HYDROCODONE BITARTRATE AND IBUPROFEN tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Disponible desde:

Par Pharmaceutical, Inc.

Designación común internacional (DCI):

HYDROCODONE BITARTRATE

Composición:

HYDROCODONE BITARTRATE 7.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation) . Do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (see WARNINGS: Addiction, Abuse, and Misuse) , reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., non-opioid anal

Resumen del producto:

Hydrocodone Bitartrate and Ibuprofen Tablets 5 mg/200 mg are white, film-coated, oval shaped, scored tablets, debossed "3584" on one side and debossed "V" on the reverse side. They are supplied as follows: Hydrocodone Bitartrate and Ibuprofen Tablets 7.5 mg/200 mg are white, film-coated, round, debossed “3585” on one side and debossed “V” on the reverse side. They are supplied as follows: Hydrocodone Bitartrate and Ibuprofen Tablets 10 mg/200 mg are purple, film-coated, oval shaped, scored tablets, debossed "3586" on one side and debossed "V" on the reverse side. They are supplied as follows: Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. A Schedule CS-II Controlled Substance. Store hydrocodone bitartrate and ibuprofen tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients] .

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

HYDROCODONE BITARTRATE AND IBUPROFEN- HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET, FILM COATED
Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Hydrocodone Bitartrate and Ibuprofen Tablets CII
(hye” droe koe’ done bye tar’ trate and eye'' bue proe' fen)
Hydrocodone bitartrate and ibuprofen tablets is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
and a non-steroidal anti-
inflammatory drug (NSAID), that is used to manage short-term (acute)
pain, 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 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.
•
NSAIDs are used to treat pain, redness, swelling, and inflammation.
Important information about hydrocodone bitartrate and ibuprofen
tablets:
•
Get emergency help right away if you take too much hydrocodone
bitartrate and ibuprofen tablets
(overdose). When you first start taking hydrocodone bitartrate and
ibuprofen 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 ibuprofen 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 ibuprofen
tablets. They could die from
taking it. Selling or giving away hydrocodone bitartrate and ibuprofen
tablets is against the law.
•
Store hydrocodone bitartrate and ibuprofen tablets securely, out of
sight and reach of children, and
in a location not accessible by others, including visitors to the
home.
Hydrocodone bitartrate and ibuprofen tablets contain an NSAID. NSAIDs
can cause serious side effects,
including:
�

Ficha técnica

HYDROCODONE BITARTRATE AND IBUPROFEN- HYDROCODONE BITARTRATE AND
IBUPROFEN TABLET, FILM COATED
PAR PHARMACEUTICAL, INC.
----------
HYDROCODONE BITARTRATE AND IBUPROFEN TABLETS
5 MG/200 MG, 7.5 MG/200 MG AND 10 MG/200 MG
CII
RX ONLY
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; RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS; AND SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
ADDICTION, ABUSE, AND MISUSE
HYDROCODONE BITARTRATE AND IBUPROFEN 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 IBUPROFEN TABLETS, AND MONITOR ALL PATIENTS
REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS _(SEE_
_WARNINGS: ADDICTION, ABUSE, AND MISUSE)_.
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 IBUPROFEN TA