OXYCODONE AND ACETAMINOPHEN tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

RedPharm Drug, Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Oxycodone 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 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 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 c

leaflet_short:

Oxycodone and Acetaminophen Tablets, USP are supplied as follows: Oxycodone and Acetaminophen Tablets, USP 5 mg/325 mg Blue, round tablet, debossed with "ALV" over "196", separated by a bisect, on one side, and plain on the other side. Bottles of 100: NDC 47781-196-01 Bottles of 250: NDC 47781-196-63 Bottles of 500: NDC 47781-196-05 Oxycodone and Acetaminophen Tablets, USP 7.5 mg/325 mg Orange to yellow, round tablet, debossed with “229” on one side and “ ”on the other side. Bottles of 100: NDC 47781-229-01 Bottles of 250: NDC 47781-229-63 Bottles of 500: NDC 47781-229-05 Oxycodone and Acetaminophen Tablets, USP 10 mg/325 mg Yellow, round tablet, debossed with “230” on one side and “ ” on the other side. Bottles of 100: NDC 47781-230-01 Bottles of 250: NDC 47781-230-63 Bottles of 500: NDC 47781-230-05 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 Oxycodone and Acetaminophen Tablets, USP securely and dispose of properly [see PRECAUTIONS; Information for Patients].

מצב אישור:

Abbreviated New Drug Application

עלון מידע

OXYCODONE AND ACETAMINOPHEN- oxycodone and acetaminophen tablet
RedPharm Drug, Inc.
Reference Label Set Id: 94b95304-8d3b-496a-8d2c-22ae89688427
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Medication Guide
Oxycodone (ox" i koe' done) and Acetaminophen (a seet" a min' oh fen)
Tablets, CII
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 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. 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 is 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 narrowing of the stomach or intestines
•
known hypersensitivity to oxycodone, ace

מאפייני מוצר

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
REDPHARM DRUG, INC.
REFERENCE LABEL SET ID: 94B95304-8D3B-496A-8D2C-22AE89688427
----------
OXYCODONE AND ACETAMINOPHEN 5/325MG TAB
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 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 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 AND ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY DURING INITIATION OF OXYCODONE AND
ACETAMINOPHEN
TABLETS OR FOLLOWING A DOSE IN