OXYCODONE AND ASPIRIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)

Available from:

Actavis Pharma, Inc.

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 4.8355 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone and aspirin 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 aspirin 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 aspirin 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 or aspirin, (e.g. angioedema) (see WARNINGS) - Patients with hemophilia. - Aspi

Product summary:

Oxycodone and Aspirin Tablets, USP are yellow, round biconvex tablets, debossed with WATSON and 3551 on one side and scored on the other side, supplied in bottles of 100 (NDC 0591-3551-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store Oxycodone and Aspirin Tablets, USP securely and dispose of properly (see PRECAUTIONS; Information for Patients/Caregivers). DEA Order Form Required. Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. D 4/2019

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Actavis Pharma, Inc.
----------
MEDICATION GUIDE
Oxycodone and Aspirin (ox″ i koe′ done and as′ pir in) Tablets,
for oral use, CII
Oxycodone and aspirin tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is
used to manage pain severe enough to require an opioid pain medicine
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 aspirin tablets:
•
Get emergency help right away if you take too many oxycodone and
aspirin
tablets (overdose). When you first start taking oxycodone and aspirin
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 aspirin 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 aspirin tablets. They could
die from
taking it. Selling or giving away oxycodone and aspirin tablets is
against the
law.
•
Store oxycodone and aspirin 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 aspirin tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking oxycodone and aspirin tablets 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,

Summary of Product characteristics

OXYCODONE AND ASPIRIN- OXYCODONE AND ASPIRIN TABLET
ACTAVIS PHARMA, INC.
----------
OXYCODONE AND ASPIRIN TABLETS USP CII
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; AND RISKS
FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
OXYCODONE AND ASPIRIN 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 ASPIRIN 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 ASPIRIN TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY
DURING INITIATION OF
OXYCODONE AND ASPIRIN TABLETS OR FOLLOWING A DOSE INCREASE (SEE
WARNINGS).
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF EVEN ONE DOSE OF OXYCODONE AND ASPIRIN
T