ENDOCET- oxycodone and acetaminophen tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Par Pharmaceutical, Inc.

INN:

OXYCODONE HYDROCHLORIDE

composition:

OXYCODONE HYDROCHLORIDE 2.5 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

ENDOCET 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 ENDOCET 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 ENDOCET 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, or any other component of the product (e.g., anaphylaxis) [see WARNINGS , ADVERSE REACTIONS ] ENDOCET contains oxycodone, a

leaflet_short:

ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows: 2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100                                  NDC 60951-701-70 5 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100                                  NDC 60951-602-70 Bottles of 500                                  NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100                                  NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100                                  NDC 60951-712-70 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Store ENDOCET securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. Dispense in a tight, light-resistant container as defined in the USP. DEA Order Form Required. Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 ENDOCET® is a registered trademark of Endo Pharmaceuticals Inc. © 2017 Endo Pharmaceuticals Inc. All rights reserved. Printed in U.S.A. Revised: 08/20

authorization_status:

Abbreviated New Drug Application

PIL

Par Pharmaceutical, Inc.
----------
Medication Guide
ENDOCET®(ˈEn-dō-ˌset) Tablets,
CII
ENDOCET is:
•
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 ENDOCET tablets:
•
Get emergency help right away or call 911 if you take too much ENDOCET
(overdose).
When you first start taking ENDOCET, 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 ENDOCET 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 ENDOCET. They could die from taking it.
Selling or
giving away ENDOCET is against the law.
•
Store ENDOCET securely, our of sight and reach of children, and in a
location not
accessible by others, including visitors to the home.
Do not take ENDOCET if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowing of the stomach or intestines.
•
Known hypersensitivity to oxycodone, acetaminophen, or any ingredient
in ENDOCET.
Before taking ENDOCET, tell your healthcare provider if you have a
history of:
•
Head injury, seizures
•
Liver, kidney, thyroid problems
•
Problems urinating
•
Pancreas or gallbladder problems
•
Abuse of street or prescription drugs,

SPC

ENDOCET- OXYCODONE AND ACETAMINOPHEN TABLET
PAR PHARMACEUTICAL, INC.
----------
ENDOCET
OXYCODONE AND ACETAMINOPHEN TABLETS, USP
CII
RX ONLY
REVISED: AUGUS 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
ENDOCET 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 ENDOCET, 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 ENDOCET. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING
INITIATION OF ENDOCET OR FOLLOWING A DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF ENDOCET, ESPECIALLY BY CHILDREN, CAN RESULT IN
A
FATAL OVERDOSE OF ENDOCET [S