Opana 10 MG Oral Tablet
1 INDICATIONS AND USAGE OPANA is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions ( 5.1 ) ], reserve OPANA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia OPANA is an opioid agonist indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OPANA for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia
Endo Pharmaceuticals
ROUND RED E613 10
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16 HOW SUPPLIED/STORAGE AND HANDLING OPANA (oxymorphone hydrochloride) tablets are supplied as follows: 5 mg Tablet: blue, round, convex tablets debossed with E612 over 5 on one side and plain on the other. Bottles of 100 tablets with child-resistant closure NDC 63481-612-70 Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-612-75 10 mg Tablet: red, round, convex tablets debossed with E613 over 10 on one side and plain on the other. Bottles of 100 tablets with child-resistant closure NDC 63481-613-70 Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only) NDC 63481-613-75 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). Store OPANA Tablets securely and dispose of properly [ see Patient Counseling Information ( 17 ) ].
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