Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet while Breastfeeding
What is Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet ?
Can I use Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet while breastfeeding?
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 and Naloxone Sublingual Tablets are 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 naloxone 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 and Naloxone Sublingual Tablets 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 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 And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet Breastfeeding Analsys
Buprenorphine while Breastfeeding
SafeCAS 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.
Naloxone while Breastfeeding
Low RiskCAS Number: 357-08-4
Antagonist of opium derivative drugs.
Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone 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.
Naloxone while Breastfeeding
CAS Number: 465-65-6
No information is available on the excretion of naloxone into breastmilk. Because it is not orally bioavailable, it is unlikely to affect the breastfed infant. However, if naloxone is required by the mother for an opiate overdose, she should withhold nursing until the opiate is out of her system.
What if I already have used Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet?
Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet is in the category of low risk, if you have already used it then its not a big deal if health and behavior of baby is good. However your health care provider shall be aware of the fact that you have used Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet so you should inform him based on your convenience.
My doctor has prescribed me Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet, what should I do?
Though Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.
If I am using Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet, will my baby need extra monitoring?
Not much monitoring required while using Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone Hydrochloride Tablet
Who can I talk to if I have questions about usage of Buprenorphine And Naloxone | Buprenorphine Hydrochloride And Naloxone 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