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 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] 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 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 any other component of the pr

Product summary:

Oxycodone and Acetaminophen Tablets, USP are supplied as follows: 2.5 mg/325 mg White to off-white, round tablets, debossed with “U14” on one side and plain on the other side. Bottles of 30 NDC 13107-043-30 Bottles of 100 NDC 13107-043-01 Bottles of 500 NDC 13107-043-05 Bottles of 1000 NDC 13107-043-99 5 mg/325 mg White to off-white, capsule-shaped tablets, debossed with “U15” on one side and break line on the other side. Bottles of 30 NDC 13107-044-30 Bottles of 100 NDC 13107-044-01 Bottles of 500 NDC 13107-044-05 Bottles of 1000 NDC 13107-044-99 7.5 mg/325 mg White to off-white, oval-shaped tablets, debossed with “U16” on one side and plain on the other side. Bottles of 30 NDC 13107-045-30 Bottles of 100 NDC 13107-045-01 Bottles of 500 NDC 13107-045-05 Bottles of 1000 NDC 13107-045-99 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 30 NDC 13107-046-30 Bottles of 100 NDC 13107-046-01 Bottles of 500 NDC 13107-046-05 Bottles of 1000 NDC 13107-046-99 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 Revised: 12/2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE AND ACETAMINOPHEN- oxycodone and acetaminophen tablet
RedPharm Drug, Inc.
----------
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
Acetaminophen Tablets
Before taking oxy

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
REDPHARM DRUG, INC.
----------
OXY/APAP 5/325
BOXED WARNING
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 [seeWARNINGS].
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 potentially
fatal