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:

Sandoz 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS are contraindicated in patients with: Clinical Considerations Fetal/neonatal adverse reactions Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly [see Warnings and Precautions (5.3)] . Teratogenic Effects - Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. OXYCODONE HCl EXTENDED-RELEASE TABLETS should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Product summary:

OXYCODONE HCl 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 0781-5703-01 ). OXYCODONE HCl 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 0781-5726-01 ). OXYCODONE HCl 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 0781-5767-01 ). OXYCODONE HCl 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 0781-5785-01 ). 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

Sandoz Inc
----------
MEDICATION GUIDE
Oxycodone (OX-ee-KOH-dohn) HCl 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 problems
•
problems urinating
•
pancreas or
gallbladder
problems
•
abuse of street or
prescription drugs,
alcohol addiction, or
mental health
problems.
Tell your healthcare
provider if you are:
•
pre

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
SANDOZ 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._
•
•
•
•
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 Administration (2) 04/2014
Warnings and Precautions (5)
04/2014
INDICATIONS AND USAGE
OXYCODONE HCl EXTENDED-RELEASE TABLETS are an opioid agonist product
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
•
•
DOSAGE AND ADMINISTRATION
•
OXYCODONE HCL EXTENDED-RELEASE TABLETS EXPOSE 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 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