OXYCODONE AND ACETAMINOPHEN solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)

Available from:

Mallinckrodt, Inc.

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 5 mg in 5 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN SOLUTION
MALLINCKRODT, INC.
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OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION
(5 MG/325 MG PER 5 ML)
RX ONLY
CII
REVISED: DECEMBER 2016
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE;
LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
NEONATAL OPIOID WITHDRAWAL SYNDROME, CYTOCHROME P450 3A4
INTERACTION; HEPATOTOXICITY, AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
RISK OF MEDICATION ERRORS
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
OXYCODONE
HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION. DOSING ERRORS DUE TO
CONFUSION BETWEEN
MG AND ML, AND OTHER OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
SOLUTIONS OF DIFFERENT
CONCENTRATIONS CAN RESULT IN ACCIDENTAL OVERDOSE AND DEATH (_SEE
_WARNINGS, DOSAGE
AND ADMINISTRATION).
ADDICTION, ABUSE, AND MISUSE
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION 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 OXYCODONE
HYDROCHLORIDE AND
ACETAMINOPHEN ORAL SOLUTION, 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 OXYCODONE
HYDROCHLORIDE AND ACETAMINOPHEN ORAL SOLUTION. MONITOR FOR RESPIRATORY
DEPRESSION,
ESPECIALLY DURING INITIATION OF OXYCODONE HYDROCHLORIDE AND
ACETAMINOPHEN ORAL SOLUTION OR
FOLLOWING A DOSE INCREASE (_SEE _WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL
SOLUTION,
ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE
HYDROCHLORIDE AND
ACETAMINOPHEN ORAL SOLUTION (_SEE _WARNINGS).
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN ORAL
SOLUTION DURING
PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAW