OXYCODONE AND ACETAMINOPHEN- oxycodone and acetaminophen tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Actavis Pharma, Inc.

INN (International Nazwa):

OXYCODONE HYDROCHLORIDE

Skład:

OXYCODONE HYDROCHLORIDE 2.5 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Oxycodone and Acetaminophen Tablets, USP 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 produc

Podsumowanie produktu:

Oxycodone and acetaminophen tablets, USP are available as follows: 2.5 mg/325 mg –White to off-white, oval tablets, debossed “A331” on one side and plain on the other side. Tablets are supplied in bottles of 100 (NDC 0228-2980-11) with child-resistant closure. 5 mg/325 mg – White to off-white, round tablets, debossed “A349” on bisected side and plain on the other side. Tablets are supplied in bottles of 100 (NDC 0228-2981-11) with child-resistant closure, and 500 (NDC 0228-2981-50) without a child-resistant closure. 7.5 mg/325 mg – White to off-white, capsule-shaped tablets, debossed “A332” on one side and plain on the other side. Tablets are supplied in bottles of 100 (NDC 0228-2982-11) with child-resistant closure. 10 mg/325 mg – White to off-white, modified capsule-shaped tablets, debossed “A333” on one side and plain on the other side. Tablets are supplied in bottles of 100 (NDC 0228-2983-11) with child-resistant closure, and 500 (NDC 0228-2983-50) without a child-resistant closure. Storage 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, with a child-resistant closure (as required). Store Oxycodone and Acetaminophen Tablets, USP securely and dispose of properly [see PRECAUTIONS; Information for Patients/Caregiver ]. Manufactured by: Warner Chilcott Company, LLC Manati, Puerto Rico 00674 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. D 8/2019

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

Actavis Pharma, Inc.
----------
MEDICATION GUIDE
Oxycodone (ox" i koe' done) and Acetaminophen (a seet" a min' oh fen)
Tablets USP, 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 many 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. Store Oxycodone and Acetaminophen Tablets
away from children and in a safe place to prevent stealing or abuse.
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 narrowing of the stomach or intestines
•
Known hypersensitivity to oxycodone, acetaminophe

Charakterystyka produktu

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
ACTAVIS PHARMA, INC.
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP
CII
Rev. D 8/2019
RX ONLY
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 EXPOSE 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
RIS KS , 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
WARN