Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)
St Marys Medical Park Pharmacy
OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE 20 mg
PRESCRIPTION DRUG
New Drug Application
OPANA ER - OXYMORPHONE HYDROCHLORIDE TABLET ST MARYS MEDICAL PARK PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION OPANA ER 20 MG THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OPANA® ER SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OPANA® ER. OPANA® ER (OXYMORPHONE HYDROCHLORIDE) EXTENDED-RELEASE TABLETS, CII INITIAL U.S. APPROVAL: 1959 WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. - OPANA ER CONTAINS OXYMORPHONE WHICH IS AN OPIOID AGONIST AND A SCHEDULE II CONTROLLED SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO OTHER OPIOID ANALGESICS. (9) - OXYMORPHONE CAN BE ABUSED IN A MANNER SIMILAR TO OTHER OPIOID AGONISTS, LEGAL OR ILLICIT. THIS SHOULD BE CONSIDERED WHEN PRESCRIBING OR DISPENSING OPANA ER IN SITUATIONS WHERE THE PHYSICIAN OR PHARMACIST IS CONCERNED ABOUT AN INCREASED RISK OF MISUSE, ABUSE, OR DIVERSION. (9) - OPANA ER IS NOT INTENDED FOR USE AS AN AS NEEDED ANALGESIC. (1) - OPANA ER TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, DISSOLVED, OR CRUSHED AS THIS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYMORPHONE. (2) - PATIENTS MUST NOT CONSUME ALCOHOLIC BEVERAGES, PRESCRIPTION OR NON-PRESCRIPTION MEDICATIONS CONTAINING ALCOHOL. CO-INGESTION OF ALCOHOL WITH OPANA ER MAY RESULT IN A POTENTIALLY FATAL OVERDOSE OF OXYMORPHONE. (2) INDICATIONS AND USAGE INDICATIONS AND USAGE - OPANA ER is an opioid agonist indicated for the relief of moderate to severe pain in patients requiring continuous around- the-clock opioid treatment for an extended period of time. (1) - Not intended for use as an as needed analgesic. Not indicated in the immediate post-operative period or if the pain is mild or not expected to persist for an extended period of time. (1) DOSAGE AND ADMINISTRATION DOSAGE AND ADMINISTRATION - Administered on an empty stomach, at least 1 hour prior to or 2 hours after eating. (2.2) - Symmetrical, every 12h do Lugege kogu dokumenti