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Terms of Use for Butrans.com

The information provided on this Internet Web site ("Site") is for general informational and educational purposes only. Please read and review these Terms of Use carefully before accessing or using this Site. By accessing or using this Site, you acknowledge that you have read, understood and agreed to these Terms of Use. If you do not agree to the Terms of Use, do not access or use the site. "Purdue," as used in these Terms of Use means Purdue Pharma L.P., a participating company in a network of independent associated companies.


  1. COPYRIGHT AND TRADEMARK NOTICE

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  2. RESTRICTIONS ON USING THE CONTENT OF THIS WEBSITE

    Purdue makes no representation regarding the availability, the accuracy, or the completeness of the content of this Site. The Site contains information about products that may or may not be available in a particular country or region of the world, may be available under different trademarks in different countries and, where applicable, may be approved by government regulatory authority for sale or use with different indications and restrictions in different countries.

    This Site may contain, from time to time, information related to various health, medical and fitness conditions and their treatment. For non-healthcare providers, such information is not intended to be a substitute for the advice provided by a physician or other medical professional. You should not use the information contained herein for diagnosing a health or fitness problem or disease. In any event, users of this Site should always consult a doctor and/or other medical professional with respect to health concerns.

    While Purdue uses reasonable efforts to include accurate and up-to-date information in its Site, Purdue makes no warranties or representations as to its accuracy. Purdue assumes no liability or responsibility for any errors or omissions in the content of its Site. This Site may provide links or references to other Web sites not affiliated with Purdue. Such links to other Sites are provided only as a convenience to users of this Site. Purdue has not reviewed all of the Sites that may be linked to its Site, and is not responsible for the content of any other Site linked to this Site. Linking to any pages off this Site is at your own risk. Purdue shall not be liable for any damages or injury arising from users' access to such Sites.

    If in the event the Site provides visitors with an opportunity to post messages, you shall not post or transmit any unlawful, threatening, libelous, defamatory, obscene, inflammatory, pornographic or profane material or material that could constitute or encourage conduct that would be considered a criminal offense, give rise to civil liability, or would otherwise violate the law. Purdue shall not be responsible for content posted to its site by third parties. Purdue respects the privacy of its Site users. Please refer to Purdue's Privacy Policy which explains how information that is disclosed on this Site will be handled.

  3. INDEMNIFICATION BY SITE USER

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  4. LIMITATION OF LIABILITY

    Purdue provides the contents of its Site for informational purposes and for your general interest and entertainment only. By using the Site you hereby agree not to rely on any of the information contained herein. UNDER NO CIRCUMSTANCES SHALL PURDUE BE LIABLE FOR YOUR RELIANCE ON ANY SUCH INFORMATION NOR SHALL PURDUE BE LIABLE FOR DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, ANY DIRECT, INCIDENTAL, SPECIAL CONSEQUENTIAL, INDIRECT OR PUNITIVE DAMAGES THAT RESULT FROM THE USE OF, OR THE INABILITY TO USE, THE MATERIALS IN THIS SITE OR THE MATERIALS IN ANY SITE WHICH MAY BE LINKED TO THIS SITE, EVEN IF PURDUE OR A PURDUE AUTHORIZED REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. APPLICABLE LAW MAY NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY OR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. IN NO EVENT SHALL PURDUE'S TOTAL LIABILITY TO YOU FOR ALL DAMAGES, LOSSES, AND CAUSES OF ACTION WHETHER THE CAUSE OF ACTION IS IN CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE) OR OTHERWISE EXCEED THE AMOUNT PAID BY YOU, IF ANY, FOR ACCESSING THIS SITE.

  5. DISCLAIMER OF WARRANTIES

    THE MATERIALS IN THIS SITE ARE PROVIDED "AS IS" AND WITHOUT WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, PURDUE DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. PURDUE DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE MATERIALS WILL BE UNINTERRUPTED OR ERROR-FREE, THAT DEFECTS WILL BE CORRECTED, OR THAT THIS SITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. PURDUE DOES NOT WARRANT OR MAKE ANY REPRESENTATIONS REGARDING THE USE OR THE RESULTS OF THE USE OF THE MATERIALS IN THESE SITES IN TERMS OF THEIR CORRECTNESS, ACCURACY, RELIABILITY, OR OTHERWISE. YOU (AND NOT PURDUE) ASSUME THE ENTIRE COST OF ALL NECESSARY SERVICING, REPAIR OR CORRECTION. APPLICABLE LAW MAY NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO THE ABOVE EXCLUSION MAY NOT APPLY TO YOU.

  6. JURISDICTIONAL ISSUES/EXPORT RESTRICTIONS

    This Site is controlled and operated by Purdue from its offices within the State of Connecticut, United States of America. Although the Internet is global in nature, the laws regulating the manner in which pharmaceutical companies convey medical or product information are not. Each country has its own set of rules, regulations and laws. As a result, information intended for dissemination in a particular country may not be appropriate for use outside that country. The information on this Site is designed to comply with the laws of the United States. The information on this Site is intended for access and use by U.S. residents only. These Terms of Use shall be governed by and construed in accordance with the laws of the State of Connecticut, without giving effect to any principles of conflicts of law. If any provision of these Terms of Use shall be unlawful, void, or for any reason unenforceable, then that provision shall be deemed severable from these Terms of Use and shall not affect the validity and enforceability of any remaining provisions. This is the entire Agreement between the parties relating to the subject matter herein.

    This Site may link to other Sites produced by companies related to Purdue, some of which are outside the U.S. Those Sites may have information that is appropriate only to the particular originating country or region where the Site is based. You should not construe anything on the Site as a promotion or solicitation for any product or for the use of any product that is not authorized by the laws and regulations of the country where you are located. Purdue makes no representation that materials in the Site are appropriate or available for use in other locations. Those who choose to access this Site from other locations do so on their own initiative and are responsible for compliance with local laws, if and to the extent local laws are applicable.

    Software from this Site is further subject to United States export controls. No software from this Site may be downloaded or otherwise exported or re-exported (i) into (or to a national or resident of) Cuba, Iraq, Libya, North Korea, Iran, Syria or any other country subject to United States export control restrictions; or (ii) to anyone on the U.S. Treasury Department's list of Specially Designated Nationals or the U.S. Commerce Department's Table of Denial Orders. By downloading or using the Software, you represent and warrant that you are not located in, under the control of, or a national or resident of any such country or on any such list.

  7. CAREER AND/OR BUSINESS OPPORTUNITIES

    The Site displays information about job postings ("Current Openings") for informational purposes only. This information is subject to change without notice, and in displaying such information Purdue makes no representation or warranty that the information contained on the Site will be timely or free of errors and omissions.

    It is the intent of Purdue to leave you with absolute control over the decision to forward your personal information or resume to the company. It is your choice to give Purdue your personal information via the Internet, Fax or Mail.

    Under no circumstances, should you use this Site or any of the fax and mailing addresses on the Site to send Purdue confidential or proprietary information. Purdue does not want to receive such confidential or proprietary information. Any information deemed not personally identifiable and deemed not subject to our Privacy Policy, including questions, comments, ideas, and suggestions shall be deemed to be non-confidential, and Purdue shall be free to disclose and/or use the same, without obligations whatsoever towards you, for any purpose whatsoever and through any means whatsoever.

    Although accessible by others, the intent of Purdue in displaying Current Openings on this Site is to display employment opportunities within the United States of America. You should not construe anything on the Site as a promotion or solicitation for employment not authorized by the laws and regulations of the country where you are located.

  8. LINKING POLICY

    Links Out — This Site may provide links or references to other Web sites not affiliated with Purdue. Purdue has not reviewed the content of Web sites that may be linked to its Site, makes no representations about the content of the Web sites, and is not responsible for the content of any other Web site linked to this Site. Linking to any pages off this Site is at your own risk. Purdue shall not be liable for any damages or injury arising from users' access to such Web sites.

    Links In — Unless otherwise set forth in a written agreement between you and Purdue, you must adhere to Purdue's linking policy as follows: i) any link to a Purdue Site must be a text only link clearly marked with the name of the specific Purdue Web site, ii) the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with Purdue's name or trademarks, iii) the link must point to one of the specific Purdue Web site URLs homepage and not to other pages within the Web site, iv) the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, associated with, or affiliated with Purdue or the Site, v) when selected by the user, the link must display the Web site on full screen and not within a "frame" on the linking Website, and vi) the linked Web site must comply with all applicable U.S. laws, rules, and regulations. Purdue shall not be liable for any damages or injury arising from such Links In any Purdue Site.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING BREATHING PROBLEMS; ACCIDENTAL EXPOSURE; WITHDRAWAL SYNDROME IN NEWBORNS; and RISKS FROM USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Butrans is a long-acting (extended-release) opioid pain medicine that can put you and other users at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Life-Threatening Breathing Problems

When you first start using Butrans, or when your dose is increased, serious or life-threatening breathing problems that can lead to death may occur, and may occur even at recommended doses during the normal course of therapy. Do not chew, swallow, snort, or inject buprenorphine from the patch because this can lead to overdose and death.

Accidental Exposure

Accidental exposure, especially in children, may result in breathing problems, overdose, or death.

Withdrawal Syndrome in Newborns

Prolonged use of Butrans when you are pregnant can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated.

Use with Benzodiazepines or Other CNS Depressants

Use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, can result in severe drowsiness, breathing problems, coma and death.

What is Butrans?
  • Butrans is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments, such as non-opioid pain medicines (e.g., acetaminophen, ibuprofen, or celecoxib) or immediate-release opioid medicines, do not treat your pain well enough, you experience side effects when taking them, or they are deemed otherwise inadequate.

  • Butrans is only used to treat pain that continues around-the-clock (pain that is constant).

IMPORTANT SAFETY INFORMATION

Butrans is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse and misuse that can lead to death.

Do not use Butrans if you:

  • Have severe asthma, trouble breathing, or other lung problems

  • Have a bowel blockage or narrowing of the stomach or intestines

  • Are allergic to buprenorphine

Before applying Butrans, tell your healthcare provider if you have a history of head injury or seizures; problems breathing or urinating; liver, kidney, thyroid, pancreas, or gallbladder problems; heart rhythm abnormalities (Long QT Syndrome); abuse of street or prescription drugs; alcohol addiction; or mental health problems.

WARNINGS
  • Use of Butrans, even when used as recommended, can result in addiction, abuse and misuse, which could lead to overdose and death.

  • Get emergency help right away if you take too much Butrans (overdose).

  • The risk of serious or life-threatening breathing problems that could lead to death can occur even at recommended doses. The risk is greatest when you first start using Butrans or when your dose is increased. Patients who have lung disease or are elderly, frail, or in poor general health, are at increased risk, especially if Butrans is given with other drugs that cause breathing problems. Seek medical attention immediately if you have trouble breathing.

  • Taking Butrans with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Do not use these together unless you are directed to do so by your healthcare provider.

  • Never give anyone else your Butrans. They could die from using it. Store Butrans away from children and in a safe place to help prevent abuse or theft. Selling or giving away Butrans is against the law.

  • Accidental exposure, especially in a child, may result in breathing problems, overdose, or death. Be sure to store Butrans safely and to dispose of unused patches when Butrans is no longer needed; use the Patch-Disposal Unit or fold the patch in half and flush it down the toilet (see the detailed Instructions for Use provided with the Butrans patch).

  • Tell your healthcare provider if you are pregnant or planning to become pregnant. Prolonged use of Butrans while you are pregnant can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

  • Tell your healthcare provider if you are breastfeeding. Breastfeeding is not recommended during treatment with Butrans. It may harm your baby.

  • Tell your healthcare provider about any prescription or over-the-counter medicines, vitamins, or herbal supplements you are taking. Using Butrans with certain other medicines can cause serious side effects that could lead to death.

  • When using Butrans, do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Butrans may cause you to overdose and die.

  • Butrans could cause adrenal insufficiency, a potentially life-threatening condition which may cause symptoms of nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Seek medical attention if you experience these symptoms.

  • Butrans may cause symptoms of low blood pressure such as dizziness, lightheadedness, or fainting. If you experience these symptoms, you should sit or lie down and be careful when you get up from a sitting or lying position.

  • Butrans may complicate head injuries. Butrans should not be used by those with disturbances in consciousness or coma.

  • Do not stop using Butrans without talking to your healthcare provider.

  • Tell your healthcare provider if you develop a fever. While using Butrans, do NOT expose Butrans or the skin near where Butrans is applied to hot water or prolonged direct sunlight; avoid sunbathing, taking hot baths, hot tubs, saunas, heating pads, electric blankets, heated waterbeds, and heat or tanning lamps. These activities can increase the amount of medicine your Butrans delivers and cause an overdose that can lead to death.

  • Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

  • Butrans may increase the frequency of seizures in patients who experience seizures and may increase the risk of seizures in other settings associated with seizures. Tell your healthcare provider if you have a history of seizures.

  • When using Butrans, do not drive or operate heavy machinery until you know how Butrans affects you. Butrans can make you sleepy, dizzy, or lightheaded, and may reduce your mental and physical ability to perform these activities safely.

Side Effects
  • The most common side effects reported by patients treated with Butrans in the clinical trials were nausea, headache, application site itch, dizziness, constipation, sleepiness, vomiting, application site redness, dry mouth, and application site rash. Call your healthcare provider if you have any of these symptoms and they are severe.

  • These are not all the possible side effects of Butrans. Call your doctor for medical advice about side effects.

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

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

Indications and Usage
What is Butrans?
  • Butrans is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments, such as non-opioid pain medicines (e.g., acetaminophen, ibuprofen, or celecoxib) or immediate-release opioid medicines, do not treat your pain well enough, you experience side effects when taking them, or they are deemed otherwise inadequate.

  • Butrans is only used to treat pain that continues around-the-clock (pain that is constant).

Important Safety Information

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING BREATHING PROBLEMS; ACCIDENTAL EXPOSURE; WITHDRAWAL SYNDROME IN NEWBORNS; and RISKS FROM USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Butrans is a long-acting (extended-release) opioid pain medicine that can put you and other users at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Life-Threatening Breathing Problems

When you first start using Butrans, or when your dose is increased, serious or life-threatening breathing problems that can lead to death may occur, and may occur even at recommended doses during the normal course of therapy. Do not chew, swallow, snort, or inject buprenorphine from the patch because this can lead to overdose and death.

Accidental Exposure

Accidental exposure, especially in children, may result in breathing problems, overdose, or death.

Withdrawal Syndrome in Newborns

Prolonged use of Butrans when you are pregnant can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated.

Use with Benzodiazepines or Other CNS Depressants

Use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, can result in severe drowsiness, breathing problems, coma and death.

IMPORTANT SAFETY INFORMATION

Butrans is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse and misuse that can lead to death.

Do not use Butrans if you:

  • Have severe asthma, trouble breathing, or other lung problems

  • Have a bowel blockage or narrowing of the stomach or intestines

  • Are allergic to buprenorphine

Before applying Butrans, tell your healthcare provider if you have a history of head injury or seizures; problems breathing or urinating; liver, kidney, thyroid, pancreas, or gallbladder problems; heart rhythm abnormalities (Long QT Syndrome); abuse of street or prescription drugs; alcohol addiction; or mental health problems.

WARNINGS
  • Use of Butrans, even when used as recommended, can result in addiction, abuse and misuse, which could lead to overdose and death.

  • Get emergency help right away if you take too much Butrans (overdose).

  • The risk of serious or life-threatening breathing problems that could lead to death can occur even at recommended doses. The risk is greatest when you first start using Butrans or when your dose is increased. Patients who have lung disease or are elderly, frail, or in poor general health, are at increased risk, especially if Butrans is given with other drugs that cause breathing problems. Seek medical attention immediately if you have trouble breathing.

  • Taking Butrans with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Do not use these together unless you are directed to do so by your healthcare provider.

  • Never give anyone else your Butrans. They could die from using it. Store Butrans away from children and in a safe place to help prevent abuse or theft. Selling or giving away Butrans is against the law.

  • Accidental exposure, especially in a child, may result in breathing problems, overdose, or death. Be sure to store Butrans safely and to dispose of unused patches when Butrans is no longer needed; use the Patch-Disposal Unit or fold the patch in half and flush it down the toilet (see the detailed Instructions for Use provided with the Butrans patch).

  • Tell your healthcare provider if you are pregnant or planning to become pregnant. Prolonged use of Butrans while you are pregnant can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

  • Tell your healthcare provider if you are breastfeeding. Breastfeeding is not recommended during treatment with Butrans. It may harm your baby.

  • Tell your healthcare provider about any prescription or over-the-counter medicines, vitamins, or herbal supplements you are taking. Using Butrans with certain other medicines can cause serious side effects that could lead to death.

  • When using Butrans, do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Butrans may cause you to overdose and die.

  • Butrans could cause adrenal insufficiency, a potentially life-threatening condition which may cause symptoms of nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Seek medical attention if you experience these symptoms.

  • Butrans may cause symptoms of low blood pressure such as dizziness, lightheadedness, or fainting. If you experience these symptoms, you should sit or lie down and be careful when you get up from a sitting or lying position.

  • Butrans may complicate head injuries. Butrans should not be used by those with disturbances in consciousness or coma.

  • Do not stop using Butrans without talking to your healthcare provider.

  • Tell your healthcare provider if you develop a fever. While using Butrans, do NOT expose Butrans or the skin near where Butrans is applied to hot water or prolonged direct sunlight; avoid sunbathing, taking hot baths, hot tubs, saunas, heating pads, electric blankets, heated waterbeds, and heat or tanning lamps. These activities can increase the amount of medicine your Butrans delivers and cause an overdose that can lead to death.

  • Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

  • Butrans may increase the frequency of seizures in patients who experience seizures and may increase the risk of seizures in other settings associated with seizures. Tell your healthcare provider if you have a history of seizures.

  • When using Butrans, do not drive or operate heavy machinery until you know how Butrans affects you. Butrans can make you sleepy, dizzy, or lightheaded, and may reduce your mental and physical ability to perform these activities safely.

Side Effects
  • The most common side effects reported by patients treated with Butrans in the clinical trials were nausea, headache, application site itch, dizziness, constipation, sleepiness, vomiting, application site redness, dry mouth, and application site rash. Call your healthcare provider if you have any of these symptoms and they are severe.

  • These are not all the possible side effects of Butrans. Call your doctor for medical advice about side effects.

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

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

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING BREATHING PROBLEMS; ACCIDENTAL EXPOSURE; WITHDRAWAL SYNDROME IN NEWBORNS; and RISKS FROM USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

Butrans is a long-acting (extended-release) opioid pain medicine that can put you and other users at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Life-Threatening Breathing Problems

When you first start using Butrans, or when your dose is increased, serious or life-threatening breathing problems that can lead to death may occur, and may occur even at recommended doses during the normal course of therapy. Do not chew, swallow, snort, or inject buprenorphine from the patch because this can lead to overdose and death.

Accidental Exposure

Accidental exposure, especially in children, may result in breathing problems, overdose, or death.

Withdrawal Syndrome in Newborns

Prolonged use of Butrans when you are pregnant can cause withdrawal symptoms in your newborn baby that may be life-threatening if not recognized and treated.

Use with Benzodiazepines or Other CNS Depressants

Use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, can result in severe drowsiness, breathing problems, coma and death.

What is Butrans?
  • Butrans is a strong prescription pain medicine that contains an opioid (narcotic). It is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments, such as non-opioid pain medicines (e.g., acetaminophen, ibuprofen, or celecoxib) or immediate-release opioid medicines, do not treat your pain well enough, you experience side effects when taking them, or they are deemed otherwise inadequate.

  • Butrans is only used to treat pain that continues around-the-clock (pain that is constant).

IMPORTANT SAFETY INFORMATION

Butrans is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you use your dose correctly as prescribed, you are at risk for opioid addiction, abuse and misuse that can lead to death.

Do not use Butrans if you:

  • Have severe asthma, trouble breathing, or other lung problems

  • Have a bowel blockage or narrowing of the stomach or intestines

  • Are allergic to buprenorphine

Before applying Butrans, tell your healthcare provider if you have a history of head injury or seizures; problems breathing or urinating; liver, kidney, thyroid, pancreas, or gallbladder problems; heart rhythm abnormalities (Long QT Syndrome); abuse of street or prescription drugs; alcohol addiction; or mental health problems.

WARNINGS
  • Use of Butrans, even when used as recommended, can result in addiction, abuse and misuse, which could lead to overdose and death.

  • Get emergency help right away if you take too much Butrans (overdose).

  • The risk of serious or life-threatening breathing problems that could lead to death can occur even at recommended doses. The risk is greatest when you first start using Butrans or when your dose is increased. Patients who have lung disease or are elderly, frail, or in poor general health, are at increased risk, especially if Butrans is given with other drugs that cause breathing problems. Seek medical attention immediately if you have trouble breathing.

  • Taking Butrans with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Do not use these together unless you are directed to do so by your healthcare provider.

  • Never give anyone else your Butrans. They could die from using it. Store Butrans away from children and in a safe place to help prevent abuse or theft. Selling or giving away Butrans is against the law.

  • Accidental exposure, especially in a child, may result in breathing problems, overdose, or death. Be sure to store Butrans safely and to dispose of unused patches when Butrans is no longer needed; use the Patch-Disposal Unit or fold the patch in half and flush it down the toilet (see the detailed Instructions for Use provided with the Butrans patch).

  • Tell your healthcare provider if you are pregnant or planning to become pregnant. Prolonged use of Butrans while you are pregnant can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

  • Tell your healthcare provider if you are breastfeeding. Breastfeeding is not recommended during treatment with Butrans. It may harm your baby.

  • Tell your healthcare provider about any prescription or over-the-counter medicines, vitamins, or herbal supplements you are taking. Using Butrans with certain other medicines can cause serious side effects that could lead to death.

  • When using Butrans, do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Butrans may cause you to overdose and die.

  • Butrans could cause adrenal insufficiency, a potentially life-threatening condition which may cause symptoms of nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Seek medical attention if you experience these symptoms.

  • Butrans may cause symptoms of low blood pressure such as dizziness, lightheadedness, or fainting. If you experience these symptoms, you should sit or lie down and be careful when you get up from a sitting or lying position.

  • Butrans may complicate head injuries. Butrans should not be used by those with disturbances in consciousness or coma.

  • Do not stop using Butrans without talking to your healthcare provider.

  • Tell your healthcare provider if you develop a fever. While using Butrans, do NOT expose Butrans or the skin near where Butrans is applied to hot water or prolonged direct sunlight; avoid sunbathing, taking hot baths, hot tubs, saunas, heating pads, electric blankets, heated waterbeds, and heat or tanning lamps. These activities can increase the amount of medicine your Butrans delivers and cause an overdose that can lead to death.

  • Get emergency medical help if you have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

  • Butrans may increase the frequency of seizures in patients who experience seizures and may increase the risk of seizures in other settings associated with seizures. Tell your healthcare provider if you have a history of seizures.

  • When using Butrans, do not drive or operate heavy machinery until you know how Butrans affects you. Butrans can make you sleepy, dizzy, or lightheaded, and may reduce your mental and physical ability to perform these activities safely.

Side Effects
  • The most common side effects reported by patients treated with Butrans in the clinical trials were nausea, headache, application site itch, dizziness, constipation, sleepiness, vomiting, application site redness, dry mouth, and application site rash. Call your healthcare provider if you have any of these symptoms and they are severe.

  • These are not all the possible side effects of Butrans. Call your doctor for medical advice about side effects.

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

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

Please read the Brief Summary and Full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use.

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