OXYCODONE AND ACETAMINOPHEN tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Aurolife Pharma, LLC

INN（国際名）:

OXYCODONE HYDROCHLORIDE

構図:

OXYCODONE HYDROCHLORIDE 2.5 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Oxycodone and acetaminophen tablets are 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 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  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, acetaminophen, or any other component of the product

製品概要:

Oxycodone and Acetaminophen Tablets, USP are supplied as follows: 2.5 mg/325 mg White to off-white, round tablets, debossed with “U14” on one side and plain on the other side.          Bottles of 30                 NDC 13107-043-30          Bottles of 100               NDC 13107-043-01          Bottles of 500               NDC 13107-043-05          Bottles of 1000             NDC 13107-043-99 5 mg/325 mg White to off-white, capsule-shaped tablets, debossed with “U15” on one side and break line on the other side.          Bottles of 30                 NDC 13107-044-30          Bottles of 100               NDC 13107-044-01          Bottles of 500               NDC 13107-044-05          Bottles of 1000             NDC 13107-044-99 7.5 mg/325 mg White to off-white, oval-shaped tablets, debossed with “U16” on one side and plain on the other side.          Bottles of 30                 NDC 13107-045-30          Bottles of 100               NDC 13107-045-01          Bottles of 500               NDC 13107-045-05          Bottles of 1000             NDC 13107-045-99 10 mg/325 mg White to off-white, capsule-shaped tablets, debossed with “U17” on one side and plain on the other side.          Bottles of 30                 NDC 13107-046-30          Bottles of 100               NDC 13107-046-01          Bottles of 500               NDC 13107-046-05          Bottles of 1000             NDC 13107-046-99 Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Dispense with Medication Guide available at  https://www.aurobindousa.com/medication-guides/ Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 08/2020

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

OXYCODONE AND ACETAMINOPHEN - OXYCODONE AND ACETAMINOPHEN TABLET
Aurolife Pharma, LLC
----------
MEDICATION GUIDE
Oxycodone and Acetaminophen Tablets, USP CII
ok″se-ko´dōn and ass-eet-ah-MEE-noe-fen
Oxycodone 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 and acetaminophen tablets:
•
Get emergency help or call 911 right away if you take too much
oxycodone and acetaminophen
tablets (overdose). When you first start taking oxycodone 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. Talk to your healthcare provider
about naloxone, a medicine for
the emergency treatment of an opioid overdose.
•
Taking oxycodone 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 and Acetaminophen Tablets. They
could die from taking
it. Selling or giving away Oxycodone and Acetaminophen Tablets are
against the law.
•
Store Oxycodone 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 and acetaminophen tablets if you have:
•
Severe asthma, trouble breathing, or other lung problems.
•
A bowel blockage or have narrowin

製品の特徴

OXYCODONE AND ACETAMINOPHEN - OXYCODONE AND ACETAMINOPHEN TABLET
AUROLIFE PHARMA, LLC
----------
OXYCODONE AND ACETAMINOPHEN 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, HEPATOTOXICITY AND AND
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
OXYCODONE 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 AND ACETAMINOPHEN
TABLETS, AND MONITOR ALL
PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS OR
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 ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY
DURING INITIATION OF OXYCODONE AND ACETAMINOPHEN TABLETS OR FOLLOWING
A DOSE INCREASE
[SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENT