OXYCODONE AND ACETAMINOPHEN- oxycodone hydrochloride and acetaminophen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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, acetaminophe

Product summary:

Oxycodone and Acetaminophen Tablets, USP, 2.5 mg/325 mg, supplied as a pink, oval, convex tablet, debossed "4825" on one side and debossed "V" on the reverse side, 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 and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients ].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Par Pharmaceutical, Inc.
----------
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
•

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
PAR PHARMACEUTICAL, INC.
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP
2.5 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