OPANA oxymorphone hydrochloride tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Bryant Ranch Prepack

INN (שם בינלאומי):

OXYMORPHONE HYDROCHLORIDE

הרכב:

OXYMORPHONE HYDROCHLORIDE 5 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application

מאפייני מוצר

OPANA- OXYMORPHONE HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPANA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OPANA.
OPANA (OXYMORPHONE HYDROCHLORIDE) TABLETS FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1959
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION
WITH
ALCOHOL; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
OPANA EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH
CAN LEAD TO OVERDOSE AND DEATH.
ASSESS PATIENT’S RISK BEFORE PRESCRIBING AND MONITOR REGULARLY FOR
THESE BEHAVIORS AND CONDITIONS.
(5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF OPANA, ESPECIALLY BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF OXYMORPHONE.
(5.2)
PROLONGED USE OF OPANA DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH
MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED. IF PROLONGED
OPIOID USE IS REQUIRED IN A
PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND ENSURE
THAT APPROPRIATE TREATMENT WILL BE AVAILABLE. (5.3)
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCT CONTAINING
ALCOHOL WHILE TAKING OPANA
BECAUSE CO-INGESTION CAN RESULT IN FATAL PLASMA OXYMORPHONE LEVELS.
(5.4)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY
DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING FOR USE IN PATIENTS FOR WHOM ALTERNATIVE
TREATMENT OPTIONS ARE INADEQUATE;
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED; AND FOLLOW
PATIENTS FOR SIGNS AND SYMPTOMS OF
RESPIRATORY DEPRESSION AND SEDAT