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 Subutex | Buprenorphine Hydrochloride Tablet and its suitability with breastfeeding.
What is Subutex | Buprenorphine Hydrochloride Tablet used for?
SUBUTEX sublingual tablet is indicated for the treatment of opioid dependence and is preferred for induction. SUBUTEX sublingual tablet 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. SUBUTEX sublingual tablet 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 )
I am currently breastfeeding and I want to know if using Subutex | Buprenorphine Hydrochloride Tablet is safe for my kid? Does it have any effect on milk production?
As per our analysis Subutex | Buprenorphine Hydrochloride 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 Subutex | Buprenorphine Hydrochloride 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
8.3 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 SUBUTEX is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SUBUTEX 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 SUBUTEX 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 5-8 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.
Subutex | 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.
Subutex | 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. The long-term outcome of infants breastfed during maternal buprenorphine therapy for opiate abuse has not been well studied. 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 Subutex | Buprenorphine Hydrochloride Tablet?
As usage of Subutex | 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 Subutex | Buprenorphine Hydrochloride Tablet else no further action is required.
My health care provider has asked me to use Subutex | Buprenorphine Hydrochloride Tablet, what to do?
Usage of Subutex | Buprenorphine Hydrochloride Tablet is safe for nursing mothers and baby, No worries.
If I am using Subutex | Buprenorphine Hydrochloride Tablet, will my baby need extra monitoring?
Who can I talk to if I have questions about usage of Subutex | Buprenorphine Hydrochloride 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