PERCOCET- oxycodone hydrochloride and acetaminophen tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Mckesson Rxpak Inc

INN (আন্তর্জাতিক নাম):

OXYCODONE HYDROCHLORIDE

রচনা:

OXYCODONE HYDROCHLORIDE 5 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

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. DEA Order Form Required. Manufactured for: Endo Pharmaceuticals Inc. Malvern, PA 19355 PERCOCET® is a registered trademark of Endo Pharmaceuticals Inc. © 2016 Endo Pharmaceuticals Inc. All rights reserved. Printed in U.S.A. 8183395 R8 Revised November 2016

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Mckesson Rxpak 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 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. 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.
Store PERCOCET
away from children and in a safe place to prevent stealing or abuse.
Selling or giving away
PERCOCET is against the law.
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 prescription drugs, alcohol addiction, or mental
health problems
Tell your healthcare provider if you are:
•
Pregnant or planning to become pregnant. Prolonged use of PERCOCET
during pregn

পণ্য বৈশিষ্ট্য

PERCOCET- OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET
MCKESSON RXPAK INC
----------
PERCOCET
(OXYCODONE AND ACETAMINOPHEN TABLETS, USP)
CII
RX ONLY
REVISED: NOVEMBER 2016
®
WARNING: ADDICTION, ABUSE, AND MISUSE; 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].
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 FATAL OVERDOSE OF
PERCOCET [SEE WARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF PERCOCET DURING PREGNANCY CAN RESULT IN NEONATAL
OPIOID WITHDRAWAL
SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED,
AND REQUIRES
MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF
OPIOID USE IS
REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE RISK OF
NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE
TREATMENT WILL BE
AVAILABLE [SEE WARNINGS].
CYTOCHROME P450 3A4 INTERACTION
THE CONCOMITANT USE OF PERCOCET WITH ALL CYTOCHROME P450 3A4
INHIBITORS MAY RESULT IN
AN INCREASE IN OXYCODONE PLASMA CONCENTRATIONS, WHICH COULD INCREASE
OR PROLONG ADVERSE
REACTIONS AND MAY CAUSE POTENTIALLY FATAL RESPIRATORY DEPRESSION. IN
ADDITION,
DISCONTINUATION OF A CONCOMITANTLY USED CYTOCHROME P450 3A4 INDUCER
MAY RESULT IN AN
INCREASE IN OXYCODONE PLASMA CON