OXYCODONE AND ACETAMINOPHEN- oxycodone hydrochloride and acetaminophen tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Oxycodone Hydrochloride (UNII: C1ENJ2TE6C) (oxycodone - UNII:CD35PMG570), Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)

Dostopno od:

Precision Dose, Inc.

INN (mednarodno ime):

Oxycodone Hydrochloride

Sestava:

Oxycodone Hydrochloride 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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. 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 the product (e.g., anaphylaxis) [see WA

Povzetek izdelek:

Oxycodone and Acetaminophen Tablets, USP, 5 mg / 325 mg are supplied as white to off-white, round, flat-faced, beveled edged tablets, debossed "IP203" on obverse and bisect on reverse. They are available as follows: NDC 68094-013-61 One hundred (100) 5 mg/325 mg tablets per carton 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.

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

Precision Dose, Inc.
----------
MEDICATION GUIDE
OXYCODONE AND ACETAMINOPHEN
(OX-I-KOE-DONE AND
A-SEET-A-MIN-OH-FEN) TABLETS CII
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
LI1079 Rev. 04/17
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 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 are
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 and
Acetaminophen Tablets.
Before t

Lastnosti izdelka

OXYCODONE AND ACETAMINOPHEN- OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
TABLET
PRECISION DOSE, INC.
----------
OXYCODONE AND ACETAMINOPHEN
TABLETS, USP 5 MG/325 MG
CII
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; 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].
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 ACETAMINOPHEN TABLETS,
ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF OXYCODONE AND ACETAMINOPHEN TABLETS [SEE
WARNINGS].
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 AND ACETAMINOPHEN TABLETS WITH ALL
CYTOCHROME P450
3A4 INHIBITORS MAY RESULT IN AN INCREASE IN OXYCODONE PLASMA
CONCENTRATIONS, WHICH COULD
INCREASE OR PR