PENTAZOCINE AND NALOXONE hydrochloride tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

PENTAZOCINE HYDROCHLORIDE (UNII: A36BXO4PPX) (PENTAZOCINE - UNII:RP4A60D26L)

Disponibil de la:

PD-Rx Pharmaceuticals, Inc.

INN (nume internaţional):

PENTAZOCINE HYDROCHLORIDE

Compoziție:

PENTAZOCINE 50 mg

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

PENTAZOCINE AND NALOXONE- PENTAZOCINE HYDROCHLORIDE AND NALOXONE
HYDROCHLORIDE TABLET
PD-RX PHARMACEUTICALS, INC.
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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