OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet, film coated, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570)

Tersedia dari:

Lake Erie Medical DBA Quality Care Products LLC

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

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 55700-437-30 OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) 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 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) 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 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS (oxycodone hydrochloride) 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  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 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

Status otorisasi:

New Drug Application

Selebaran informasi

OXYCODONE HYDROCHLORIDE- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED,
EXTENDED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
OXYCODONE Hydrochloride (ox-e-KO-don hye-droe-KLOR-ide)
Extended-release Tablets, for oral use,
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.
•
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 i

Karakteristik produk

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 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 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, 12.3)
RECENT MAJOR CHANGES
Indications and Usage (1)
08/2015
Dosage and Administration (2) 08/2015