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1 Indications And Usage Tramadol Hydrochloride Extended-Release Tablets Are Indicated For The Management Of Pain Severe Enough To Require Daily, Around-The-Clock, Long-Term Opioid Treatment And For Which Alternative Treatment Options Are Inadequate. 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 [See Warnings And Precautions (5.1) ] , Reserve Tramadol Hydrochloride Extended-Release Tablets 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. • Tramadol Hydrochloride Extended-Release Tablets Are Not Indicated As An As-Needed (Prn) Analgesic. Tramadol Hydrochloride Extended-Release Tablets Are An Opioid Agonist Indicated For The Management Of Pain Severe Enough To Require Daily Around-The-Clock, Long-Term Opioid Treatment And For Which Alternative Treatment Options Are Inadequate. ( 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 Tramadol Hydrochloride Extended-Release Tablets 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 ) • Tramadol Hydrochloride Extended-Release Tablets Are Not Indicated As An As-Needed (Prn) Analgesic. ( 1 )
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