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buprenorphine/naloxone (Bunavail, Suboxone)

Combination of buprenorphine plus naloxone. DEA-controlled substance: class 5. Certification & special DEA # required for prescription. Prescribers must get a Drug Addiction Treatment Act (DATA 2000) waiver to become certified to prescribe Suboxone for office-based treatment of opioid dependence. This involves completion of an approved eight hour CME course & notification of the government of the intent to use Suboxone or Subutex to treat opioid-dependent patients. 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 [2] Indications: - treatment of opiate abuse & opioid dependence (opioid maintenance therapy) Dosage: - 2 mg & 8 mg (of buprenorphine) sublingual - sublingual film* can be cut for dose tapering [4] - mucoadhesive buccal film (Bunavail) * requires opiate washout so as not to precipitate withdrawal [8] * FDA has approved first generic versions of sublingual film [7]

General

pharmacologic combination

References

  1. Prescriber's Letter 9(11):65 2002
  2. Drug Addiction Treatment Act (DATA 2000) waiver http://www.suboxone.com/hcp/certification/
  3. Wikipedia: Buprenorphine http://en.wikipedia.org/wiki/Buprenorphine
  4. Prescriber's Letter 18(1): 2011 New Formulation: Suboxone Sublingual Film Detail-Document#: 270109 (subscription needed) http://www.prescribersletter.com
  5. biodelivery. June 6m 2014 First and Only FDA-Approved Buccal Film Formulation of Buprenorphine and Naloxone to Compete in the $1.7 Billion and Growing U.S. Opioid Dependence Market. http://bdsi.investorroom.com/2014-06-06-BioDelivery-Sciences-Receives-FDA-Approval-for-BUNAVAIL-buprenorphine-and-naloxone-Buccal-Film-for-the-Maintenance-Treatment-of-Opioid-Dependence
  6. Brooks M FDA OKs Bunavail for Induction of Opioid Addiction Treatment. Medscape - May 02, 2017. http://www.medscape.com/viewarticle/879399
  7. Brooks M FDA Clears First Generic Versions of Suboxone Sublingual Film Medscape - Jun 14, 2018. https://www.medscape.com/viewarticle/898114 - FDA News Release. June 14, 2018 FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610807.htm
  8. VA Southern Oregon Rehabilitation Center and Clinics SORCC 8495 Crater Lake Highway White City, OR 97503

Components

buprenorphine (Buprenex, Subutex, Temgesic, Sublocade, Butrans 'professional man's methadone') naloxone (Narcan, Evzio, ReVive)