OXYCODONE AND ACETAMINOPHEN tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Zydus Pharmaceuticals (USA) Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Oxycodone Hydrochloride and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone Hydrochloride 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 Hydrochloride 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

Resumen del producto:

Oxycodone Hydrochloride and Acetaminophen Tablets, USP are supplied as follows: 2.5 mg/325 mg White to off-white, oval tablet, debossed with "1327" on one side and plain on the other. Bottles of 100……………………..NDC 70710-1327-1 5 mg/325 mg White to off-white, round tablet, debossed with "1328" on one side and bisect on the other. Bottles of 100……………………..NDC 70710-1328-1 Bottles of 500……………………..NDC 70710-1328-5 7.5 mg/325 mg White to off-white, oval shaped tablet, debossed with "1329" on one side and plain on the other. Bottles of 100……………………..NDC 70710-1329-1 Bottles of 500……………………..NDC 70710-1329-5 10 mg/325 mg White to off-white, capsule shaped tablet, debossed with "1330" on one side and plain on the other. Bottles of 100……………………..NDC 70710-1330-1 Bottles of 500……………………..NDC 70710-1330-5 Store Oxycodone Hydrochloride and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients] .  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). DEA Order Form Required. Keep this and all drugs out of the reach of children. Manufactured By: Nesher Pharmaceuticals USA LLC St. Louis, MO 63044 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 PI-Rasub-7 August 2020 For additional copies of the printed patient information/medication guide, please visit www.zydus.com or call 1-877-993-8779.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Zydus Pharmaceuticals (USA) Inc.
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Medication Guide
Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide) and
Acetaminophen (a
seet" a min' oh fen) Tablets, CII
Oxycodone Hydrochloride 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 Hydrochloride and Acetaminophen
Tablets:
•
Get emergency help or call 911 right away if you take too many
Oxycodone
Hydrochloride and Acetaminophen Tablets (overdose) . When you first
start taking
Oxycodone Hydrochloride 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 Hydrochloride 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 Hydrochloride and Acetaminophen
Tablets.
They could die from taking it. Selling or giving away Oxycodone
Hydrochloride and
Acetaminophen Tablets is against the law.
•
Store Oxycodone Hydrochloride 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 Hydrochloride and Acetaminophen Tablets if you
have

Fitxa tècnica

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
----------
OXYCODONE AND ACETAMINOPHEN TABLETS, USP
CII
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 HYDROCHLORIDE 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
HYDROCHLORIDE 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
HYDROCHLORIDE AND ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION, ESPECIALLY
DURING INITIATION OF OXYCODONE HYDROCHLORIDE AND ACET