OXYCODONE HYDROCHLORIDE- oxycodone 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)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OXYCODONE HCL EXTENDED-RELEASE TABLETS are 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, reserve OXYCODONE HCL EXTENDED-RELEASE TABLETS 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. - •OXYCODONE HCL EXTENDED-RELEASE TABLETS are not indicated as an as-needed (prn) analgesic OXYCODONE HCL EXTENDED-RELEASE TABLETS are contraindicated in patients with: - •Significant respiratory depression - •Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment - •Know

Product summary:

OXYCODONE HCL EXTENDED-RELEASE TABLETS (oxycodone hydrochloride extended-release tablets) 10 mg are film-coated, round, white-colored, bi-convex tablets debossed with OP on one side and 10 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 49884-136-01 ). OXYCODONE HCL EXTENDED-RELEASE TABLETS (oxycodone hydrochloride extended-release tablets) 20 mg are film-coated, round, pink-colored, bi-convex tablets debossed with OP on one side and 20 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 49884-137-01 ) OXYCODONE HCL EXTENDED-RELEASE TABLETS (oxycodone hydrochloride extended-release tablets) 40 mg are film-coated, round, yellow-colored, bi-convex tablets debossed with OP on one side and 40 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 49884-138-01 ). OXYCODONE HCL EXTENDED-RELEASE TABLETS (oxycodone hydrochloride extended-release tablets) 80 mg are film-coated, round, green-colored, bi-convex tablets debossed with OP on one side and 80 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 49884-197-01 ). Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in tight, light-resistant container. CAUTION DEA FORM REQUIRED

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Par Pharmaceutical, Inc.
----------
This Medication Guide has been
approved by the U.S. Food and
Drug Administration.
Revised: September 2014
Medication Guide
OXYCODONE HCL
EXTENDED-RELEASE
TABLETS ® (ox-e-KON-tin)
(oxycodone hydrochloride
extended-release tablets), CII
OXYCODONE HCL
EXTENDED-RELEASE
TABLETS are:
•
•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
OXYCODONE HCL
EXTENDED-RELEASE
TABLETS :
•
•Get emergency help right
away if you take too much
OXYCODONE HCL
EXTENDED-RELEASE
TABLETS (overdose).
When you first start taking
OXYCODONE HCL
EXTENDED-RELEASE
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.
•
•Never give anyone else
your OXYCODONE HCL
EXTENDED-RELEASE
TABLETS. They could
die from taking it. Store
OXYCODONE HCL
EXTENDED-RELEASE
TABLETS away from
children and in a safe
place to prevent stealing
or abuse. Selling or giving
away OXYCODONE
HCL EXTENDED-
RELEASE TABLETS is
against the law.
Do not take OXYCODONE HCL
EXTENDED-RELEASE
TABLETS if you have:
•
•severe asthma, trouble
breathing, or other lung
problems.
•
•a bowel blockage or have
narrowing of the stomach
or intestines.
Before taking OXYCODONE
HCL EXTENDED-RELEASE
TABLETS , tell your healthcare
provider if you have a history of:
•
•head injury, seizures
•
•liver, kidney, thyroid
proble

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCODONE HCL EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OXYCODONE HCL EXTENDED-RELEASE
TABLETS.
OXYCODONE HCL EXTENDED-RELEASE TABLETS, FOR ORAL USE, CII
INITIAL U.S. APPROVAL: 1950
WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND
CYTOCHROME
P450 3A4 INTERACTION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
•OXYCODONE HCL EXTENDED-RELEASE TABLETS EXPOSES USERS TO RISKS OF
ADDICTIONS, ABUSE AND
MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT’S
RISK BEFORE PRESCRIBING AND
MONITOR REGULARLY FOR DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS.
(5.1)
•SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY
OCCUR. MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW
OXYCODONE HCL EXTENDED-
RELEASE TABLETS TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY FATAL
DOSE OF OXYCODONE. (5.2)
•ACCIDENTAL INGESTION OF OXYCODONE HCL EXTENDED-RELEASE TABLETS ,
ESPECIALLY IN CHILDREN,
CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE. (5.2)
•PROLONGED USE OF OXYCODONE HCL EXTENDED-RELEASE TABLETS DURING
PREGNANCY CAN RESULT IN
NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF
NOT RECOGNIZED AND TREATED. 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. (5.3)
•INITIATION OF CYP3A4 INHIBITORS (OR DISCONTINUATION OF CYP3A4
INDUCERS) CAN RESULT IN A FATAL
OVERDOSE OF OXYCODONE FROM OXYCODONE HCL EXTENDED-RELEASE TABLETS .
(5.14)
RECENT MAJOR CHANGES
Boxed Warning
04/2014
Indications and Usage (1)
04/2014
Dosage and Admin