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Terms of Use

BEFORE ACCESSING THIS SITE, PLEASE READ THE FOLLOWING TERMS AND CONDITIONS CAREFULLY AS THEY GOVERN YOUR USE OF THIS SITE. IF YOU DO NOT AGREE WITH THESE TERMS AND CONDITIONS, YOU ARE NOT GRANTED PERMISSION BY COVIDIEN TO ACCESS OR OTHERWISE USE THIS SITE.

User Agreement

Welcome to the KeepPainWaiting.com / EXALGO.com Web site (also referred to as the "Site") owned and operated by Mallinckrodt Pharmaceuticals. This Agreement contains the terms, covenants, conditions, and provisions (the "Terms and Conditions") upon which you, the User, may access and use this Site.

Terms and Conditions

By accessing, viewing, or using this Site, you indicate that you understand and intend these Terms and Conditions to be the legal equivalent of a signed, written contract and equally binding, and that you accept such Terms and Conditions and agree to be legally bound by them. Please note that Mallinckrodt Pharmaceuticals reserves the right to change these Terms and Conditions. Your continued use of this Site following such modifications will be conclusively deemed acceptance of any changes to these Terms and Conditions.

License Grant

This Agreement provides you with a personal, revocable, non-exclusive, non-transferable license to use this Site conditioned on your continued compliance with the Terms and Conditions of this Agreement. You may print and download materials and information on this Site solely for personal and non-commercial use, provided that all hard copies contain all copyright and other applicable notices contained in such materials and information. As a further condition of use of this Site, you warrant to Mallinckrodt Pharmaceuticals that you will not use this Site for any purpose that is unlawful or otherwise prohibited by these Terms and Conditions.

Intellectual Property Rights

All materials contained in the Site are protected by law, including but not limited to United States copyright, trade secret, and trademark law, as well as other state, national, and international laws. The contents of and all materials distributed in conjunction with the Site are Copyright © 2014 Mallinckrodt Pharmaceuticals. All rights reserved. Mallinckrodt Pharmaceuticals also owns a copyright in the Site as a collective work and/or compilation, and in the selection, coordination, arrangement, and enhancement of such content. Republication or citation of any other content generated by the Site without Mallinckrodt Pharmaceuticals' written consent is expressly prohibited. You agree not to copy, modify, adapt, frame, mirror, reproduce, translate, distribute, transmit, reverse engineer, decompile, or disassemble any aspect of the Site, except as expressly allowed by this Agreement. All product names, whether or not appearing in large print, italics or with the trademark symbol, are trademarks of Mallinckrodt Pharmaceuticals, its affiliates, related companies or its licensors or joint venture partners, and any use of such marks without the express written permission of Mallinckrodt Pharmaceuticals is strictly prohibited. Unauthorized use of any material contained on this Site may violate copyright laws, trademark laws, trade secret laws, the laws of privacy and publicity, and communications regulations and statutes. Please be aware that Mallinckrodt Pharmaceuticals actively and aggressively enforces its intellectual property rights to the fullest extent of the law.

Copyright Owners' Rights under the Digital Millennium Copyright Act of 1998

The Digital Millennium Copyright Act of 1998 (the "DMCA") provides recourse for copyright owners who believe that material appearing on the Internet infringes their rights under U.S. copyright law. If you believe in good faith that materials hosted by Mallinckrodt Pharmaceuticals infringes your copyright, then you (or your agent) may send us a notice requesting that the materials be removed, or access to them blocked. If you believe in good faith that a notice of copyright infringement has been wrongly filed against you, then the DMCA permits you to send us a counter-notice. Notices and counter-notices must meet statutory requirements imposed by the DMCA. One place to find more information on the DMCA is the U.S. Copyright Office web site. Notices and counter-notices for the Site should be sent to:

Mallinckrodt Pharmaceuticals
675 McDonnell Blvd.
Building 10-3-S
Hazelwood, MO 63042
Attention: Stuart Kim, J.D., Legal Department

Submissions

Mallinckrodt Pharmaceuticals welcomes your feedback and suggestions about how to improve this Site. Any ideas, suggestions, information, know-how, material, or other content (collectively, "content") received through this Site, however, will be deemed to include a royalty-free, perpetual, irrevocable, transferable, worldwide, non-exclusive right and license for Mallinckrodt Pharmaceuticals to adopt, publish, reproduce, disseminate, transmit, distribute, copy, use, create derivative works, display (in whole or part), or act on such content without additional approval or consideration, in any form, media, or technology now known or later developed for the full term of any rights that may exist in such content.

Jurisdiction

The information provided on this Site is intended for U.S. health care professionals and has been designed to comply with applicable U.S. regulations and guidance.

Disclaimer

Medical information that appears on this Site is for informational purposes only and is not, nor is intended to be, a medical diagnosis or a replacement for advice given by a licensed physician or other licensed health care professional. Any reliance on the information provided on this Site is solely the responsibility of the individual. While we make reasonable efforts to ensure the timeliness and accuracy of the materials present on this Site, Mallinckrodt Pharmaceuticals makes no assurances or warranties (express or implied) as to the accuracy of the information provided on this Site and shall not be liable for any direct, indirect, incidental, consequential or otherwise special damages or injuries resulting from the use of this Site and reliance on the materials contained here. Mallinckrodt Pharmaceuticals may make changes to these materials at any time, without notice, and makes no commitment to update the information contained herein.

This Site may link you to other Web sites that are not owned or controlled by Mallinckrodt Pharmaceuticals. Links are provided for your convenience only. These Web sites are maintained by entities over which Mallinckrodt Pharmaceuticals exercises no control. Accordingly, Mallinckrodt Pharmaceuticals expressly disclaims any responsibility for the content, the accuracy of the information and/or quality of products or services provided by or advertised on these third-party sites. If you choose to hyperlink to another Web site, then you do so at your own risk.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

EXALGO® (hydromorphone HCI) Extended-Release Tablets (CII)

USE

EXALGO® (hydromorphone HCI) Extended-Release Tablets (CII) is used to treat pain that is painful enough to need this type of medicine throughout the entire day in people who have been regularly taking similar pain medicines. EXALGO is an opioid (narcotic). It has risks of addiction, abuse, misuse, overdose, and death, even when taken at the dose your doctor prescribed. Because of this, EXALGO should be used only when other medicines don't work. EXALGO is not used as an as-needed pain reliever.

 

IMPORTANT RISK INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
BREATHING PROBLEMS; ACCIDENTAL USE; WITHDRAWAL SYNDROME IN NEWBORNS

Addiction, Abuse, and Misuse

Addiction, abuse, and misuse of EXALGO can lead to overdose and death.

Life-threatening Breathing Problems

EXALGO can cause severe breathing problems that can kill you. Crushing, chewing, or dissolving EXALGO can cause you to get too much medicine, which can kill you.

Accidental Use

Taking EXALGO by mistake can cause overdose and death, especially in children.

Withdrawal Syndrome in Newborns

Taking EXALGO while pregnant can cause withdrawal in your newborn baby. It may kill them if they are not treated.

DO NOT USE EXALGO IF:

  • You were not previously taking another opioid (narcotic) pain medicine.
  • You have severe asthma or other breathing problems.
  • You have a bowel blockage.
  • You have had previous surgeries or disease that caused your stomach or bowels to become narrower.
  • You are allergic to hydromorphone, sulfites, or any other ingredient.

WARNINGS:

  • EXALGO is a controlled substance. It has risks of abuse, misuse, and addiction like other opioid medicines used for pain. Crushing, chewing, snorting, or injecting EXALGO can cause overdose and death. Injecting the inactive ingredients in EXALGO can damage your heart, which can kill you. Drug abuse by injection can also cause the spread of diseases such as hepatitis and HIV (AIDS).
  • EXALGO can cause severe breathing problems that can kill you, even when it is used as your doctor prescribed. The risk of severe breathing problems is highest when you first start taking EXALGO or when your dose is increased. People who are elderly or who already have severe breathing problems have a higher chance of having severe breathing problems when they take EXALGO.
  • Low blood pressure, excessive sedation, severe breathing problems, and death can occur if you take EXALGO with certain other medicines. These include drugs to treat anxiety or help you sleep, similar pain medicines, or alcohol.
  • The use of EXALGO could result in low blood pressure.
  • EXALGO may complicate head injuries.
  • EXALGO may aggravate seizures in people who experience seizures.
  • Do not abruptly stop taking EXALGO.
  • EXALGO could affect your ability to drive a car, use machinery, or do other dangerous tasks.

SIDE EFFECTS:

  • Serious side effects include severe breathing problems which can kill you, overdose, and death.
  • The most common side effects are constipation, nausea, vomiting, drowsiness, headache, fatigue/lack of strength, and dizziness.

USE IN CERTAIN POPULATIONS:

  • Babies born to mothers who use opioids like EXALGO could have trouble breathing and symptoms of withdrawal.
  • EXALGO passes into breast milk. It may harm your baby if you breastfeed.
  • EXALGO is not approved for children.

 

Please see Medication Guide for Important Risk Information and Full Prescribing Information.

IMPORTANT RISK INFORMATION

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
BREATHING PROBLEMS; ACCIDENTAL USE; WITHDRAWAL SYNDROME IN NEWBORNS

Addiction, Abuse, and Misuse

Addiction, abuse, and misuse of EXALGO can lead to overdose and death. Click here for more Important Risk Information, including full boxed warning