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:

Lake Erie Medical DBA Quality Care Products LLC

INN (Internationale Bezeichnung):

oxycodone hydrochloride

Zusammensetzung:

oxycodone 40 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

New Drug Application

Fachinformation

OXYCONTIN- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
OXYCONTIN
(OXYCODONE HCL CONTROLLED-RELEASE) TABLETS CII
10 MG 15 MG 20 MG 30 MG 40 MG 60 MG* 80 MG* 160 MG*
* 60 MG, 80 MG, AND 160 MG FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
WARNING:
OXYCONTIN CONTAINS OXYCODONE WHICH IS AN OPIOID AGONIST AND A SCHEDULE
II CONTROLLED
SUBSTANCE WITH AN ABUSE LIABILITY SIMILAR TO MORPHINE.
OXYCONTIN CAN BE ABUSED IN A MANNER SIMILAR TO OTHER OPIOID AGONISTS,
LEGAL OR ILLICIT. THIS
SHOULD BE CONSIDERED WHEN PRESCRIBING OR DISPENSING OXYCONTIN IN
SITUATIONS WHERE THE
PHYSICIAN OR PHARMACIST IS CONCERNED ABOUT AN INCREASED RISK OF
MISUSE, ABUSE, OR
DIVERS ION.
OXYCONTIN TABLETS ARE A CONTROLLED-RELEASE ORAL FORMULATION OF
OXYCODONE HYDROCHLORIDE
INDICATED FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN WHEN A
CONTINUOUS, AROUND-THE-
CLOCK OPIOID ANALGESIC IS NEEDED FOR AN EXTENDED PERIOD OF TIME.
OXYCONTIN TABLETS ARE NOT INTENDED FOR USE ON AN AS NEEDED BASIS.
PATIENTS CONSIDERED OPIOID TOLERANT ARE THOSE WHO ARE TAKING AT LEAST
60 MG ORAL
MORPHINE/DAY, 25 MCG TRANSDERMAL FENTANYL/HOUR, 30 MG ORAL
OXYCODONE/DAY, 8 MG ORAL
HYDROMORPHONE/DAY, 25 MG ORAL OXYMORPHONE/DAY, OR AN EQUIANALGESIC
DOSE OF ANOTHER
OPIOID FOR ONE WEEK OR LONGER.
OXYCONTIN 60 MG, 80 MG, AND 160 MG TABLETS, A SINGLE DOSE GREATER THAN
40 MG, OR A TOTAL
DAILY DOSE GREATER THAN 80 MG ARE ONLY FOR USE IN OPIOID-TOLERANT
PATIENTS, AS THEY MAY CAUSE
FATAL RESPIRATORY DEPRESSION WHEN ADMINISTERED TO PATIENTS WHO ARE NOT
TOLERANT TO THE
RESPIRATORY-DEPRESSANT OR SEDATING EFFECTS OF OPIOIDS.
PERSONS AT INCREASED RISK FOR OPIOID ABUSE INCLUDE THOSE WITH A
PERSONAL OR FAMILY HISTORY OF
SUBSTANCE ABUSE (INCLUDING DRUG OR ALCOHOL ABUSE OR ADDICTION) OR
MENTAL ILLNESS (E.G.,
MAJOR DEPRESSION). PATIENTS SHOULD BE ASSESSED FOR THEIR CLINICAL
RISKS FOR OPIOID ABUSE OR
ADDICTION PRIOR TO BEING PRESCRIBED OPIOIDS. ALL PATIENTS RECEIVING
OPIOIDS SHOULD BE
ROUTINELY MONITORED FOR SIGNS OF MISUSE, ABUSE A