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Health Canada Health products

Important Safety Information on SUBOXONE (buprenorphine and naloxone) and the Risk of Overdose or Underdose when Switching Between Dosage Forms or Routes of Administration

Issued January 7, 2021
Issue
Health Canada has authorized 2 dosage forms of SUBOXONE (buprenorphine and naloxone), a sublingual tablet and soluble film, that are not bioequivalent at all doses and routes of administration. Switching between dosage forms or routes of administration could result in variations in buprenorphine or naloxone blood plasma concentrations, which could lead to inadvertent overdosing or underdosing, including opioid withdrawal.
Hazard description
Product safety