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 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 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., ana

Product summary:

HOW SUPPLIED Oxycodone and Acetaminophen Tablets, USP: 2.5 mg/325 mg Off white to light red color capsule shaped tablets with specks and debossed with ‘T 191’ on one side and plain on other side. Bottles of 100 NDC 31722-191-01 Bottles of 500 NDC 31722-191-05 5 mg/325 mg Light blue color round, biconvex tablets with specks having functional score on one side and debossed with ‘T 192’ on other side. Bottles of 100 NDC 31722-192-01 Bottles of 500 NDC 31722-192-05 7.5 mg/325 mg Off -white to light yellow color capsule shaped tablets with specks and debossed with ‘T 193’ on one side and plain on other side. Bottles of 100 NDC 31722-193-01 Bottles of 500 NDC 31722-193-05 10 mg/325 mg Light yellow color capsule shaped tablets debossed with ‘T 194’ on one side plain on other side. Bottles of 100 NDC 31722-194-01 Bottles of 500 NDC 31722-194-05 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. Manufactured by: Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Rev 01/17

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

OXYCODONE AND ACETAMINOPHEN- oxycodone and acetaminophen tablet
RedPharm Drug, Inc.
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MEDICATION GUIDE
Oxycodone (ox" i koe' done ) and Acetaminophen (a seet" a min' oh fen)
Tablets, CII
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 taking Oxycodone and Acetaminophen Table

Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
REDPHARM DRUG, INC.
----------
OXY/APAP
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 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 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
respiratory depre