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:

RedPharm Drug, Inc,

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Oxycodone Hydrochloride and Acetaminophen Tablets is 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] 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 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, acetamin

Product summary:

Oxycodone Hydrochloride and Acetaminophen Tablets, USP, 5 mg/325 mg, supplied as a white round tablet, with one face, scored debossed 4839 and V, and the other plain, are available as follows: Bottles of 100: NDC 0603-4998-21 Bottles of 500: NDC 0603-4998-28 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. DEA Order Form Required.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
RedPharm Drug, Inc,
----------
MEDICATION GUIDE
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 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. 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. Store Oxycodone Hydrochloride and Acetaminophen
Tablets away from children and in a
safe place to prevent stealing or abuse. Selling or giving away
Oxycodone Hydrochloride and
Acetaminophen Tablets are against the law.
Do not take Oxycodone Hydrochloride 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 hy

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
REDPHARM DRUG, INC,
----------
BOXED WARNING
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 Hydrochloride 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 Hydrochloride 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
Hydrochloride and Acetaminophen Tablets. Monitor for respiratory
depression, especially
during initiation of Oxycodone Hydrochloride and Acetaminophen Tablets
or following a dose
increase [see WARNINGS].
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
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 Hydrochloride Tablets with all
cytochrome P450 3A4
inhibitors may result in an increase in oxycodone plasma
concentratio