MS CONTIN
Details
- Status
- Prescription
- First Approved
- 1987-05-29
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
MS CONTIN Approval History
What MS CONTIN Treats
1 indicationsMS CONTIN is approved for 1 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
MS CONTIN Boxed Warning
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MS CONTIN Addiction, Abuse, and Misuse Because the use of MS CONTIN exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warning and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respirato...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MS CONTIN Addiction, Abuse, and Misuse Because the use of MS CONTIN exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warning and Precautions (5.1) ]. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of MS CONTIN, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of MS CONTIN are essential. Instruct patients to swallow MS CONTIN tablets whole; crushing, chewing, or dissolving MS CONTIN tablets can cause rapid release and absorption of a potentially fatal dose of morphine. [see Warnings and Precautions (5.2) ]. Accidental Ingestion Accidental ingestion of even one dose of MS CONTIN, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions (5.2) ]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of MS CONTIN and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ]. Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4) ]. Opioid Analgesic Risk Evaluation and Mitigation
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MS CONTIN FDA Label Details
ProIndications & Usage
FDA Label (PDF)MS CONTIN is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ] , reserve opioid analgesics, including MS CONTIN, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide suffi...
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF MS CONTIN Addiction, Abuse, and Misuse Because the use of MS CONTIN exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.