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:

Amneal Pharmaceuticals of New York LLC

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 in: - Adults; and - Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. 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 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) an

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 0115-1556-01). Oxycodone HCl Extended-Release Tablets 15 mg are film-coated, round, gray-colored, bi-convex tablets debossed with OP on one side and 15 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1557-01) 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 0115-1558-01) Oxycodone HCl Extended-Release Tablets 30 mg are film-coated, round, brown-colored, bi-convex tablets debossed with OP on one side and 30 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1559-01) 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 0115-1560-01) Oxycodone HCl Extended-Release Tablets 60 mg are film-coated, round, red-colored, bi-convex tablets debossed with OP on one side and 60 on the other and are supplied as child-resistant closure, opaque plastic bottles of 100 (NDC 0115-1561-01) 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 0115-1562-01) Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
Amneal Pharmaceuticals of New York LLC
----------
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.
•
Not for use in children less than 11 years of age and who are not
already using opioid pain
medicines regularly to manage pain severe enough to require daily
around-the-clock long-term
treatment of pain with an opioid.
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.
•
Taking oxycodone HCl extended-release tablets 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 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

Summary of Product characteristics

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED
RELEASE
AMNEAL PHARMACEUTICALS OF NEW YORK 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; RISK EVALUATION AND MITIGATION
STRATEGY
(REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION;
NEONATAL
OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; AND RISKS
FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
OXYCODONE HCL EXTENDED-RELEASE TABLETS EXPOSES USERS TO RISKS OF
ADDICTION, ABUSE AND MISUSE, WHICH
CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE
PRESCRIBING AND MONITOR REGULARLY FOR
THESE BEHAVIORS AND CONDITIONS. (5.1)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE, THE
FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED A RISK EVALUATION AND
MITIGATION STRATEGY (REMS)
FOR THESE PRODUCTS. (5.2)
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. (5.3)
ACCIDENTAL INGESTION OF OXYCODONE HCL EXTENDED-RELEASE TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF OXYCODONE. (5.3)
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
PROLONGED OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE
PATIENT OF THE RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND ENSURE THAT APPR