OPANA ER oxymorphone hydrochloride tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

קנה את זה

הורד מאפייני מוצר (SPC)
04-01-2018

מרכיב פעיל:

OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)

זמין מ:

St Marys Medical Park Pharmacy

INN (שם בינלאומי):

OXYMORPHONE HYDROCHLORIDE

הרכב:

OXYMORPHONE HYDROCHLORIDE 20 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application

מאפייני מוצר

                                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
                                
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