From the FDA Drug Label
The use of Buprenorphine Sublingual Tablets for unsupervised administration should be limited to those patients who cannot tolerate buprenorphine sublingual film or buprenorphine sublingual tablet; for example, those patients who have been shown to be hypersensitive to naloxone.
Patients Dependent on Methadone or Other Long-acting Opioid Products: Patients dependent upon methadone or other long-acting opioid products may be more susceptible to precipitated and prolonged withdrawal during induction than those on short-acting opioid products; therefore, the first dose of Buprenorphine Sublingual Tablets should only be administered when objective and clear signs of moderate opioid withdrawal appear, and generally not less than 24 hours after the patient last used a long-acting opioid product.
The recommended approach for converting a patient from Butrans (buprenorphine) to Suboxone (buprenorphine with naloxone) is not directly addressed in the provided drug labels. However, it is essential to consider the type of opioid dependence, the time since last opioid use, and the degree of opioid dependence when initiating treatment with buprenorphine.
- Key considerations:
- Patients dependent on long-acting opioid products like Butrans may be more susceptible to precipitated and prolonged withdrawal during induction.
- The first dose of buprenorphine should only be administered when objective and clear signs of moderate opioid withdrawal appear.
- For patients on long-acting opioids, the first dose of buprenorphine should generally not be given less than 24 hours after the last use of the long-acting opioid. Given the lack of direct information on converting from Butrans to Suboxone, a conservative approach would be to:
- Monitor the patient closely for signs of withdrawal and adjust the dosing schedule accordingly.
- Consult the prescribing information for both Butrans and Suboxone for guidance on dosing and administration.
- Consider seeking expert advice from a qualified healthcare professional with experience in opioid dependence treatment. 1 1
From the Research
When converting a patient from Butrans (transdermal buprenorphine) to Suboxone (sublingual buprenorphine/naloxone), the recommended approach is to discontinue the Butrans patch and wait 12-24 hours before initiating Suboxone, as this allows for a gradual transition and minimizes the risk of precipitated withdrawal 2.
Key Considerations
- Patients should be in mild to moderate withdrawal before starting Suboxone, typically scoring at least 5-6 on the Clinical Opiate Withdrawal Scale (COWS) 3.
- For patients on Butrans 5-10 mcg/hr, start with Suboxone 2/0.5 mg to 4/1 mg; for those on Butrans 15-20 mcg/hr, begin with Suboxone 4/1 mg to 8/2 mg 3.
- Titrate the Suboxone dose over several days based on withdrawal symptoms and cravings, typically to a target of 8/2 mg to 16/4 mg daily 2.
- Monitor patients closely during this transition period for withdrawal symptoms, cravings, and side effects 4.
Rationale
The transition from Butrans to Suboxone requires careful consideration of the pharmacokinetics and pharmacodynamics of both medications. Buprenorphine, the active ingredient in both medications, has a high affinity for opioid receptors, but its partial agonist properties can precipitate withdrawal in patients who are physically dependent on full agonist opioids 5. The use of a transdermal bridge, such as Butrans, can facilitate a smoother transition by providing a steady state of buprenorphine in the body 3. However, the transition to Suboxone, which contains naloxone, requires careful titration to avoid precipitated withdrawal 2.
Clinical Implications
The recommended approach prioritizes minimizing the risk of precipitated withdrawal and ensuring a smooth transition from Butrans to Suboxone. Clinicians should closely monitor patients during this transition period and adjust the Suboxone dose as needed to manage withdrawal symptoms and cravings 4. By following this approach, clinicians can optimize the transition from Butrans to Suboxone and improve patient outcomes in terms of morbidity, mortality, and quality of life.