Morphine Sulfate 15 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 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 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 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. ( 1 ) • Morphine sulfate extended-release tablets are not indicated as an as-needed (prn) analgesic. ( 1 )
Mylan Pharmaceuticals Inc.
ROUND BLUE MS 15
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16 HOW SUPPLIED/STORAGE AND HANDLING Morphine Sulfate Extended-Release Tablets are available containing 15 mg, 30 mg, 60 mg, 100 mg or 200 mg of morphine sulfate, USP. The 15 mg tablets are light blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 15 on the other side. They are available as follows: NDC 0378-2658-01 bottles of 100 tablets The 30 mg tablets are purple, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 30 on the other side. They are available as follows: NDC 0378-2659-01 bottles of 100 tablets The 60 mg tablets are peach, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 60 on the other side. They are available as follows: NDC 0378-2660-01 bottles of 100 tablets The 100 mg tablets are gray, film-coated, round, unscored tablets debossed with M on one side of the tablet and MS over 100 on the other side. They are available as follows: NDC 0378-2661-01 bottles of 100 tablets The 200 mg tablets are light green, film-coated, oval, unscored tablets debossed with M on one side of the tablet and MS 200 on the other side. They are available as follows: NDC 0378-2662-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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