OXYCODONE AND ACETAMINOPHEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Patient Information leaflet (PIL)

20-02-2018

Summary of Product characteristics (SPC)

20-02-2018

Active ingredient:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

Camber Pharmaceuticals, Inc.

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 2.5 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.,

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

Camber Pharmaceuticals, 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 Tablets, tell your
healthcare provider if you have a history

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Summary of Product characteristics

OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET
CAMBER PHARMACEUTICALS, INC.
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OXYCODONE AND ACETAMINOPHEN TABLETS, USP 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 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 CA

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