Return to Home Ensuring Appropriate Use Educating Patients Resources for Healthcare Professionals

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)
SUBOXONE® (buprenorphine and naloxone) Sublingual Tablet (CIII)
SUBUTEX® (buprenorphine) Tablet (CIII)

Prescribers

Prescribers play an important role in reducing the risks of accidental overdose, misuse, and abuse, associated with buprenorphine-containing transmucosal products. To help mitigate these risks, prescribers should:

  • Verify the patient meets appropriate diagnostic criteria.
  • Discuss the risks (including misuse and abuse) and side effects associated with buprenorphine-containing products, including those described in the Medication Guide. (See the brochure, Office-Based Buprenorphine Therapy for Opioid Dependence: Important Information for Prescribers for additional safety information regarding these risks.)
  • Explain what patients should do if they experience side effects.
  • Provide induction doses under appropriate supervision.
  • Prescribe a limited amount of medication to the patient that will last until the next visit.
  • Explain how to safely store the medication out of the reach of children.
  • Schedule patient appointments commensurate with patient stability (weekly or more frequent visits recommended for the first month).
  • Consider "pill/film count"/dose reconciliation.
  • Assess:
    • whether patient is receiving counseling/psychosocial support considered necessary for treatment and if not, encourage them to do so.
    • whether patient is making progress toward treatment goals (including, as appropriate, urine toxicology testing).
    • the appropriateness of the maintenance dose.
    • whether or not benefits of treatment outweigh the risks.

To prescribe products covered under the SUBOXONE Film, SUBOXONE Tablets, and SUBUTEX Tablets REMS, a prescriber must be certified to treat opioid dependence under the Drug Addiction Treatment Act of 2000 (DATA 2000). For certification information, click here.


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