OXYCODONE HCL- 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:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

oxycodone hydrochloride

Composition:

oxycodone hydrochloride 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OXYCODONE HCL EXTENDED-RELEASE TABLETS 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 OXYCODONE HCL EXTENDED-RELEASE TABLETS is 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 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 63304-683-01). 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 63304-684-01). 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

Patient Information leaflet

Ranbaxy Pharmaceuticals Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: April 2014
303377-0A
Medication Guide
Oxycodone 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 presc

Summary of Product characteristics

OXYCODONE HCL- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
RANBAXY PHARMACEUTICALS 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_.
•
•
•
•
•
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 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 RECOGNIZE