Fentanyl (Transdermal System Patch) 75mcg/h is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.
Limitations Of Use
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve DURAGESIC for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
DOSAGE AND ADMINISTRATION
DURAGESIC should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
Due to the risk of respiratory depression, DURAGESIC is only indicated for use in patients who are already opioid-tolerant. Discontinue or taper all other extended-release opioids when beginning DURAGESIC therapy. As DURAGESIC is only for use in opioid-tolerant patients, do not begin any patient on DURAGESIC as the first opioid.
Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Initiate the dosing regimen for each patient individually, taking into account the patient’s prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [seeWARNINGS AND PRECAUTIONS]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with DURAGESIC when serum concentrations from the initial patch will peak [see WARNINGS AND PRECAUTIONS].
The recommended starting dose when converting from other opioids to DURAGESIC is intended to minimize the potential for overdosing patients with the first dose.
Discontinue all other around-the-clock opioid drugs when DURAGESIC therapy is initiated.
While there are useful tables of opioid equivalents readily available, there is substantial interpatient variability in the relative potency of different opioid drugs and products. As such, it is preferable to underestimate a patient’s 24-hour fentanyl requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour fentanyl requirements which could result in adverse reactions. In a DURAGESIC clinical trial, patients were converted from their prior opioid to DURAGESIC using Table 1 as a guide for the initial DURAGESIC dose.
Consider the following when using the information in Table 1:
- This is not a table of equianalgesic doses.
- The conversion doses in this table are only for the conversion from one of the listed oral or parenteral opioid analgesics to DURAGESIC.
- The table cannot be used to convert from DURAGESIC to another opioid. Doing so will result in an overestimation of the dose of the new opioid and may result in fatal overdose.