Titration and maintenance of Schedule III, 7-day Butrans
5 dosage strengths assist with dose titration.
- Butrans is for transdermal use (on intact skin) only
- Each Butrans patch is intended to be worn for 7 days
- Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc prolongation
- Butrans doses of 7.5, 10, 15 and 20 mcg/hour are only for use in patients who are opioid experienced and in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid-experienced are those receiving, for one week or longer, daily opioid doses up to 80 mg/day of oral morphine or an equianalgesic dose of another opioid
Titration and maintenance of Butrans therapy
- Individually titrate Butrans to a dose that provides adequate analgesia and minimizes adverse reactions
- Continually reevaluate patients receiving Butrans to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse or misuse
- Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration
- During chronic therapy, periodically reassess the continued need for opioid analgesics
- Because steady-state plasma concentrations are achieved within 72 hours, the Butrans dose may be adjusted every 3 days
- The maximum Butrans dose is 20 mcg/hour. Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation
- In a clinical trial, Butrans 40 mcg/hour (given as 2 Butrans 20 mcg/hour systems) resulted in prolongation of the QTc interval
Patients who experience breakthrough pain may require dosage adjustment increase of Butrans, or may need rescue medication with an appropriate dose of an immediate-release analgesic (opioid or non-opioid)
- If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the Butrans dose
- If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage
- Adjust the dose to obtain an appropriate balance between the management of pain and opioid-related adverse reactions
