OXYCODONE AND ACETAMINOPHEN- oxycodone hydrochloride and acetaminophen tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Доступна с:

Par Pharmaceutical

ИНН (Международная Имя):

OXYCODONE HYDROCHLORIDE

состав:

OXYCODONE HYDROCHLORIDE 5 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Oxycodone Hydrochloride and Acetaminophen Tablets is 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 Oxycodone Hydrochloride 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 Oxycodone Hydrochloride and Acetaminophen Tablets is 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 oxycodone, acetaminophen

Обзор продуктов:

Oxycodone Hydrochloride and Acetaminophen Tablets, USP, 5 mg/325 mg, supplied as a white round tablet, with one face, scored debossed 4839 and V, and the other plain, are available as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP. DEA Order Form Required. Store Oxycodone Hydrochloride and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients ].

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

Par Pharmaceutical
----------
Medication Guide
Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide) and
Acetaminophen (a seet" a
min' oh fen) Tablets, CII
Oxycodone Hydrochloride 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 analgesic and for
which alternative
treatments are inadequate and 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 Oxycodone Hydrochloride and Acetaminophen
Tablets:
•
Get emergency help right away if you take too much Oxycodone
Hydrochloride and
Acetaminophen Tablets (overdose). When you first start taking
Oxycodone
Hydrochloride 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 Oxycodone Hydrochloride 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 Oxycodone Hydrochloride and Acetaminophen
Tablets.
They could die from taking it. Selling or giving away Oxycodone
Hydrochloride and
Acetaminophen Tablets is against the law.
•
Store Oxycodone Hydrochloride 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 Oxycodone Hydrochloride 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

Характеристики продукта

OXYCODONE AND ACETAMINOPHEN- OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
TABLET
PAR PHARMACEUTICAL
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP
5 MG/325 MG
CII
RX ONLY
Revised: AUGUST 2019
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
OXYCODONE HYDROCHLORIDE 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 OXYCODONE
HYDROCHLORIDE 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
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 ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY
DURING INITIATION OF OXYCODONE HYDROCHL