Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
PENTAZOCINE HYDROCHLORIDE (UNII: A36BXO4PPX) (PENTAZOCINE - UNII:RP4A60D26L)
PD-Rx Pharmaceuticals, Inc.
PENTAZOCINE HYDROCHLORIDE
PENTAZOCINE 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
PENTAZOCINE AND NALOXONE- PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE TABLET PD-RX PHARMACEUTICALS, INC. ---------- PENTAZOCINE AND NALOXONE TABLETS PENTAZOCINE AND NALOXONE TABLETS, USP CIV Revised: December 2016 ANALGESIC FOR ORAL USE ONLY WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE PENTAZOCINE AND NALOXONE TABLETS 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 PENTAZOCINE AND NALOXONE TABLETS, 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 PENTAZOCINE AND NALOXONE TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF PENTAZOCINE AND NALOXONE TABLETS OR FOLLOWING A DOSE INCREASE [SEE WARNINGS]. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF PENTAZOCINE AND NALOXONE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF PENTAZOCINE [SEE WARNINGS]. NEONATAL OPIOID WITHDRAWAL SYNDROME PROLONGED USE OF PENTAZOCINE AND NALOXONE TABLETS 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, RESPIRAT read_full_document