OXYCONTIN oxycodone hydrochloride tablet film coated extended release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Bryant Ranch Prepack

INN (Internationale Bezeichnung):

OXYCODONE HYDROCHLORIDE

Zusammensetzung:

OXYCODONE HYDROCHLORIDE 20 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

New Drug Application

Fachinformation

OXYCONTIN- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYCONTIN SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR OXYCONTIN.
OXYCONTIN (OXYCODONE HYDROCHLORIDE) 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; CYTOCHROME
P450 3A4
INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR
OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
RECENT MAJOR CHANGES
Box Warning
12/2016
Indications and Usage (1)
12/2016
Dosage and Administration (2)
12/2016
Warnings and Precautions (5)
12/2016
INDICATIONS AND USAGE
OXYCONTIN is an opioid agonist 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, reserve OXYCONTIN 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. (1)
OXYCONTIN is not indicated as an as-needed (prn) analgesic. (1)
DOSAGE AND ADMINISTRATION
To be prescribed only by healthcare providers knowledgeable in use of
potent opioids for management of chronic pain.
(2.1)
OXYCONTIN 60 mg and 80 mg tablets, a single dose greater than 40 mg,
or a total daily dose grea