morphine sulfate tablet extended release
1 INDICATIONS AND USAGE Morphine sulfate extended-release tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions ( 5.1 )], reserve morphine sulfate extended-release tablets 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 tablets are not indicated as an as-needed (prn) analgesic. Morphine sulfate extended-release tablets are an opioid agonist indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations, reserve morphine sulfate extended-release tablets 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 tablets are not indicated as an as-needed (prn) analgesic.
Mallinckrodt, Inc.
ROUND BLUE M 15
M 15 ROUND BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE Extended-Release Tablets are supplied as follows: 15 mg - round, blue convex tablet, debossed on one side and debossed “15” on the other. Bottles of 100 ................................. NDC 0406-8315-01 Unit Dose (10 x 10)......................... NDC 0406-8315-62 30 mg - round, purple convex tablet, debossed on one side and debossed “30” on the other. Bottles of 100 ................................. NDC 0406-8330-01 Unit Dose (10 x 10)......................... NDC 0406-8330-62 60 mg - round, orange convex tablet, debossed on one side and debossed “60” on the other. Bottles of 100 ................................. NDC 0406-8380-01 Unit Dose (10 x 10)......................... NDC 0406-8380-62 100 mg - round, gray convex tablet, debossed on one side and debossed “100” on the other. Bottles of 100 ................................. NDC 0406-8390-01 Unit Dose (10 x 10)......................... NDC 0406-8390-62 200 mg - capsule-shaped, green convex tablet, debossed on one side and debossed “200” on the other. Bottles of 100 ................................. NDC 0406-8320-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store
MORPHINE SULFATE extended-release tablets securely and dispose of properly [see Patient Counseling Information (17) ] . Dispense in a tight, light-resistant container. Boxed M Boxed M Boxed M Boxed M Boxed M
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