HYRDROCODONE APAP tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Direct_Rx

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] Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: • Significant respiratory depression [see WARNINGS] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS] • Hypersensitivity to hydrocodone or

Resumen del producto:

Hydrocodone Bitartrate and Acetaminophen Tablets USP are available in the following strengths: Hydrocodone Bitartrate and Acetaminophen Tablet USP, 5 mg/325 mg is available as white to off-white, round tablets, debossed with “U01” on one side and break-line on the other side. Each tablet contains 5 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 Bottles of 100 Bottles of 500 Bottles of 1000 Hydrocodone Bitartrate and Acetaminophen Tablet USP, 7.5 mg/325 mg is available as white to off-white, capsule shaped tablets, debossed with “U02” on one side and break-line on the other side. Each tablet contains 7.5 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 Bottles of 100 Bottles of 500 Bottles of 1000 Hydrocodone Bitartrate and Acetaminophen Tablet USP, 10 mg/325 mg is available as white to off-white, oval shaped tablets, debossed with “U03” on one side and break-line on the other side. Each tablet contains 10 mg hydrocodone bitartrate and 325 mg acetaminophen. Bottles of 30 Bottles of 100 Bottles of 500 Bottles of 1000 Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store Hydrocodone Bitartrate and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Keep this and all medication out of the reach of children. A Schedule C-II controlled drug substance. Dispense with Medication Guide available at www.aurobindousa.com/product-medication-guides Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 04/2019

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

HYRDROCODONE APAP- hyrdrocodone apap tablet
Direct_Rx
----------
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII
HIGH-droe-KOE-dohn by-TAR-trate/ass-eet-ah-MEE-noe-fen
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. Selling or giving away Hydrocodone Bitartrate and
Acetaminophen Tablets are against the law.
Store Hydrocodone Bitartrate and Acetaminophen Tablets securely, out
of sight and reach of children, and in
a location not accessible by others, including visitors to the home.
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 hypersensitivity to hydrocodone or acetaminophen ,or any
ingredient in hydrocod

Ficha técnica

HYRDROCODONE APAP- HYRDROCODONE APAP TABLET
DIRECT_RX
----------
HYRDROCODONE APAP
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 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
hydrocodone
bitartrate and acetaminophen tablets, and monitor all patients
regularly for the
development of these behaviors or 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
complete a REMS-compliant education program,
counsel patients and/or their caregivers, with every prescription, on
safe use,
serious risks, storage, and disposal of these products,
emphasize to patients and their caregivers the importance of reading
the
Medication Guide every time it is provided by their
pharmacist, and
Consider other tools to improve patient, household, and community
safety.
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 [seeWARNINGS].
Accidental Ingestion
Accidental ingestio