OXYCODONE HYDROCHLORIDE AND IBUPROFEN tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM)

Доступна с:

Actavis Pharma, Inc.

ИНН (Международная Имя):

OXYCODONE HYDROCHLORIDE

состав:

OXYCODONE HYDROCHLORIDE 5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Oxycodone Hydrochloride and Ibuprofen Tablets are indicated for the management of short term (no more than 7 days) acute to moderate pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Carefully consider the potential benefits and risks of Oxycodone Hydrochloride and Ibuprofen Tablets and other treatment options before deciding to use Oxycodone Hydrochloride and Ibuprofen Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS; Cardiovascular Thrombotic Events, and Gastrointestinal Bleeding, Ulceration, and Perforation ]. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS; Addiction, Abuse, and Misuse ], reserve Oxycodone Hydrochloride and Ibuprofen 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,

Обзор продуктов:

Oxycodone Hydrochloride and Ibuprofen Tablets, 5 mg/400 mg are available as follows: Each yellow, capsule-shaped, film-coated tablet imprinted with 29 on one side and bisect on both sides contains 5 mg of Oxycodone hydrochloride, USP and 400 mg of Ibuprofen, USP.  Tablets are supplied in bottles of 30 (NDC 0228-4029-03) and 100 (NDC 0228-4029-11) and 500 (NDC 0228-4029-50). Dispense in a tight, light-resistant container as defined in the USP. Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Store Oxycodone Hydrochloride and Ibuprofen Tablets securely and dispose of properly [see PRECAUTIONS; Information for Patients ] . Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. F 8/2020

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

COATED
Actavis Pharma, Inc.
----------
MEDICATION GUIDE
Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide)
and Ibuprofen (eye" bue proe' fen) Tablets, CII
Oxycodone Hydrochloride and Ibuprofen Tablets are:
•
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 pain
(less than 7 days), 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.
•
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical
conditions such as different types of arthritis, menstrual cramps, and
other types of short-term
pain.
Important information about Oxycodone Hydrochloride and Ibuprofen
Tablets:
•
Get emergency help or call 911 right away if you take too much
Oxycodone Hydrochloride and
Ibuprofen Tablets (overdose). When you first start taking Oxycodone
Hydrochloride 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. Talk
to your healthcare provider
about naloxone, a medicine for the emergency treatment of an opioid
overdose.
•
Taking Oxycodone Hydrochloride 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 Oxycodone Hydrochloride and Ibuprofen
Tablets. They could die
from taking it. Selling or giving away Oxycodone Hydrochloride and
Ibuprofen Tablets is against
the law.
•
Store Oxycodone Hydrochloride and Ibuprofen Tablets securely, out of
sight and reach of
children, and in a locat

Характеристики продукта

OXYCODONE HYDROCHLORIDE AND IBUPROFEN- OXYCODONE HYDROCHLORIDE AND
IBUPROFEN TABLET, FILM COATED
ACTAVIS PHARMA, INC.
----------
OXYCODONE HYDROCHLORIDE AND IBUPROFEN TABLETS
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
OXYCODONE HYDROCHLORIDE 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 OXYCODONE HYDROCHLORIDE AND
IBUPROFEN 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
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 OXYCODONE
HYDROCHLORIDE AND IBUPROFEN TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY
DURING INITIATION O