buprenorphine (Buprenex, Subutex, Temgesic, Sublocade, Butrans 'professional man's methadone')

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[1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24]

Introduction

Tradenames: Buprenex, Subutex, Sublocade.

DEA-controlled substance: class 5.

Certification & special DEA # required for prescription.

Drug Addiction Treatment Act (DATA 2000) waiver

(8 hours of training) - if used to treat opiate addiction

No special DEA # required if used to treat chronic pain []

Pharmacists can check if a prescriber has a DATA 2000 waiver because the DEA number will always start with an 'X'.

For prescribers to obtain a DATA 2000 waiver see[8].

For physicians in each state who have DATA 2000 waivers see[9] (list is not always complete)

* The White House recommends providing more training for clinicians to prescribe buprenorphine in states with high levels of misuse.[14]

Indications

* buprenorphine reduces suicide mortality in patients with opiate abuse by 65%[23]

Contraindications

pregnancy category = c

safety in lactation = ?

Dosage

  • pain
    • 0.3 mg IV/IM every 6 hours (Buprenex)
    • 0.2 mg sublingual tablets (Temgesic)
  • opioid addiction
    • doses > 2 mg/day may be needed
    • several years of therapy may be needed
      • < 1 year of therapy associated with higher risk of relapse[22]
    • 4 weeks taper[13]
    • once monthly injection (Sublocade) FDA approved Dec 2018[18]
      • 2 monthly initial doses of 300 mg SQ followed by 100 mg SQ monthly maintenance[18]
      • up to 300 mg SQ monthly may be considered for patients for whom the benefits outweigh the risks[18]
    • 4 80 mg implants every 6 months (24 weeks)[15]

Sublingual: 0.2 mg (Temgesic), 2 mg, 8 mg (Subutex, Suboxone) Implant: 80 mg[15] Sublocade: monthly depot injection[18][20] Butrans: transdermal patch 5, 7.5, 10, 15 & 20 ug/hour weekly[24]

Pharmacokinetics

elimination via liver

Adverse effects

Drug interactions

  • drugs that inhibit cyt P450 3A4 may increase levels of buprenorphine
  • drugs that induce cyt P450 3A4 may diminish levels of buprenorphine

Laboratory

Mechanism of action

Notes

More general terms

More specific terms

Additional terms

Component of

References

  1. ↑ The Pharmacological Basis of Therapeutics, 9th ed. Gilman et al, eds. Permagon Press/McGraw Hill, 1996
  2. ↑ Journal Watch 20(24):193, 2000
  3. ↑ Prescriber's Letter 9(11):65 2002
  4. ↑ Prescriber's Letter 12(9): 2005 Expanded Use of Buprenorphine (Subutex/ Suboxone) for Opioid Dependence Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=211009&pb=PRL (subscription needed) http://www.prescribersletter.com
  5. ↑ Action Report, Medical Board of California, 85:8 (April) 2003
  6. ↑ http://www.buprenorphine.samhsa.gov
  7. ↑ Prescriber's Letter 16(1): 2009 Drugs with Special Prescribing and Dispensing Requirements Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=250101&pb=PRL (subscription needed) http://www.prescribersletter.com
  8. ↑ 8.0 8.1 Drug Addiction Treatment Act (DATA 2000) waiver http://www.suboxone.com/hcp/certification/
  9. ↑ 9.0 9.1 Physicians in each state who have DATA 2000 waivers http://www.buprenorphine.samhsa.gov (866) 287-2728
  10. ↑ Wikipedia: Buprenorphine http://en.wikipedia.org/wiki/Buprenorphine
  11. ↑ 11.0 11.1 Centers for Disease Control and Prevention Buprenorphine Prescribing Practices and Exposures Reported to a Poison Center - Utah, 2002-2011. MMWR. December 14, 2012 / 61(49);997-1001 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6149a1.htm
  12. ↑ Deprecated Reference
  13. ↑ 13.0 13.1 Sigmon SC et al. A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusers. JAMA Psychiatry 2013 Oct 23 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24153411 <Internet> http://archpsyc.jamanetwork.com/article.aspx?articleid=1761270
  14. ↑ 14.0 14.1 14.2 Young K, Fairchild DG, Di Francesco L White House Announces New Measures Aimed at Curbing Opioid Misuse. Physician's First Watch, March 30, 2016 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
    White House Press Release. March 29, 2016 Fact Sheet: Obama Administration Announces Additional Actions to Address the Prescription Opioid Abuse and Heroin Epidemic. https://www.whitehouse.gov/the-press-office/2016/03/29/fact-sheet-obama-administration-announces-additional-actions-address
  15. ↑ 15.0 15.1 15.2 Rosenthal RN, Lofwall MR, Kim S et al Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine. A Randomized Clinical Trial. JAMA. 2016;316(3):282-290 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27434441 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2533504
    Compton WM, Volkow ND Improving Outcomes for Persons With Opioid Use Disorders. Buprenorphine Implants to Improve Adherence and Access to Care. JAMA. 2016;316(3):277-279 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27434440 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2533484
  16. ↑ 16.0 16.1 Stein BD et al. Physician capacity to treat opioid use disorder with buprenorphine-assisted treatment. JAMA 2016 Sep 20; 316:1211. <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27654608 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2553439
  17. ↑ 17.0 17.1 Kraft WK, Adeniyi-Jones SC, Chervoneva I et al Buprenorphine for the Treatment of the Neonatal Abstinence Syndrome. N Engl J Med. May 4, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/28468518 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1614835
  18. ↑ 18.0 18.1 18.2 18.3 18.4 Indivior PLC. Oct 31, 2017 FDA Advisory Committees Recommend Approval of Indivior's RBP-6000 for the Treatment of Opioid Use Disorder. https://www.prnewswire.com/news-releases/fda-advisory-committees-recommend-approval-of-indiviors-rbp-6000-for-the-treatment-of-opioid-use-disorder-300546838.html
    Brooks M FDA Okays Once-Monthly Buprenorphine Shot for Opioid Use Disorder Medscape - Dec 01, 2017. https://www.medscape.com/viewarticle/889462
    FDA News Release. Nov 30, 2017 FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587312.htm
  19. ↑ Martin SA, Chiodo LM, Bosse JD, Wilson A. The next stage of buprenorphine care for opioid use disorder. Ann Intern Med 2018 Oct 23; PMID: https://www.ncbi.nlm.nih.gov/pubmed/30357262
    Hawk K, D'Onofrio G. Time to change the way we approach opioid use disorder: A challenge to the status quo. Ann Intern Med 2018 Oct 23; PMID: https://www.ncbi.nlm.nih.gov/pubmed/30357257
  20. ↑ 20.0 20.1 Haight BR, Learned SM, Laffont CM et al. Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2019 Feb 23;393(10173):778-790 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30792007 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32259-1/fulltext
  21. ↑ 21.0 21.1 NEJM Knowledge+ Internal Medicine Board Review https://myknowledgeplus.nejm.org/flow/flowjs.html
  22. ↑ 22.0 22.1 Williams AR, Samples H, Crystal S, Olfson M. Acute care, prescription opioid use, and overdose following discontinuation of long-term buprenorphine treatment for opioid use disorder. Am J Psychiatry 2019 Dec 2; PMID: https://www.ncbi.nlm.nih.gov/pubmed/31786933 https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.2019.19060612
  23. ↑ 23.0 23.1 Watts BV et al. Association of medication treatment for opioid use disorder with suicide mortality. Am J Psychiatry 2022 Apr; 179:298. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35360916 https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.2021.21070700
    Mooney LJ. Medication treatment for opioid use disorder reduces suicide risk. Am J Psychiatry 2022 Apr; 179:262. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35360917 https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.20220173
  24. ↑ 24.0 24.1 HIGHLIGHTS OF PRESCRIBING INFORMATION Butrans <TM> (buprenorphine) transdermal system, CIII https://app.purduepharma.com/xmlpublishing/pi.aspx?id=b

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