Butrans

Product manufactured by Purdue Pharma Lp

Application Nr Approved Date Route Status External Links
NDA021306 None Transdermal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Butrans 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. Limitations Of Use Because Of The Risks Of Addiction, Abuse And Misuse With Opioids, Even At Recommended Doses, And Because Of The Greater Risk Of Overdose And Death With Extended-Release Opioid Formulations [See Warnings And Precautions ( 5.1 )] , Reserve Butrans 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. Butrans Is Not Indicated As An As-Needed (Prn) Analgesic Butrans Is A Partial 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 Butrans 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 ) Butrans 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. Buprenorphine BUPRENORPHINE ZINC100373348

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