From the FDA Drug Label
The mean (range) time to reach peak concentration (tmax) was 7. 33 (1 – 24) hours. Due to buprenorphine elimination being faster than absorption from the skin, ZORBIUM exhibits flip-flop pharmacokinetics where the absorption determines its terminal half-life (mean 64.9 hours [range 39.1 – 85.7 hours]).
The time to reach steady state with the Butrans (buprenorphine) patch is not directly stated in the provided text. However, based on the terminal half-life of 64.9 hours, it can be estimated that it may take around 4-5 days to reach steady state, assuming a typical pharmacokinetic profile where steady state is achieved after 4-5 half-lives. However, this is an estimation and not a direct answer from the label. 1
From the Research
Butrans patches (buprenorphine transdermal system) typically take 48 hours to reach steady state blood levels in the body. During this initial period, patients may not experience the full therapeutic effect of the medication. The gradual increase in blood concentration occurs because the patch slowly releases buprenorphine through the skin and into the bloodstream over time. This delayed onset is actually beneficial as it helps minimize side effects that might occur with rapid increases in opioid levels.
Key Points to Consider
- Patients should continue using the patch as prescribed during this initial period and not increase the dose or apply additional patches seeking faster relief.
- The patch is designed to be worn for 7 days before replacement, and steady state levels will be maintained throughout this period once established.
- If pain relief is inadequate during the first few days, healthcare providers may recommend supplemental short-acting pain medication until steady state is achieved.
- This gradual approach to reaching therapeutic levels helps balance pain control with minimizing adverse effects like respiratory depression, nausea, or sedation.
Evidence Supporting the Recommendation
The recommendation is based on the study by 2, which demonstrated that steady-state plasma concentrations of buprenorphine were reached within 48 hours of the first application of the Butrans patch. This study provides the most recent and highest quality evidence for the time to reach steady state with the Butrans patch.
Clinical Implications
The findings of this study have important implications for the management of chronic pain with Butrans patches. By understanding the time to reach steady state, healthcare providers can better counsel patients on what to expect and make informed decisions about adjunctive pain management strategies. Additionally, the study's results highlight the importance of patience and adherence to the prescribed treatment regimen, as the full therapeutic effects of the patch may not be realized until steady state is achieved.