Tramadol Hydrochloride Tablet, Film Coated, Extended Release Breastfeeding
Modern medicine has evolved so much so that sooner or later every breastfeeding mother needs to take it in one form or other. Medication that is present in mothers blood will transfer into her breast milk to some extent. Most drugs do so at low levels and pose no real risk to infants but then there are some exceptions. In This post will discuss whether Tramadol Hydrochloride Tablet, Film Coated, Extended Release is safe in breast-feeding or not.

What is Tramadol Hydrochloride Tablet, Film Coated, Extended Release used for?


Tramadol Hydrochloride Extended-Release Tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see WARNINGS ], reserve Tramadol Hydrochloride Extended-Release Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or immediate-release opioids], are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.

Can I continue breastfeeding if I am using Tramadol Hydrochloride Tablet, Film Coated, Extended Release? How long does it stays in breast milk?

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

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers Risk Summary Tramadol Hydrochloride Extended-Release Tablets are not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied. Tramadol and its metabolite, O-desmethyltramadol (M1), are present in human milk. There is no information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The M1 metabolite is more potent than tramadol in mu opioid receptor binding [see CLINICAL PHARMACOLOGY ] . Published studies have reported tramadol and M1 in colostrum with administration of tramadol to nursing mothers in the early post-partum period. Women who are ultra-rapid metabolizers of tramadol may have higher than expected serum levels of M1, potentially leading to higher levels of M1 in breast milk that can be dangerous in their breastfed infants. In women with normal tramadol metabolism, the amount of tramadol secreted into human milk is low and dose-dependent. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with Tramadol Hydrochloride Extended-Release Tablets. Clinical Considerations Monitor infants exposed to Tramadol Hydrochloride Extended-Release Tablets through breast milk for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. Data Following a single IV 100 mg dose of tramadol, the cumulative excretion in breast milk within 16 hours post dose was 100 mcg of tramadol (0.1% of the maternal dose) and 27 mcg of M1.

Tramadol Hydrochloride Tablet, Film Coated, Extended Release Breastfeeding Analsys


Tramadol hydrochloride while Breastfeeding

Safe

CAS Number: 27203-92-5

Excretion into breast milk is non-significant. No harmful effects on breastfed infants from treated mothers have occurred. Because it is an opium-related medication, a minimal effective dose should be used together with a close follow-up of child's sedation and feeding difficulties.


Tramadol Hydrochloride Tablet, Film Coated, Extended Release Breastfeeding Analsys - 2


Tramadol hydrochloride while Breastfeeding

CAS Number: 27203-92-5

The excretion of tramadol into milk is low and even lower amounts of the active metabolite, O-desmethyltramadol, are excreted. With usual maternal dosage, the amount excreted into breastmilk is much less than the dose that has been given to newborn infants for analgesia. A study of breastfeeding in breastfed newborn infants found no adverse effects attributable to tramadol. Although tramadol is unlikely to adversely affect nursing infant,[1] the U.S. Food and Drug Administration recommends against the use of tramadol during breastfeeding.[2] If tramadol is used, monitor infants for increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties or limpness, and contact a physician immediately if any of these occur.


Is Tramadol Hydrochloride Tablet, Film Coated, Extended Release safe while breastfeeding

I am nursing mother and I have already used Tramadol Hydrochloride Tablet, Film Coated, Extended Release, what should I do?

As usage of Tramadol Hydrochloride 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 Tramadol Hydrochloride Tablet, Film Coated, Extended Release else no further action is required.


My health care provider has asked me to use Tramadol Hydrochloride Tablet, Film Coated, Extended Release, what to do?

Definitely, Tramadol Hydrochloride Tablet, Film Coated, Extended Release is safe in lactation for baby. No wonder your doctor has recommended it.


If I am using Tramadol Hydrochloride Tablet, Film Coated, Extended Release, will my baby need extra monitoring?

No extra baby monitoring required while mother is using Tramadol Hydrochloride Tablet, Film Coated, Extended Release


Who can I talk to if I have questions about usage of Tramadol Hydrochloride Tablet, Film Coated, Extended Release 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