OXYCODONE AND ACETAMINOPHEN- oxycodone hydrochloride 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:

Quality Care Products, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 prod

Product summary:

Each oxycodone and acetaminophen tablet USP 5 mg/325 mg contains oxycodone hydrochloride 5 mg (equivalent to 4.4815 mg oxycodone) and acetaminophen 325 mg. It is available as a round, white scored tablet debossed with a 512 identification number. Each oxycodone and acetaminophen tablet USP 7.5 mg/325 mg contains oxycodone hydrochloride 7.5 mg (equivalent to 6.7228 mg oxycodone) and acetaminophen 325 mg. It is available as a white to off-white caplet shaped tablet debossed with “M522” on one side and “7.5/325” on the other side. 55700-984-30 55700-984-60 55700-984-90 Each oxycodone and acetaminophen tablet USP 10 mg/325 mg contains oxycodone hydrochloride 10 mg (equivalent to 8.9637 mg oxycodone) and acetaminophen 325 mg. It is available as a white to off-white caplet shaped tablet debossed with “M523” on one side and “10/325” on the other side. 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 securely and dispose of properly (see PRECAUTIONS, Information for Patients ). DEA Order Form Required.  Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2020 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 08/2020 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20O10.pdf or by calling 1-800-778-7898 for alternate delivery options.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Quality Care Products, LLC
----------
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 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 many (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 oxycodon

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE HYDROCHLORIDE AND
ACETAMINOPHEN TABLET
QUALITY CARE PRODUCTS, LLC
----------
OXYCODONE AND ACETAMINOPHEN TABLETS USP CII
5 MG*/325 MG, 7.5 MG*/325 MG AND 10 MG*/325 MG
REVISED: AUGUST 2020
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 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
ACETAMINO