OXYCODONE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eywa Pharma Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 component of t

Product summary:

Oxycodone and Acetaminophen Tablets, USP: 5 mg/325 mg Blue colored, round tablets, one side scored and the other side debossed with WES 201 Bottles of 100         NDC 71930-045-12 Bottles of 500         NDC 71930-045-52 7.5 mg/325 mg Pink colored, capsule shaped tablets, one side debossed with WES 202 and other side debossed with 7.5/325 Bottles of 100        NDC 71930-046-12 Bottles of 500        NDC 71930-046-52 10 mg/325 mg White colored, capsule shaped tablets, one side debossed with WES 203 and other side debossed with 10/325 Bottles of 100        NDC 71930-047-12 Bottles of 500        NDC 71930-047-52 Storage 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 Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients]. Manufactured by:  WES Pharma Inc. Westminster, MD 21157 Manufactured For: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540 Revised: 08/2020

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Eywa Pharma Inc
----------
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 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 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, ac

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN - OXYCODONE AND ACETAMINOPHEN TABLET
EYWA PHARMA INC
----------
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 INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF OXYCODONE AND ACETAM