BELBUCA buprenorphine hydrochloride film

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)

थमां उपलब्ध:

Endo Pharmaceuticals, Inc.

INN (इंटरनेशनल नाम):

BUPRENORPHINE HYDROCHLORIDE

रचना:

BUPRENORPHINE 75 ug

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

BELBUCA- BUPRENORPHINE HYDROCHLORIDE FILM
ENDO PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BELBUCA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BELBUCA.
BELBUCA (BUPRENORPHINE) BUCCAL FILM CIII
INITIAL U.S. APPROVAL: 1981
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL EXPOSURE; AND NEONATAL OPIOID WITHDRAWAL SYNDROME; AND
RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
BELBUCA 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, 10)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS ON PROPER
ADMINISTRATION OF BELBUCA TO
REDUCE THE RISK. (5.2)
ACCIDENTAL EXPOSURE TO BELBUCA, ESPECIALLY IN CHILDREN, CAN RESULT IN
FATAL OVERDOSE OF
BUPRENORPHINE. (5.2)
PROLONGED USE OF BELBUCA 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)
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 SEDATION. (5.4, 7)
RECENT MAJOR CHANGES
Boxed Warning 12/2016
Dosage and Administration (2) 12/2016
Warnings and Preca