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Tramadol Pregnancy and Breastfeeding Warnings

Tramadol is also known as: ConZip, GenRx Tramadol, Larapam SR, Rybix, Rybix ODT, Ryzolt, Tramadol Hydrochloride ER, Tramahexal, Tramahexal SR, Tramal, Tramal SR, Tramedo, Ultram, Ultram ER, Ultram ODT, Zamadol, Zydol, Zydol XL

Tramadol Pregnancy Warnings

Use is not recommended AU TGA pregnancy category: C US FDA pregnancy category: Not Assigned Comments: -Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.

Tramadol has been shown to cross the placental barrier, with an umbilical vein to maternal vein serum concentration ratio of 0.83. Animal studies have shown at very high doses, this drug has an effect on organ development, bone growth, and mortality rate. Prolonged maternal use of opioid analgesics during pregnancy may result in respiratory depression and physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. There have been postmarketing reports of neonatal seizures, neonatal withdrawal syndrome, fetal death, and still births. There are no adequate and well-controlled studies in pregnant women. Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Tramadol Breastfeeding Warnings

Serious adverse reactions in breastfed infants may include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death. Newborns have limited capacity to metabolize the active 0-desmethyltramadol. A study in 75 mothers reported an average milk concentration of 748 mcg/L; this translates to an average infant dose of 112 mcg/kg and a maternal weight-adjusted dose of 2.24% and 0.64% for the drug and its metabolite, respectively. Reanalysis of the data using a population pharmacokinetic model showed a maternal weight adjusted dose of 2.2% for extensive metabolizers and 2.6% for poor metabolizers. The amount of drug present in breast milk represents a maximum of 2.6% of the proposed IV newborn dose. This drug can increase prolactin levels; however, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Use is not recommended Excreted into human milk: Yes Comments: -The US FDA recommends against the use of tramadol during breastfeeding due to risks of serious adverse reactions in breastfed infants. -Discontinuation of breastfeeding following a single dose of this drug is generally not necessary; if used, the infant should be monitored for increased sleepiness, difficulty breastfeeding, breathing difficulties or limpness.

See references

References for pregnancy information

  1. "Product Information. Ultram (tramadol)." McNeil Pharmaceutical, Raritan, NJ.
  2. "Product Information. Ultram ER (traMADol)." PriCara Pharmaceuticals, Raritan, NJ.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Ultram ER (traMADol)." PriCara Pharmaceuticals, Raritan, NJ.
  2. US Food and Drug Administration (FDA) "FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. Available from: URL: https://www.fda.gov/Drugs/DrugSafety/ucm549679.h" ([2017, Apr 20]):
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. "Product Information. Ultram (tramadol)." McNeil Pharmaceutical, Raritan, NJ.

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