Application Nr Approved Date Route Status External Links
NDA200533 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Nucynta Er (Tapentadol) Is 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 Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (Dpn) In Adults 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 Nucynta Er 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. Nucynta Er Is Not Indicated As An As-Needed (Prn) Analgesic. Nucynta Er Is 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 ) Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (Dpn) In Adults 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 Nucynta Er 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. Nucynta Er Is Not Indicated As An As-Needed (Prn) Analgesic. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Tapentadol Hydrochloride TAPENTADOL HYDROCHLORIDE ZINC20783

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