HYDROCODONE BITARTRATE AND ACETAMINOPHEN tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)

Disponible desde:

A-S Medication Solutions

Designación común internacional (DCI):

HYDROCODONE BITARTRATE

Composición:

HYDROCODONE BITARTRATE 5 mg

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
A-S MEDICATION SOLUTIONS
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII
RX ONLY
BOXED WARNING
WARNING: 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
Addiction, Abuse, and Misuse Hydrocodone Bitartrate and Acetaminophen
Tablets expose
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
Hydrocodone Bitartrate and
Acetaminophen 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 Hydrocodone
Bitartrate and Acetaminophen Tablets. Monitor for respiratory
depression, especially during
initiation of Hydrocodone Bitartrate and Acetaminophen Tablets or
following a dose increase
[see WARNINGS].
Accidental Ingestion Accidental ingestion of Hydrocodone Bitartrate
and Acetaminophen Tablets,
especially by children, can result in a fatal overdose of Hydrocodone
Bitartrate and
Acetaminophen Tablets [SEE WARNINGS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of Hydrocodone Bitartrate and Acetaminophen 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].
Cytochrome P450 3A4 Interaction
The concomitant use of Hydrocodone Bitartrate and Acetaminophen
Ta