HYDROCODONE BITARTRATE AND ACETAMINOPHEN- hydrocodone bitartrate and acetaminophen tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Disponible des:

Unit Dose Services

Designació comuna internacional (DCI):

HYDROCODONE BITARTRATE

Composición:

HYDROCODONE BITARTRATE 5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Hydrocodone Bitartrate and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Hydrocodone Bitartrate and Acetaminophen Tablets are contraindicated in patients with: Hydrocodone Bitartrate and Acetaminophen Tablets contain hydrocodone, a Schedule II controlled substance. Hydrocodone Bitartrate and Acetaminophen Tablets contain hydrocodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol, can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. All patients treated with o

Resumen del producto:

Product: 50436-3918 NDC: 50436-3918-1 30 TABLET in a BOTTLE

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

HYDROCODONE BITARTRATE AND ACETAMINOPHEN - HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
Unit Dose Services
----------
MEDGUIDE
Medication Guide
Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and
Acetaminophen ( a seet” a min’ oh fen)
Tablets CII
Hydrocodone Bitartrate and Acetaminophen Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require an opioid pain medicine, when other pain
treatments such as non-opioid
pain medicines do not treat your pain well enough or you cannot
tolerate them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse,
and misuse that can lead to death.
Important information about Hydrocodone Bitartrate and Acetaminophen
Tablets:
•
Get emergency help right away if you take too much Hydrocodone
Bitartrate and Acetaminophen
Tablets (overdose). When you first start taking Hydrocodone Bitartrate
and Acetaminophen Tablets,
when your dose is changed, or if you take too much (overdose), serious
or life-threatening breathing
problems that can lead to death may occur.
•
Taking Hydrocodone Bitartrate and Acetaminophen Tablets with other
opioid medicines,
benzodiazepines, alcohol, or other central nervous system depressants
(including street drugs) can
cause severe drowsiness, decreased awareness, breathing problems,
coma, and death.
•
Never give anyone else your Hydrocodone Bitartrate and Acetaminophen
Tablets. They could die
from taking it. Store Hydrocodone Bitartrate and Acetaminophen Tablets
away from children and in
a safe place to prevent stealing or abuse. Selling or giving away
Hydrocodone Bitartrate and
Acetaminophen Tablets is against the law.
Do not take Hydrocodone Bitartrate and Acetaminophen Tablets if you
have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
Known hyper

Fitxa tècnica

HYDROCODONE BITARTRATE AND ACETAMINOPHEN - HYDROCODONE BITARTRATE AND
ACETAMINOPHEN TABLET
UNIT DOSE SERVICES
----------
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); 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].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND
MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A REMS FOR
THESE PRODUCTS
[SEE WARNINGS]. UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES
WITH APPROVED
OPIOID ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO
HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO
•
•
•
•
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
DURI