Oxycodone and Aspirin Tablets, USP

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

Oxycodone Hydrochloride (UNII: C1ENJ2TE6C) (Oxycodone - UNII:CD35PMG570), Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E)

Доступна с:

Mayne Pharma Inc.

ИНН (Международная Имя):

Oxycodone Hydrochloride

состав:

Oxycodone Hydrochloride 4.8355 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses (see WARNINGS), reserve oxycodone and aspirin 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 and aspirin 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 oxycodone or aspirin, (e.g. angioedema) (see WARNINGS) - Patients with hemophilia. - Aspirin should not be us

Обзор продуктов:

Oxycodone and aspirin tablets, USP, are supplied as a white, round, standard convex, scored tablet debossed with 117 above the score on one side of the tablet and blank on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Store oxycodone and aspirin tablets securely and dispose of properly (see PRECAUTIONS, Information for Patients/Caregivers).

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

OXYCODONE AND ASPIRIN- OXYCODONE HYDROCHLORIDE AND ASPIRIN TABLET
Mayne Pharma Inc.
----------
MEDICATION GUIDE
OXYCODONE AND ASPIRIN TABLETS (OX-EE-CO-DOHN AND AS-PIR-IN), FOR ORAL
USE, CII
This Medication Guide has been approved by
the U.S. Food and Drug Administration.
Issued: March 2021
Oxycodone and aspirin 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 oxycodone and aspirin tablets:
•
Get emergency help or call 911 right away if you take too much
oxycodone and aspirin tablets
(overdose). When you first start taking oxycodone and aspirin 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 and aspirin 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 and aspirin tablets. They could
die from taking it. Selling
or giving away oxycodone and aspirin tablets is against the law.
•
Store oxycodone and aspirin 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 and aspirin tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach o

Характеристики продукта

OXYCODONE AND ASPIRIN- OXYCODONE HYDROCHLORIDE AND ASPIRIN TABLET
MAYNE PHARMA INC.
----------
OXYCODONE AND ASPIRIN 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; AND RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
OXYCODONE AND ASPIRIN 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
AND ASPIRIN 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 AND ASPIRIN TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY DURING INITIATION OF OXYCODONE AND ASPIRIN
TABLETS
OR FOLLOWING A DOSE INCREASE (SEE WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF OXYCODONE AND ASPIRIN