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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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