buprenorphine/naloxone (Bunavail, Suboxone)
Introduction
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]
More general terms
Components
- buprenorphine (Buprenex, Subutex, Temgesic, Sublocade, Butrans 'professional man's methadone')
- naloxone (Narcan, Evzio, ReVive)
References
- ↑ Prescriber's Letter 9(11):65 2002
- ↑ 2.0 2.1 Drug Addiction Treatment Act (DATA 2000) waiver http://www.suboxone.com/hcp/certification/
- ↑ Wikipedia: Buprenorphine http://en.wikipedia.org/wiki/Buprenorphine
- ↑ 4.0 4.1 Prescriber's Letter 18(1): 2011 New Formulation: Suboxone Sublingual Film Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=270109&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 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
- ↑ Brooks M FDA OKs Bunavail for Induction of Opioid Addiction Treatment. Medscape - May 02, 2017. http://www.medscape.com/viewarticle/879399
- ↑ 7.0 7.1 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 - ↑ 8.0 8.1 VA Southern Oregon Rehabilitation Center and Clinics SORCC 8495 Crater Lake Highway White City, OR 97503