TARGINIQ ER- oxycodone hydrochloride/naloxone hydrochloride tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), NALOXONE HYDROCHLORIDE (UNII: F850569PQR) (NALOXONE - UNII:36B82AMQ7N)

Available from:

Purdue Pharma LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TARGINIQ ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)] , reserve TARGINIQ ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - TARGINIQ ER is not indicated as an as-needed (prn) analgesic. - The maximum total daily dose of TARGINIQ ER should not exceed 80 mg/40 mg (40 mg/20 mg q12h) because higher doses may be associated with symptoms of opioid withdrawal or decreased analgesia [see Warnings and Precautions 5.12] . TARGINIQ ER is contraindicated in patients

Product summary:

TARGINIQ ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) 10 mg/5 mg are capsule shaped, white film-coated tablets debossed with “ONX” on one side and “10” on the other and are supplied as child-resistant closure, opaque HDPE bottles of 100 (NDC 59011-520-01). TARGINIQ ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) 20 mg/10 mg are capsule shaped, pink film-coated tablets debossed with “ONX” on one side and “20” on the other and are supplied as child-resistant closure, opaque HDPE bottles of 100 (NDC 59011-521-01) . TARGINIQ ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) 40 mg/20 mg are capsule shaped, yellow film-coated tablets debossed with “ONX” on one side and “40” on the other and are supplied as child-resistant closure, opaque HDPE bottles of 100 (NDC 59011-522-01) . Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container, with a child-resistant closing. CAUTION DEA FORM REQUIRED

Authorization status:

New Drug Application

Patient Information leaflet

Purdue Pharma LP
----------
Medication Guide
TARGINIQ™ ER (tar-gih-NEEK E-R)
(oxycodone hydrochloride and naloxone hydrochloride extended-release
tablets), CII
TARGINIQ ER is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain
severe enough to require daily, around-the-clock, long-term treatment
with an opioid, when other
pain treatments such as non-opioid pain medicines or immediate-release
opioid medicines do not
treat your pain well enough or you cannot tolerate them.
•
A long-acting (extended-release) 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.
•
Not for use to treat pain that is not around-the-clock.
Important information about TARGINIQ ER:
•
Get emergency help right away if you take too much TARGINIQ ER
(overdose). When you first
start taking TARGINIQ ER, 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 TARGINIQ ER 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 TARGINIQ ER. They could die from taking
it. Store TARGINIQ
ER away from children and in a safe place to prevent stealing or
abuse. Selling or giving away
TARGINIQ ER is against the law.
Do not take TARGINIQ ER if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking TARGINIQ ER, tell your healthcare provider if you have a
history of:
•
head injury, seizures
•
liver, kidney, thyroid or heart problems
•
abuse of street or prescription drugs, alcohol
addiction, or mental health problems
•
problems urinating
•
pancreas or gallbladder pr

Summary of Product characteristics

TARGINIQ ER- OXYCODONE HYDROCHLORIDE/NALOXONE HYDROCHLORIDE TABLET,
FILM COATED, EXTENDED
RELEASE
PURDUE PHARMA LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TARGINIQ™ ER SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR TARGINIQ ER.
TARGINIQ ER (OXYCODONE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS), FOR ORAL USE,
CII
INITIAL U.S. APPROVAL: 2014
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME
P450 3A4
INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND
OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
RECENT MAJOR CHANGES
Box Warning
12/2016
Indications and Usage (1)
12/2016
Dosage and Administration (2)
12/2016
Warning and Precautions (5)
12/2016
INDICATIONS AND USAGE
TARGINIQ ER is a combination product consisting of oxycodone, an
opioid agonist, and naloxone, an opioid antagonist,
indicated for the management of pain severe enough to require daily,
around-the-clock, long-term opioid treatment and for
which alternative treatment options are inadequate. (1)
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, and because of the
greater risks of overdose and death with extended-release opioid
formulations, reserve TARGINIQ ER for use in
patients for whom alternative treatment options (e.g., non-opioid
analgesics or immediate-release opioids) are
ineffective, not tolerated, or would be otherwise inadequate to
provide sufficient management of pain. (1)
TARGINIQ ER is not indicated as an as-needed (prn) analgesic. (1)
Total daily dose should not exceed 80 mg/40 mg (40 mg/20 mg q12h)
because higher doses may be associated with
symptoms of opioid withdrawal. (1)
TARGINIQ ER EXPOSES USERS TO RISKS OF ADDICTION, ABUSE AND MISUSE,
WHICH CAN LEAD TO OVERDOSE AND
DEATH. ASSESS PATIENT’S RISK BEFORE PRESCR