Application Nr Approved Date Route Status External Links
NDA020616 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Morphine Sulfate Extended-Release Capsules 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 Morphine Sulfate Extended-Release Capsules 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. Morphine Sulfate Extended-Release Capsules Are Not Indicated As An As-Needed (Prn) Analgesic. Morphine Sulfate Extended-Release Capsules 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. 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 ( 5.1 ), Reserve Morphine Sulfate Extended-Release Capsules 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. Morphine Sulfate Extended-Release Capsules Are Not Indicated As An As-Needed (Prn) Analgesic.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Morphine Sulfate MORPHINE SULFATE ZINC3812983

Comments