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:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

OXYCODONE HYDROCHLORIDE

Composition:

OXYCODONE HYDROCHLORIDE 40 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 - Known o

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 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 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

Lake Erie Medical DBA Quality Care Products LLC
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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 health

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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 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 Adminis