tramadol (Ultram)

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Introduction

Tradename: Ultram. DEA class 4 agent as of Aug 18, 2014.

Indications

* minimal benefit with significant adverse effects in treatment of knee osteoarthritis or hip osteoarthritis[25]

* no fewer serious adverse effects than oxcodone or hydrocodone for treatment of postoperative pain after hip arthroplasty or knee arthroplasty[27]

Contraindications

pregnancy category = c

safety in lactation = -

Dosage

  • immediate release
    • 50-100 mg PO every 4-6 hours, max 400 mg/day
    • elderly (< 75 years): 50 mg every 6 hours, max 300 mg/day
  • extended release
    • QD dosing, maximum 300 mg/day
    • use with caution in the elderly

Tabs: (immediate release) 50 mg

Tabs: (extended release) 100, 200, 300 mg

Dosage adjustment in renal failure

Pharmacokinetics

elimination via liver

elimination via kidney

Adverse effects

Drug interactions

Laboratory

  • Therapeutic range: 100-300 ng/mL (monitoring not required)

Mechanism of action

More general terms

Additional terms

Component of

References

  1. Drugdex Drug Evaluation
  2. Geriatric Dosage Handbook, 6th edition, Selma et al eds, Lexi-Comp, Cleveland, 2001
  3. 3.0 3.1 Medications Can Cause Seizures Prescriber's Letter 10(3):16 2003 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=190320&pb=PRL (subscription needed) http://www.prescribersletter.com
  4. 4.0 4.1 Department of Veterans Affairs, VA National Formulary
  5. 5.0 5.1 Prescriber's Letter 15(12): 2008 Common Oral Medications that May Need Tapering Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=241208&pb=PRL (subscription needed) http://www.prescribersletter.com
  6. Lexi-Comp, Inc 2009
  7. 7.0 7.1 7.2 FDA MedWatch Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm213264.htm
  8. 8.0 8.1 Prescriber's Letter 17(7): 2010 New Abuse and Safety Warnings for Tramadol Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260711&pb=PRL (subscription needed) http://www.prescribersletter.com
  9. Prescriber's Letter 19(3): 2012 Drug Interactions with Tramadol Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=280310&pb=PRL (subscription needed) http://www.prescribersletter.com
  10. 10.0 10.1 Deprecated Reference
  11. 11.0 11.1 11.2 11.3 Geriatric Review Syllabus, 8th edition (GRS8) Durso SC and Sullivan GN (eds) American Geriatrics Society, 2013
    Geriatric Review Syllabus, 11th edition (GRS11) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2022
  12. Prescriber's Letter 21(8): 2014 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=300827&pb=PRL (subscription needed) http://www.prescribersletter.com
  13. 13.0 13.1 13.2 Fournier JP et al Tramadol Use and the Risk of Hospitalization for Hypoglycemia in Patients With Noncancer Pain. JAMA Intern Med. Published online December 08, 2014 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25485799 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=1984249
    Nelson LS, Juurlink DN Tramadol and HypoglycemiaOne More Thing to Worry About. JAMA Intern Med. Published online December 08, 2014. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25486516 <Internet> http://archinte.jamanetwork.com/article.aspx?articleid=1984243
  14. 14.0 14.1 14.2 FDA Safety Alert Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm463499.htm
  15. 15.0 15.1 Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015
  16. 16.0 16.1 Paauw DS Dangerous and Deadly Drug Combinations Medscape. June 30, 2016 http://www.medscape.com/features/slideshow/dangerous-drug-combinations
  17. 17.0 17.1 17.2 FDA Safety Alert. 04/20/2017 Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554029.htm
  18. 18.0 18.1 Dunn KE, Tompkins A, Bigelow GE et al Efficacy of Tramadol Extended-Release for Opioid Withdrawal. A Randomized Clinical Trial. JAMA Psychiatry. Published online July 12, 2017. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28700791 <Internet> http://jamanetwork.com/journals/jamapsychiatry/fullarticle/2642924
  19. 19.0 19.1 Zeng C, Dubreuil M, LaRochelle MR et al Association of Tramadol With All-Cause Mortality Among Patients With Osteoarthritis. JAMA. 2019;321(10):969-982. PMID: https://www.ncbi.nlm.nih.gov/pubmed/30860559 https://jamanetwork.com/journals/jama/article-abstract/2727448
  20. 20.0 20.1 Geriatric Review Syllabus, 10th edition (GRS10) Harper GM, Lyons WL, Potter JF (eds) American Geriatrics Society, 2019
  21. 21.0 21.1 Thiels CA, Habermann EB, Hooten WM, Jeffery MM. Chronic use of tramadol after acute pain episode: Cohort study. BMJ 2019 May 14; 365:l1849 PMID: https://www.ncbi.nlm.nih.gov/pubmed/31088782 Free PMC Article https://www.bmj.com/content/365/bmj.l1849
  22. 22.0 22.1 22.2 Xie J, Strauss VY, Martinez-Laguna D et al Association of Tramadol vs Codeine Prescription Dispensation With Mortality and Other Adverse Clinical Outcomes. JAMA. 2021;326(15):1504-1515 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34665205 https://jamanetwork.com/journals/jama/fullarticle/2785265
  23. 23.0 23.1 Hassamal S, Miotto K, Dale W et al. Tramadol: understanding the risk of serotonin syndrome and seizures. Am J Med. 2018;131(11):1382.e1-1382.e6. PMID: https://www.ncbi.nlm.nih.gov/pubmed/29752906 https://www.amjmed.com/article/S0002-9343(18)30402-9/fulltext
  24. tramadol (Rx) Classes: Opioid Analgesics https://reference.medscape.com/drug/ultram-conzip-tramadol-343324
  25. 25.0 25.1 Zhang X et al. Efficacy and safety of tramadol for knee or hip osteoarthritis: A systematic review and network meta-analysis of randomized controlled trials. Arthritis Care Res (Hoboken) 2023 Jan; 75:158. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34251756 https://onlinelibrary.wiley.com/doi/10.1002/acr.24750
  26. NEJM Knowledge+ Pain Management and Opioids: Recharge
    Beakley BD, Kaye AM, Kaye AD. Tramadol, Pharmacology, Side Effects, and Serotonin Syndrome: A Review. Pain Physician. 2015 Jul-Aug;18(4):395-400. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26218943 Free article. Review.
  27. 27.0 27.1 Bosco E, Riester MR, Beaudoin FL et al Comparative Safety of Tramadol and Other Opioids Following Total Hip and Knee Arthroplasty. BMC Geriatr. 2024 Apr 5;24(1):319 PMID: https://www.ncbi.nlm.nih.gov/pubmed/38580920 PMCID: PMC10996118 Free PMC article

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