be any side effects for infant while using it during breastfeeding?

Buprenorphine Hydrochloride Tablet safe for breastfeeding
Buprenorphine is the only one ingredient used in manufacturing of Buprenorphine Hydrochloride Tablet, Which makes it easier to analyze its effect in breastfeeding. As per our analysis of Buprenorphine it is safe to use Buprenorphine Hydrochloride Tablet while lactating. We suggest you to check further details below about Buprenorphine usage in breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Risk Summary Based on two studies in 13 lactating women, buprenorphine and its metabolite norbuprenorphine are present in low levels in human milk and infant urine, and available data have not shown adverse reactions in breastfed infants. There are no data on the combination product buprenorphine/naloxone in breastfeeding, however oral absorption of naloxone is minimal. Caution should be exercised when buprenorphine is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for buprenorphine and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. Clinical Considerations Advise the nursing mother taking buprenorphine to monitor the infant for increased drowsiness and breathing difficulties. Data Based on limited data from a study of 6 lactating women who were taking a median oral dose of buprenorphine of 0.29 mg/kg/day 5 to 8 days after delivery, breast milk contained a median infant dose of 0.42 mcg/kg/day of buprenorphine and 0.33 mcg/kg/day of norbuprenorphine, which are equal to 0.2% and 0.12% of the maternal weight-adjusted dose. Based on limited data from a study of 7 lactating women who were taking a median oral dose of buprenorphine of 7 mg/day an average of 1.12 months after delivery, the mean milk concentrations of buprenorphine and norbuprenorphine were 3.65 mcg/L and 1.94 mcg/L respectively. Based on the limited data from this study, and assuming milk consumption of 150 mL/kg/day, an exclusively breastfed infant would receive an estimated mean of 0.55 mcg/kg/day of buprenorphine and 0.29 mcg/kg/day of norbuprenorphine, which are 0.38% and 0.18% of the maternal weight-adjusted dose. No adverse reactions were observed in the infants in these two studies. Females and Males of Reproductive Potential Infertility Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2)].

Buprenorphine Hydrochloride Tablet Breastfeeding Analsys


Buprenorphine while Breastfeeding

Safe

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 Hydrochloride 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 already breastfed my kid after using Buprenorphine Hydrochloride Tablet?

As usage of Buprenorphine Hydrochloride Tablet 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 Buprenorphine Hydrochloride Tablet else no further action is required.


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

Definitely, Buprenorphine Hydrochloride Tablet is safe in lactation for baby. No wonder your doctor has recommended it.


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

No extra baby monitoring required while mother is using Buprenorphine Hydrochloride Tablet


Who can I talk to if I have questions about usage of Buprenorphine Hydrochloride Tablet in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
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

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week

Drug Brands with same Active ingredients

Buprenorphine Patch
Buprenorphine Hcl Tablet
Probuphine | Buprenorphine Hydrochloride Implant
Sublocade | Buprenorphine Solution
Belbuca | Buprenorphine Hydrochloride Film, Soluble
Butrans | Buprenorphine Patch, Extended Release
Buprenex | Buprenorphine Hydrochloride Injection