Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1) (BUPRENORPHINE - UNII:40D3SCR4GZ)
Par Pharmaceutical, Inc.
BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE 0.324 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS: Addiction, Abuse, and Misuse] reserve buprenorphine 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 been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Buprenorphine hydrochloride is contraindicated in patients with: - Significant respiratory depression [See WARNINGS]. Significant respiratory depression [See WARNINGS]. - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [See WARNINGS]. Acute or severe bronchial asthma i
Buprenorphine Hydrochloride Injection NDC 42023-179-05: 0.3 mg buprenorphine in a 1 mL single dose clear glass vial, supplied in packages of five vials. Store at 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.) Protect from prolonged exposure to light. The vial stopper is not made with natural rubber latex.
Abbreviated New Drug Application
BUPRENORPHINE HYDROCHLORIDE- BUPRENORPHINE HYDROCHLORIDE INJECTION PAR PHARMACEUTICAL, INC. ---------- BUPRENORPHINE HYDROCHLORIDE INJECTION 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 BUPRENORPHINE 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 BUPRENORPHINE, 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 BUPRENORPHINE. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF BUPRENORPHINE OR FOLLOWING A DOSE INCREASE (SEE WARNINGS). NEONATAL OPIOID WITHDRAWAL SYNDROME PROLONGED USE OF BUPRENORPHINE 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 BUPRENORPHINE 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. DESCRIPTION Buprenorphine hy Կարդացեք ամբողջական փաստաթուղթը