BUPRENEX- buprenorphine hydrochloride injection

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

buprenorphine hydrochloride (UNII: 56W8MW3EN1) (buprenorphine - UNII:40D3SCR4GZ)

Inapatikana kutoka:

Indivior Inc.

INN (Jina la Kimataifa):

buprenorphine hydrochloride

Tungo:

buprenorphine 0.3 mg in 1 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

BUPRENEX is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS: Addiction, Abuse, and Misuse] reserve BUPRENEX 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. BUPRENEX is contraindicated in patients with: - Significant respiratory depression [See WARNINGS]. - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [See WARNINGS]. - Known or suspected gastrointestinal obstruction, including paralytic ileus [See WARNINGS]. - Hypersensitivity to buprenorphine (e.g. anaphylaxis) or any other ingredient in BUPRENEX [See WARNINGS]. BUPRENEX contains buprenor

Bidhaa muhtasari:

BUPRENEX (buprenorphine hydrochloride) is supplied in cartons containing five clear glass snap-ampules of 0.3 mg/mL buprenorphine). NDC 12496-0757-5 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [USP Controlled Room Temperature]. Protect from prolonged exposure to light. Manufactured by: Reckitt Benckiser Healthcare (UK) Ltd., Hull, England, HU8 7DS Distributed by: Indivior Inc., North Chesterfield, VA 23235 Revised June 2022

Idhini hali ya:

New Drug Application

Tabia za bidhaa

BUPRENEX- BUPRENORPHINE HYDROCHLORIDE INJECTION
INDIVIOR INC.
----------
CIII
NDC 12496-0757-5
BUPRENEX ® (buprenorphine hydrochloride) injection, for intravenous
or intramuscular
administration, CIII
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL
SYNDROME AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
BUPRENEX EXPOSES PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID
ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH.
ASSESS EACH PATIENT'S RISK PRIOR TO PRESCRIBING BUPRENEX, AND MONITOR
ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND
CONDITIONS (SEE WARNINGS).
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF BUPRENEX. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING
INITIATION OF BUPRENEX OR FOLLOWING A DOSE INCREASE (SEE WARNINGS).
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF BUPRENEX DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT
RECOGNIZED AND TREATED, AND REQUIRES MANAGEMENT ACCORDING TO
PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF OPIOID USE IS REQUIRED
FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE
RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT
APPROPRIATE
TREATMENT WILL BE AVAILABLE (SEE WARNINGS).
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
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 (SEE
WARNINGS, PRECAUTIONS).
RESERVE CONCOMITANT PRESCRIBING OF BUPRENEX AND BENZODIAZEPINES
OR OTHER CNS DEPRESSANTS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE
TREATMENT OPTIONS ARE INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS
FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION.
DE