morphine sulfate
Drug Details
- Generic Name
- morphine sulfate
- Brand Names
- Morphine Sulfate, Morphine sulfate, INFUMORPH 500, Duramorph, MS Contin, INFUMORPH 200
- Application Number
- ANDA203158
- Sponsor
- Nortec Development Associates, Inc.
- NDC Codes
- 35
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET, FILM COATED, EXTENDED RELEASE, TABLET, INJECTION, SOLUTION, INJECTION, SOLUTION
- Routes
- ORAL, EPIDURAL, INTRATHECAL, INTRAVENOUS
- Active Ingredients
- MORPHINE SULFATE
Indications and Usage
1 INDICATIONS AND USAGE Morphine sulfate suppositories are indicated for the management of acute and chronic pain severe enough to require and opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve morphine sulfate suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia Morphine sulfate suppositories is an opioid agonist indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve morphine sulfate suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesia