其 他 安 全 警 示
|
| |
| Canada: Important safety information on SUBOXONE (buprenorphine and naloxone) and the risk of overdose or underdose when switching between dosage forms or routes of administration (English only) |
| |
Health Canada announces that it has authorized two 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.
Both dosage forms are used for substitution treatment in adults with problematic opioid drug dependence. SUBOXONE soluble film may be administered sublingually (for both induction and maintenance therapy) or buccally (for maintenance therapy). SUBOXONE sublingual tablet can only be administered sublingually.
In several pharmacokinetic studies following the administration of different dosages, a dose of one or two 2 mg/0.5 mg SUBOXONE films administered sublingually or buccally showed comparable buprenorphine and naloxone bioavailability to the same total dose of SUBOXONE tablets. In contrast, one 8 mg/2 mg and one 12 mg/3 mg SUBOXONE film administered sublingually or buccally showed higher relative bioavailability for both buprenorphine and naloxone compared to the same total dose of SUBOXONE tablets. A combination of one 8 mg/2 mg and two 2 mg/0.5 mg SUBOXONE films (total dose of 12 mg/3 mg) administered sublingually showed comparable buprenorphine and naloxone bioavailability to the same total dose of SUBOXONE tablets, while buccally administered SUBOXONE film showed higher relative bioavailability.
Healthcare professionals should be aware of the following when switching patients between SUBOXONE soluble film and SUBOXONE sublingual tablet:
- Patients being switched between the tablet and the film should be started on the same dosage of the previously administered product. When switching between the tablet and film, patients should be monitored in case there is a need to adjust the dose.
- When switching from tablet to film, the film should initially be administered sublingually. Patients who are stabilized on sublingually-administered film can be switched to buccally-administered film.
- Due to the greater bioavailability of the film compared to the tablet at certain strengths, patients switching from tablet to film should be monitored for symptoms of overdose. Those switching from film to tablet should be monitored for symptoms of underdose, including opioid withdrawal.
- Combining or alternating between film and tablet dosage forms is not advised.
Healthcare professionals should be aware of the following when switching patients between sublingual and buccal sites of administration with SUBOXONE soluble film:
- For induction, the film should only be administered sublingually.
- Once induction with the film is complete (typically within 2 days), patients can be switched between sublingual to buccal administration without significant risk of overdosing or underdosing. This is because the systemic exposure of buprenorphine between buccal and sublingual administration of the film is similar.
- Patients should be monitored when switching between the two routes of administration.
The Canadian Product Monograph for SUBOXONE contains the recommendations outlined in this communication.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74719a-eng.php
In Hong Kong, Suboxone Sublingual Tab 8mg/2mg (HK-56197) and Suboxone Sublingual Tab 2mg/0.5mg (HK-56198) are registered pharmaceutical products containing buprenorphine/naloxone. Both products are registered by Zuellig Pharma Ltd, and are prescription-only medicines. As only one dosage form of Suboxone is registered (i.e. the sublingual tablet administered only sublingually), the risk of overdose or underdose when switching between dosage forms or routes of administration mentioned in the above Health Canada’s announcement has no impact in Hong Kong.
Ends/Friday, Jan 8, 2021
Issued at HKT 18:00
|
| |
