PERCOCET- oxycodone hydrochloride and acetaminophen tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Endo Pharmaceuticals Inc.

INN（国际名称）:

OXYCODONE HYDROCHLORIDE

组成:

OXYCODONE HYDROCHLORIDE 2.5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

PERCOCET 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 PERCOCET 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 PERCOCET 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 ] PERCOCET contains oxycodone, a

產品總結:

PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows: 2.5 mg/325 mg Pink, oval, tablet, debossed with “PERCOCET” on one side and “2.5” on the other. Bottles of 100                                  NDC 63481-627-70 5 mg/325 mg Blue, round, tablet, debossed with “PERCOCET” and “5” on one side and bisect on the other. Bottles of 100                                  NDC 63481-623-70 Bottles of 500                                  NDC 63481-623-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “PERCOCET” on one side and “7.5/325” on the other. Bottles of 100                                  NDC 63481-628-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “PERCOCET” on one side and “10/325” on the other. Bottles of 100                                  NDC 63481-629-70 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. Store PERCOCET securely and dispose of properly [see PRECAUTIONS/Information for Patients ]. DEA Order Form Required. Distributed by: Endo Pharmaceuticals Inc. Malvern, PA 19355 Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 PERCOCET® is a registered trademark of Endo Pharmaceuticals Inc. © 2017 Endo Pharmaceuticals Inc. All rights reserved. Printed in U.S.A. Revised: August 2020 

授权状态:

Abbreviated New Drug Application

资料单张

Endo Pharmaceuticals Inc.
----------
Medication Guide
PERCOCET® (ˈpər-kō-ˌset)
Tablets, CII
PERCOCET 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 PERCOCET tablets:
•
Get emergency help or call 911 right away if you take too much
PERCOCET (overdose).
When you first start taking PERCOCET, 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 PERCOCET 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 PERCOCET. They could die from taking it.
Selling or giving
away PERCOCET is against the law.
•
Store PERCOCET securely, out of sight and reach of children, and in a
location not accessible
by others, including visitors to the home.
Do not take PERCOCET 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 PERCOCET.
Before taking PERCOCET, 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 pres

产品特点

PERCOCET- OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET
ENDO PHARMACEUTICALS INC.
----------
PERCOCET
(OXYCODONE AND ACETAMINOPHEN TABLETS, USP)
CII
RX ONLY
REVISED: AUGUST 2020
®
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
PERCOCET 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 PERCOCET, 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 PERCOCET. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING
INITIATION OF PERCOCET OR FOLLOWING A DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF PERCOCET, ESPECIALLY BY CHILDREN, CAN RESULT
IN A
FA