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:

Proficient Rx LP

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 10 mg

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 ] Oxycodone  and acetaminophen tablets are contraindicated in patients with:  Controlled Substance Oxycodone  and acetaminophen tablet contains oxycodone and acetaminophen, a Schedule CII controlled substance. Abuse Oxycodone and Acetaminophen Tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. Oxycodone  and Acetaminophen Tablets can be abused and is   subject to misuse, addiction, and criminal diversion [see WARNINGS ].  All patients tr

Product summary:

Oxycodone and Acetaminophen Tablets, USP are supplied as follows: 10 mg/325 mg White to off-white, capsule-shaped tablets, debossed with “U17” on one side and plain on the other side.          Bottles of 15             NDC 63187-523-15          Bottles of 20             NDC 63187-523-20          Bottles of 30             NDC 63187-523-30          Bottles of 60             NDC 63187-523-60          Bottles of 90             NDC 63187-523-90 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). DEA Order Form Required. Dispense with Medication Guide available atwww.aurobindousa.com/product-medication-guides Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Repackaged by: Proficient Rx LP. Thousand Oaks, CA 91320 Revised: 12/2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
Proficient Rx LP
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SPL MEDGUIDE
MEDICATION GUIDE
Oxycodone and Acetaminophen Tablets, USP CII
ok″se-ko´dōn and ass-eet-ah-MEE-noe-fen
Oxycodone and acetaminophen tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used for the
management of relief of moderate to moderately severe pain, pain
severe enough to require an
opioid analgesic and for which alternative treatments are inadequate
or when 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 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.
•
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.
Store oxycodone and acetaminophen tablets away from children and in a
safe place to prevent
stealing or abuse. Selling or giving away oxycodone and acetaminophen
tablets is against the law.
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, acetaminophen, or any ingredient
in Oxycodone
Hydrochloride and Acetaminop

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
PROFICIENT RX LP
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OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII
BOXED WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4
INTERACTION, HEPATOTOXICITY AND 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 OR
CONDITIONS[SEEWARNINGS].
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
[S EEWARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF OXYCODONE AND ACETAMINOPHEN TABLETS,
ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF OXYCODONE AND ACETAMINOPHEN TABLETS
[SEEWARNINGS].
NEONATAL OPIOID WITHDRAWAL SYNDROME
PROLONGED USE OF OXYCODONE AND ACETAMINOPHEN TABLETS DURING PREGNANCY
CAN RESULT IN
NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF
NOT RECOGNIZED AND
TREATED, AND REQUIRES MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY
NEONATOLOGY
EXPERTS. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD IN A
PREGNANT WOMAN, ADVISE THE
PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE
THAT APPROPRIATE
TREATMENT WILL BE AVAILABLE [SEE WARNINGS].
CYTOCHROME P450 3A4 INTERACTION
THE CONCOMITANT USE OF OXYCODONE TABLETS WITH ALL CYTOCHROME P450 3A4
INHIBITORS MAY
RESULT IN AN INCREASE IN OXYCODONE PLASMA CONCENTRATIONS, WHICH COULD
INCREASE OR PROLONG
ADVERSE REACTIONS AND MAY CAUSE POT