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1 Indications And Usage Fentanyl Transdermal System 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 Morphine Per Day, 25 Mcg Transdermal Fentanyl Per Hour, 30 Mg Oral Oxycodone Per Day, 8 Mg Oral Hydromorphone Per Day, 25 Mg Oral Oxymorphone Per Day, 60 Mg Oral Hydrocodone Per Day, 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/long-Acting Opioid Formulations [see Warnings And Precautions (5.1) ] , Reserve Fentanyl Transdermal System 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. Fentanyl Transdermal System Is Not Indicated As An As-Needed (prn) Analgesic. Fentanyl Transdermal System Contains Fentanyl, An Opioid Agonist, And 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. ( 1 ) Patients Considered Opioid-Tolerant Are Those Taking, For One Week Or Longer, At Least 60 Mg Oral Morphine Per Day, 25 Mcg Transdermal Fentanyl Per Hour, 30 Mg Oral Oxycodone Per Day, 8 Mg Oral Hydromorphone Per Day, 25 Mg Oral Oxymorphone Per Day, 60 Mg Oral Hydrocodone Per Day, Or An Equianalgesic Dose Of Another Opioid. ( 2.1 ) 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 Fentanyl Transdermal System 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. ( 1 ) Fentanyl Transdermal System Is Not Indicated As An As-Needed (prn) Analgesic.
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