oxymorphone hydrochloride tablet film coated extended release
1 INDICATIONS AND USAGE Oxymorphone Hydrochloride 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. Oxymorphone Hydrochloride 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. ( 1 ) 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, reserve Oxymorphone Hydrochloride 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 ) Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic. ( 1 ) Limitations of Usage: 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 Oxymorphone Hydrochloride 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. Oxymorphone Hydrochloride Extended-Release Tablets are not indicated as an as-needed (prn) analgesic.
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ROUND GREEN G73
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16 HOW SUPPLIED/STORAGE AND HANDLING
OXYMORPHONE HYDROCHLORIDE Extended-Release Tablets, USP are supplied as follows: 5 mg purple, round, film-coated extended-release tablets debossed with "G71" on one side and blank on the other side. Bottles of 30 NDC 0115-1231-08 Bottles of 60 NDC 0115-1231-13 Bottles of 100 NDC 0115-1231-01 Bottles of 1,000 NDC 0115-1231-03 7.5 mg gray, round, film-coated extended-release tablets debossed with "G75" on one side and blank on the other side. Bottles of 30 NDC 0115-1315-08 Bottles of 60 NDC 0115-1315-13 Bottles of 100 NDC 0115-1315-01 Bottles of 1,000 NDC 0115-1315-03 10 mg orange, round, film-coated extended-release tablets debossed with "G72" on one side and blank on the other side. Bottles of 30 NDC 0115-1232-08 Bottles of 60 NDC 0115-1232-13 Bottles of 100 NDC 0115-1232-01 Bottles of 1,000 NDC 0115-1232-03 15 mg white, round, film-coated extended-release tablets debossed with "G76" on one side and blank on the other side. Bottles of 30 NDC 0115-1316-08 Bottles of 60 NDC 0115-1316-13 Bottles of 100 NDC 0115-1316-01 Bottles of 1,000 NDC 0115-1316-03 20 mg green, round, film-coated extended-release tablets debossed with "G73" on one side and blank on the other side. Bottles of 30 NDC 0115-1233-08 Bottles of 60 NDC 0115-1233-13 Bottles of 100 NDC 0115-1233-01 Bottles of 1,000 NDC 0115-1233-03 30 mg brown, round, film-coated extended-release tablets debossed with "G77" on one side and blank on the other side. Bottles of 30 NDC 0115-1317-08 Bottles of 60 NDC 0115-1317-13 Bottles of 100 NDC 0115-1317-01 Bottles of 1,000 NDC 0115-1317-03 40 mg orange, round, film-coated extended-release tablets debossed with "G74" on one side and blank on the other side. Bottles of 30 NDC 0115-1234-08 Bottles of 60 NDC 0115-1234-13 Bottles of 100 NDC 0115-1234-01 Bottles of 1,000 NDC 0115-1234-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). Store
OXYMORPHONE HYDROCHLORIDE Extended-Release Tablets securely and dispose of properly [see Patient Counseling Information (17) ] .
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