morphine sulfate 60 mg
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. 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 ) 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.
mayne pharma inc.
ROUND ORANGE ML 60
ML 60 ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
MORPHINE SULFATE extended-release 15 mg tablets are round, film-coated, blue tablets, debossed with "15" on one side and "ML" on the other side. They are available as follows: NDC 51862-185-01 bottles of 100
MORPHINE SULFATE extended-release 30 mg tablets are round, film-coated, purple tablets, debossed with "30" on one side and "ML" on the other side. They are available as follows: NDC 51862-186-01 bottles of 100
MORPHINE SULFATE extended-release 60 mg tablets are round, film-coated, orange tablets, debossed with "60" on one side and "ML" on the other side. They are available as follows: NDC 51862-187-01 bottles of 100
MORPHINE SULFATE extended-release 100 mg tablets are round, film-coated, gray tablets, debossed with "100" on one side and "ML" on the other side. They are available as follows: NDC 51862-188-01 bottles of 100 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 as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. CAUTION DEA FORM REQUIRED
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