Morphine Sulfate 100 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Morphine sulfate extended-release tablets 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 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 is 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. ( 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 morphine sulfate extended-release 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 ) Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. ( 1 )
actavis pharma, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE extended-release tablets are available as follows: 15 mg Each round, white to off white, film-coated, unscored tablet debossed with on one side and 270 on the other side contains 15 mg of
MORPHINE SULFATE, USP. Tablets are supplied in bottles of 100 (NDC 0228-4270-11). 30 mg Each round, yellow, film-coated, unscored tablet debossed with on one side and 271 on the other side contains 30 mg of
MORPHINE SULFATE, USP. Tablets are supplied in bottles of 100 (NDC 0228-4271-11). 60 mg Each round, pink, film-coated, unscored tablet debossed with on one side and 311 on the other side contains 60 mg of
MORPHINE SULFATE, USP. Tablets are supplied in bottles of 100 (NDC 0228-4311-11). 100 mg Each round, red, film-coated, unscored tablet debossed with on one side and 323 on the other side contains 100 mg of
MORPHINE SULFATE, USP. Tablets are supplied in bottles of 100 (NDC 0228-4323-11). 200 mg Each capsule-shaped, red, film-coated, unscored tablet debossed with on one side and 347 on the other side contains 200 mg of
MORPHINE SULFATE, USP. Tablets are supplied in bottles of 100 (NDC 0228-4347-11). Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°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 as defined in the USP. logo logo logo logo logo
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