OXYCONTIN- 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:

Rebel Distributors Corp

INN (International Name):

oxycodone hydrochloride

Composition:

oxycodone hydrochloride 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OxyContin is 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. Limitations of Usage OxyContin is not intended for use on an as-needed basis. OxyContin is not indicated for the management of pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. OxyContin is indicated for postoperative use following the immediate post-operative period only if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society guidelines). OxyContin is not indicated for pre-emptive analgesia (preoperative administration for the m

Product summary:

OxyContin (oxycodone hydrochloride controlled-release) Tablets 20 mg are 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 600 (NDC 42254-159-60 ). Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Dispense in tight, light-resistant container.

Authorization status:

New Drug Application

Patient Information leaflet

OXYCONTIN- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
Rebel Distributors Corp
----------
MEDICATION GUIDE
OXYCONTIN® (ox-e-KON-tin) CII
(oxycodone hydrochloride controlled-release)
Tablets
Read this Medication Guide before you start taking OxyContin and each
time you get a refill. There may
be new information. This Medication Guide does not take the place of
talking to your healthcare provider
about your medical condition or your treatment.
What is the most important information I should know about OxyContin?
•
OxyContin can cause serious side effects, including addiction or
death.
•
Do not cut, break, chew, crush, or dissolve OxyContin before
swallowing. If OxyContin is taken
in this way, the medicine in the tablets will be released too fast.
This is dangerous. It may cause
you to stop breathing, and may lead to death.
•
OxyContin is not for use to treat pain that you only have once in a
while ("as needed").
•
Do not take OxyContin 60 mg or 80 mg tablets unless you are "opioid
tolerant." Opioid tolerant
means that you regularly use OxyContin or another opioid medicine for
your constant (around-the-
clock) pain and your body is used to it.
•
Do not take more than 40 mg of OxyContin in one dose or more than 80
mg of OxyContin in one
day unless you are "opioid tolerant." This may cause you to stop
breathing and may lead to death.
•
OxyContin is a federally controlled substance (CII) because it is a
strong opioid pain medicine that
can be abused by people who abuse prescription medicines or street
drugs.
•
Prevent theft, misuse and abuse. Keep OxyContin in a safe place, to
keep it from being stolen.
OxyContin can be a target for people who misuse or abuse prescription
medicines or street drugs.
•
Never give OxyContin to anyone else, even if they have the same
symptoms you have. It may
harm them and even cause death.
•
Before taking OxyContin, tell your doctor if you or a family member
have been addicted to or
abused other medicines, street drugs, or alcohol, or if you have a
his

Summary of Product characteristics

OXYCONTIN- OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED
RELEASE
REBEL DISTRIBUTORS CORP
----------
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.
OXYCO NTIN (OXYCODONE HYDROCHLORIDE CONTROLLED-RELEASE) TABLETS CII
INITIAL U.S. APPROVAL: 1950
WARNING: IMPORTANCE OF PROPER PATIENT SELECTION AND POTENTIAL FOR
ABUSE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
OXYCONTIN CONTAINS OXYCODONE WHICH IS AN OPIOID AGONIST AND A SCHEDULE
II CONTROLLED SUBSTANCE WITH
AN ABUSE LIABILITY SIMILAR TO MORPHINE. (9)
OXYCONTIN IS 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.
(1)
OXYCONTIN IS NOT INTENDED FOR USE ON AN AS-NEEDED BASIS. (1)
OXYCONTIN 60 MG AND 80 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 TO AVOID FATAL
RESPIRATORY DEPRESSION. (2.7)
PATIENTS SHOULD BE ASSESSED FOR THEIR CLINICAL RISKS FOR OPIOID ABUSE
OR ADDICTION PRIOR TO BEING
PRESCRIBED OPIOIDS. (2.2)
OXYCONTIN TABLETS MUST BE SWALLOWED WHOLE AND MUST NOT BE CUT, BROKEN,
CHEWED, CRUSHED, OR
DISSOLVED WHICH CAN LEAD TO RAPID RELEASE AND ABSORPTION OF A
POTENTIALLY FATAL DOSE OF OXYCODONE. (2.1)
THE CONCOMITANT USE WITH CYTOCHROME P450 3A4 INHIBITORS SUCH AS
MACROLIDE ANTIBIOTICS AND PROTEASE
INHIBITORS MAY RESULT IN AN INCREASE IN OXYCODONE PLASMA
CONCENTRATIONS AND MAY CAUSE POTENTIALLY
FATAL RESPIRATORY DEPRESSION. (7.2)
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 11/2010
Warnings and Precautions (5.6)
10/2011
INDICATIONS AND USAGE
OxyContin is an opioid agonist indicated for:
Management of moderate to severe pain when a continuous,
around-the-clock opioid analgesic is needed for an
extended period of time. (1)
Not for use on an as-needed basis or in the immediate post-operative
period. (1)
DOSAGE AND