S Depressants
Inform patients that the concomitant use of alcohol with OPANA ER can increase the risk of life-threatening respiratory depression. Instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter drug products that contain alcohol, during treatment with OPANA ER.
Inform patients that potentially serious additive effects may occur if OPANA ER is used with other CNS depressants, and not to use such drugs unless supervised by a health care provider.
Important Administration Instructions
Instruct patients how to properly take OPANA ER, including the following:
Swallowing OPANA ER tablets whole
Not crushing, chewing, or dissolving the tablets
Occasionally, the inactive ingredients of OPANA ER may be eliminated as a soft mass in the stool that may resemble the original tablet. Patients should be informed that the active medication has already been absorbed by the time the patient sees the soft mass.
Using OPANA ER exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression)
Not discontinuing OPANA ER without first discussing the need for a tapering regimen with the prescriber
To take each tablet with enough water to ensure complete swallowing immediately after placing in mouth.
Hypotension
Inform patients that OPANA ER may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position).
Driving or Operating Heavy Machinery
Inform patients that OPANA ER may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication.
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention.
Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in OPANA ER. Advise patients how to recognize such a reaction and when to seek medical attention.
Pregnancy
Advise female patients that OPANA ER can cause fetal harm and to inform the prescriber if they are pregnant or plan to become pregnant.
Manufactured for:
Endo Pharmaceuticals Inc.
Chadds Ford, PA 19317
Manufactured by:
Pharmaceuticals Manufacturing Research Services Inc.
Horsham, PA 19044
INTAC® is a registered trademark of the Grünenthal Group
© 2012 Endo Pharmaceuticals
111690
Medication GuideOPANA®ER (Ō-pan-a)
(oxymorphone hydrochloride extended-release) Tablets, for oral use, CII
OPANA ER is:
A strong prescription pain medicine that contains an opioid (narcotic) that is used to treat moderate to severe around-the-clock pain.
Important information about OPANA ER:
Get emergency help right away if you take too much OPANA ER (overdose). OPANA ER overdose can cause life threatening breathing problems that can lead to death.
Never give anyone else your OPANA ER. They could die from taking it. Store OPANA ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away OPANA ER is against the law.
Do not take OPANA ER if you have:
severe asthma, trouble breathing, or other lung probl |
