Tramadol
CASRN: 27203-92-5
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Drug Levels and Effects:
Summary of Use during Lactation:
Tramadol produces low levels in milk and a study in breastfed newborn infants found no adverse effects attributable to tramadol. Tramadol is unlikely to adversely affect healthy, full-term infants and acceptable to use during breastfeeding. However, monitor premature infants for increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties or limpness, and contact a physician immediately if any of these occur.
Drug Levels:
In adults, tramadol has 70 to 100% oral bioavailability and is metabolized to the active O-desmethyltramadol. The half-life of tramadol in newborns is about 7 hours while that of the active metabolite is about 8.5 hours.[1]
Maternal Levels. Detectable levels (>12 mcg/L) of tramadol were found in samples of breastmilk collected 10 hours after a 50 mg maternal dose of intravenous or oral tramadol.[2] No other clinical details or milk levels were reported.
Seventy-five mothers who were 2 to 4 days postpartum provided 3 milk samples from both breasts during the 6 hours following a dose of 100 mg of oral tramadol after taking at least 4 doses. The average milk concentration of tramadol was 748 mcg/L (range 681 to 815 mcg/L) and of its metabolite, O-desmethyltramadol, was 203 mcg/L (range 188 to 217 mcg/L). These values translate to an average infant dosage of 112 and 30 mcg/kg daily of the drug and metabolite, respectively, or about 14% of the therapeutic dose for a child. An exclusively breastfed infant would receive maternal weight-adjusted dosages of 2.24% of tramadol and 0.64% of its metabolite.[1]
One mother was taking oral tramadol 1800 mg daily during pregnancy and postpartum for chronic back pain. On approximately day 3 postpartum (time not specified), the breastmilk concentration of tramadol was 1.8 mg/L.
[3]
Infant Levels. An infant was born to a mother who as taking 1800 mg of tramadol daily for chronic back pain. By day 3, the infant was exclusively breastfeeding and a serum concentration was obtained (time not specified). The infant's tramadol serum concentration was 2 mcg/L.[3]
Effects in Breastfed Infants:
One woman received alglucerase 30 international units/kg intravenously every 2 weeks during pregnancy and lactation. Her breastfed infant reportedly grew and developed normally.[5]
A woman received imiglucerase 30 units/kg every 2 weeks during pregnancy and for 3 months while breastfeeding. The dose was then increased to 60 units/kg every 2 weeks because of disease progression, and she continued breastfeeding until the infant was 1 year old.[6]
A woman receiving long-term therapy with imiglucerase 60 units/kg intravenously every 2 weeks became pregnant twice during therapy and breastfed both infants (extent not stated). Both infants developed normally during the observation periods of 13 and 33 months.[4]
Possible Effects on Lactation:
Tramadol can increase serum prolactin.[3] However, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Alternate Drugs to Consider:
Acetaminophen, Ibuprofen, Morphine
References:
1. Ilett KF, Paech MJ, Page-Sharp M et al. Use of a sparse sampling study design to assess transfer of tramadol and its o-desmethyl metabolite into transitional breast milk. Br J Clin Pharmacol. 2008;65:661-6. PMID: 18294329
2. Kmetec V, Roskar R. HPLC determination of tramadol in human breast milk. J Pharm Biomed Anal. 2003;32:1061-6. PMID: 12899994
3. Hartenstein S, Proquitte H, Bauer S et al. Neonatal abstinence syndrome (NAS) after intrauterine exposure to tramadol. J Perinat Med. 2010;38:695-6. PMID: 20707626
4. Seitz W, Kirchner E, Schaps D, Wagner T, Hesch RD. [Endocrine reaction pattern in the course of a one-phase tramadol-N2O combination anesthesia]. Anasth Intensivther Notfallmed. 1982;17:325-31. PMID: 6297329
Substance Identification:
Substance Name: Tramadol
CAS Registry Number: 27203-92-5
Drug Class:
Analgesics, Opioid
Narcotics
Administrative Information:
LactMed Record Number:
391
Last Revision Date:
20110104
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