OXYCODONE AND ACETAMINOPHEN tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

West-Ward Pharmaceuticals Corp.

DCI (Dénomination commune internationale):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. Limitations of Use: 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] Oxycodone Hydrochloride and Acetaminophen Tablets are contraindicated in patients with: Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, a Schedule II controlled substance. Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. Oxycodone Hydrochloride and Acetaminophen Tablets can be abused and are subject to misuse, addiction, and criminal diversion [se

Descriptif du produit:

Oxycodone and Acetaminophen Tablets USP 5 mg/325 mg Tablets are supplied as white biconvex tablets, scored on one side and product identification “54” over “543” debossed on the other side. NDC 0054-0551-24: 4 Cards x 25 Unit-Dose Tablets (reverse-numbered) NDC 0054-0551-25: Bottle of 100 Tablets NDC 0054-0551-29: Bottle of 500 Tablets 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, child-resistant container as defined in the USP/NF. Store Oxycodone and Acetaminophen Tablets USP securely and dispose of properly [see PRECAUTIONS; Information for Patients] . DEA Order Form Required. Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724 10009541/06 Revised July 2020

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

West-Ward Pharmaceuticals Corp.
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MEDICATION GUIDE
Oxycodone (ox" i koe' done) and Acetaminophen (a seet" a min' oh fen)
Tablets USP CII
Rx only
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 when 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 much
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:
•
Severe asthma, trouble b

Résumé des caractéristiques du produit

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
WEST-WARD PHARMACEUTICALS CORP.
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OXYCODONE AND ACETAMINOPHEN TABLETS USP CII
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 OR CONDITIONS _[SEEWARNINGS]._
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
_[SEEWARNINGS]._ 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
•
•
•
•
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 ACETAMINOPHEN TABLETS
OR FOLLOWING A
DOSE INCREASE _[SEEWARNINGS]_.
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
TABLETS, ESPECIALLY
BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE HYDROCHLORIDE
AND ACETAMINOPHEN
TABLETS _[SEE WARNINGS]._
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS
DURING PREGNANCY
CAN