Butrans buprenorphine 7 day patch—15 mcg/hour dose

Butrans Offers Multiple
Application Sites

Patient Savings Program for Butrans

Administration of Butrans

Butrans is for transdermal use (on intact skin) only. Each Butrans Transdermal System is intended to be worn for 7 days.
When discussing appropriate application practices with patients, be sure to tell them the following:

  • Do not use Butrans if the pouch seal is broken or the patch is cut, damaged, or changed in any way, and do not cut Butrans
  • Apply Butrans immediately after it is removed from the individually sealed pouch
  • Apply Butrans to the upper outer arm, upper chest, upper back or the side of the chest. These 4 sites (each present on both sides of the body) provide 8 possible application sites. Rotate Butrans among the 8 described skin sites. After Butrans removal, wait a minimum of 21 days before reapplying to the same skin site
4 locations on either side of the body provide 8 possible application sites for Butrans
  • Apply Butrans to a hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped, not shaven. Do not apply Butrans to irritated skin. If the application site must be cleaned, clean the site with water only. Do not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before applying Butrans
  • If problems with adhesion of Butrans occur, the edges may be taped with first aid tape. If Butrans falls off during the 7 days dosing interval, dispose of the transdermal system properly and place a new Butrans Transdermal System on at a different skin site
  • If the buprenorphine-containing adhesive matrix accidentally contacts the skin, instruct patients or caregivers to wash the area with water and not to use soap, alcohol, or other solvents to remove the adhesive because they may enhance the absorption of the drug
  • See the Instructions for Use for step-by-step instructions for applying Butrans

Proper disposal

  • When changing the system, instruct patients to remove Butrans, fold it over on itself, and flush it down the toilet. Alternatively, Butrans can be sealed in the system-disposal unit provided and then disposed of in the trash. Never throw Butrans away in the trash without sealing it in the system-disposal unit
  • See the Instructions for Use for step-by-step instructions for disposing Butrans
4 pouches, each containing a transdermal system 1 envelope, containing 4 disposal units
4 pouches, each containing
a Transdermal System
(not shown at actual size)
1 envelope containing
4 disposal units

Butrans® (buprenorphine) is indicated for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use: Butrans is not for use: as an
as-needed (prn) analgesic; for pain that is mild or not expected to persist for an extended period of time; for acute pain; for postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time.

Please read Important Safety Information, including Boxed Warning.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE POTENTIAL,
LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential
Butrans contains buprenorphine, an opioid agonist and Schedule III controlled substance with an abuse liability similar to other Schedule III opioids, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient's risk for opioid abuse or addiction prior to prescribing Butrans. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depressive disorder). Routinely monitor all patients receiving Butrans for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of Butrans, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and Butrans should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of Butrans or following a dose increase.

Accidental Exposure
Accidental exposure to Butrans, especially in children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.3)].

ADMINISTRATION OF BUTRANS

  • Butrans is for transdermal use (on intact skin) only. Each Butrans Transdermal System is intended to be worn for 7 days

  • Instruct patients not to use Butrans if the pouch seal is broken or the patch is cut, damaged, or changed in any way and not to cut Butrans

  • Instruct patients to apply immediately after removal from the individually sealed pouch

  • Apply Butrans to the upper outer arm, upper chest, upper back or the side of the chest. These 4 sites (each present on both sides of the body) provide 8 possible application sites. Rotate Butrans among the 8 described skin sites. After Butrans removal, wait a minimum of 21 days before reapplying to the same skin site

  • Apply Butrans to a hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped, not shaven. Do not apply Butrans to irritated skin. If the application site must be cleaned, clean the site with water only. Do not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before applying Butrans

  • If problems with adhesion of Butrans occur, the edges may be taped with first aid tape. If Butrans falls off during the 7 days dosing interval, dispose of the transdermal system properly and place a new Butrans Transdermal System on at a different skin site

  • If the buprenorphine-containing adhesive matrix accidentally contacts the skin, instruct patients or caregivers to wash the area with water and not to use soap, alcohol, or other solvents to remove the adhesive because they may enhance the absorption of the drug

  • See the Instructions for Use for step-by-step instructions for applying Butrans

CONTRAINDICATIONS

  • Butrans is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected paralytic ileus; hypersensitivity (eg, anaphylaxis) to buprenorphine

WARNINGS AND PRECAUTIONS

  • Abuse Potential: Butrans contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioid agonists, legal or illicit. Assess each patient's risk for opioid abuse or addiction prior to prescribing Butrans. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction. Routinely monitor all patients receiving opioids for signs of abuse, misuse, and addiction because these drugs carry a risk for addiction even under appropriate medical use

  • Misuse or abuse of Butrans by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of the opioid and pose a significant risk that could result in overdose and death

  • Life-Threatening Respiratory Depression: Respiratory depression is the primary risk of Butrans. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with a "sighing" pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids

  • While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Butrans, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with Butrans and following dose increases. Instruct patients against use by individuals other than the patient for whom Butrans was prescribed and to keep Butrans out of the reach of children, as such inappropriate use may result in fatal respiratory depression

  • To reduce the risk of respiratory depression, proper dosing and titration of Butrans are essential. Overestimating the Butrans dose when converting patients from another opioid product can result in fatal overdose with the first dose. Respiratory depression has also been reported with use of modified-release opioids when used as recommended and not misused or abused

  • Accidental Exposure: Accidental exposure to Butrans, especially in children, can result in a fatal overdose of buprenorphine

  • Elderly, Cachectic, and Debilitated Patients: Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. Monitor such patients closely, particularly when initiating and titrating Butrans and when Butrans is given concomitantly with other drugs that depress respiration

  • Use in Patients with Chronic Pulmonary Disease: Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with Butrans, as in these patients, even usual therapeutic doses of Butrans may decrease respiratory drive to the point of apnea. Consider the use of alternative non-opioid analgesics in these patients if possible

  • Interactions with Alcohol, CNS Depressants, and Illicit Drugs: Hypotension, profound sedation, coma, or respiratory depression may result if Butrans is added to a regimen that includes other CNS depressants (eg, sedatives, anxiolytics, hypnotics, neuroleptics, muscle relaxants, other opioids). Assess the duration of use of the CNS depressant and the patient's response, including the degree of tolerance that has developed to CNS depression. Consider the patient's use, if any, of alcohol or illicit drugs that cause CNS depression

  • If Butrans therapy is to be initiated in a patient taking a CNS depressant, start with a lower Butrans dose than usual and monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant

  • QTc Prolongation: A positive-controlled study of the effects of Butrans on the QTc interval in healthy subjects demonstrated no clinically meaningful effect at a Butrans Transdermal System dose of 10 mcg/hour; however, a Butrans Transdermal System dose of 40 mcg/hour (given as two Butrans 20 mcg/hour Transdermal Systems) was observed to prolong the QTc interval

  • Consider these observations in clinical decisions when prescribing Butrans to patients with hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia. Avoid the use of Butrans in patients with a history of Long QT Syndrome or an immediate family member with this condition, or those taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone, dofetilide)

  • Hypotensive Effects: Butrans may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has been compromised by reduced blood volume or concurrent administration of certain CNS depressant drugs. Monitor these patients for signs of hypotension after initiating or titrating the dose of Butrans

  • Use in Patients with Head Injury or Increased Intracranial Pressure: Monitor patients taking Butrans who may be susceptible to the intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with Butrans. Butrans may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury

  • Avoid the use of Butrans in patients with impaired consciousness or coma

  • Hepatotoxicity: Although not observed in Butrans chronic pain clinical trials, cases of cytolytic hepatitis and hepatitis with jaundice have been observed in individuals receiving sublingual buprenorphine for the treatment of opioid dependence, both in clinical trials and through post-marketing adverse event reports. For patients at increased risk of hepatotoxicity, obtain baseline liver enzyme levels and monitor periodically and during treatment with Butrans

  • Application Site Skin Reactions: In rare cases, severe application site skin reactions with signs of marked inflammation including "burn," "discharge," and "vesicles" have occurred. Time of onset varies, ranging from days to months following the initiation of Butrans treatment. Instruct patients to promptly report the development of severe application site reactions and discontinue therapy

  • Anaphylactic/Allergic Reactions: Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience. The most common signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. A history of hypersensitivity to buprenorphine is a contraindication to the use of Butrans

  • Application of External Heat: Advise patients and their caregivers to avoid exposing the Butrans application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, saunas, hot tubs, and heated water beds while wearing the system because an increase in absorption of buprenorphine may occur. Advise patients against exposure of the Butrans application site and surrounding area to hot water or prolonged exposure to direct sunlight. There is a potential for temperature-dependent increases in buprenorphine released from the system resulting in possible overdose and death

  • Patients with Fever: Monitor patients wearing Butrans systems who develop fever or increased core body temperature due to strenuous exertion for opioid side effects and adjust the Butrans dose if signs of respiratory or central nervous system depression occur

  • Use in Patients with Gastrointestinal Conditions: Butrans is contraindicated in patients with paralytic ileus. Avoid the use of Butrans in patients with other GI obstruction. The buprenorphine in Butrans may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Opioids may cause increases in the serum amylase

  • Use in Patients with Convulsive or Seizure Disorders: The buprenorphine in Butrans may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during Butrans therapy

  • Avoidance of Withdrawal: Symptoms of withdrawal include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Significant fluid losses from vomiting and diarrhea can require intravenous fluid administration

  • When discontinuing Butrans, gradually taper the dose. Do not abruptly discontinue Butrans

  • Driving and Operating Machinery: Butrans may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Butrans and know how they will react to the medication

  • Use in Addiction Treatment: Butrans has not been studied and is not approved for use in the management of addictive disorders

ADVERSE REACTIONS

  • Most common adverse reactions (≥5%) reported by patients treated with Butrans in clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash

Please read the Full Prescribing Information, including Boxed Warning.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.
Intended for healthcare professionals of the United States of America only. ©2013 Purdue Pharma L.P., Stamford, CT 06901-3431

Parentheses refer to sections in the Full Prescribing Information.

Important Safety Information

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential
Butrans contains buprenorphine, an opioid agonist and Schedule III controlled substance with an abuse liability similar to other Schedule III opioids, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient's risk for opioid abuse or addiction prior to prescribing Butrans. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depressive disorder). Routinely monitor all patients receiving Butrans for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of Butrans, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and Butrans should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of Butrans or following a dose increase.

Accidental Exposure
Accidental exposure to Butrans, especially in children, can result in a fatal overdose of buprenorphine [see Warnings and Precautions (5.3)].

Parentheses refer to sections in the Full Prescribing Information.

Administration of Butrans

  • Butrans is for transdermal use (on intact skin) only. Each Butrans Transdermal System is intended to be worn for 7 days

  • Instruct patients not to use Butrans if the pouch seal is broken or the patch is cut, damaged, or changed in any way and not to cut Butrans

  • Instruct patients to apply immediately after removal from the individually sealed pouch

  • Apply Butrans to the upper outer arm, upper chest, upper back or the side of the chest. These 4 sites (each present on both sides of the body) provide 8 possible application sites. Rotate Butrans among the 8 described skin sites. After Butrans removal, wait a minimum of 21 days before reapplying to the same skin site

  • Apply Butrans to a hairless or nearly hairless skin site. If none are available, the hair at the site should be clipped, not shaven. Do not apply Butrans to irritated skin. If the application site must be cleaned, clean the site with water only. Do not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before applying Butrans

  • If problems with adhesion of Butrans occur, the edges may be taped with first aid tape. If Butrans falls off during the 7 days dosing interval, dispose of the transdermal system properly and place a new Butrans Transdermal System on at a different skin site

  • If the buprenorphine-containing adhesive matrix accidentally contacts the skin, instruct patients or caregivers to wash the area with water and not to use soap, alcohol, or other solvents to remove the adhesive because they may enhance the absorption of the drug

  • See the Instructions for Use for step-by-step instructions for applying Butrans

CONTRAINDICATIONS

  • Butrans is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; known or suspected paralytic ileus; hypersensitivity (eg, anaphylaxis) to buprenorphine

WARNINGS AND PRECAUTIONS

  • Abuse Potential: Butrans contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioid agonists, legal or illicit. Assess each patient's risk for opioid abuse or addiction prior to prescribing Butrans. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depression). Patients at increased risk may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction. Routinely monitor all patients receiving opioids for signs of abuse, misuse, and addiction because these drugs carry a risk for addiction even under appropriate medical use

  • Misuse or abuse of Butrans by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of the opioid and pose a significant risk that could result in overdose and death

  • Life-Threatening Respiratory Depression: Respiratory depression is the primary risk of Butrans. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with a "sighing" pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids

  • While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Butrans, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with Butrans and following dose increases. Instruct patients against use by individuals other than the patient for whom Butrans was prescribed and to keep Butrans out of the reach of children, as such inappropriate use may result in fatal respiratory depression

  • To reduce the risk of respiratory depression, proper dosing and titration of Butrans are essential. Overestimating the Butrans dose when converting patients from another opioid product can result in fatal overdose with the first dose. Respiratory depression has also been reported with use of modified-release opioids when used as recommended and not misused or abused

  • Accidental Exposure: Accidental exposure to Butrans, especially in children, can result in a fatal overdose of buprenorphine

  • Elderly, Cachectic, and Debilitated Patients: Respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. Monitor such patients closely, particularly when initiating and titrating Butrans and when Butrans is given concomitantly with other drugs that depress respiration

  • Use in Patients with Chronic Pulmonary Disease: Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with Butrans, as in these patients, even usual therapeutic doses of Butrans may decrease respiratory drive to the point of apnea. Consider the use of alternative non-opioid analgesics in these patients if possible

  • Interactions with Alcohol, CNS Depressants, and Illicit Drugs: Hypotension, profound sedation, coma, or respiratory depression may result if Butrans is added to a regimen that includes other CNS depressants (eg, sedatives, anxiolytics, hypnotics, neuroleptics, muscle relaxants, other opioids). Assess the duration of use of the CNS depressant and the patient's response, including the degree of tolerance that has developed to CNS depression. Consider the patient's use, if any, of alcohol or illicit drugs that cause CNS depression

  • If Butrans therapy is to be initiated in a patient taking a CNS depressant, start with a lower Butrans dose than usual and monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant

  • QTc Prolongation: A positive-controlled study of the effects of Butrans on the QTc interval in healthy subjects demonstrated no clinically meaningful effect at a Butrans Transdermal System dose of 10 mcg/hour; however, a Butrans Transdermal System dose of 40 mcg/hour (given as two Butrans 20 mcg/hour Transdermal Systems) was observed to prolong the QTc interval

  • Consider these observations in clinical decisions when prescribing Butrans to patients with hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia. Avoid the use of Butrans in patients with a history of Long QT Syndrome or an immediate family member with this condition, or those taking Class IA antiarrhythmic medications (eg, quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (eg, sotalol, amiodarone, dofetilide)

  • Hypotensive Effects: Butrans may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has been compromised by reduced blood volume or concurrent administration of certain CNS depressant drugs. Monitor these patients for signs of hypotension after initiating or titrating the dose of Butrans

  • Use in Patients with Head Injury or Increased Intracranial Pressure: Monitor patients taking Butrans who may be susceptible to the intracranial effects of CO2 retention (eg, those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with Butrans. Butrans may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury

  • Avoid the use of Butrans in patients with impaired consciousness or coma

  • Hepatotoxicity: Although not observed in Butrans chronic pain clinical trials, cases of cytolytic hepatitis and hepatitis with jaundice have been observed in individuals receiving sublingual buprenorphine for the treatment of opioid dependence, both in clinical trials and through post-marketing adverse event reports. For patients at increased risk of hepatotoxicity, obtain baseline liver enzyme levels and monitor periodically and during treatment with Butrans

  • Application Site Skin Reactions: In rare cases, severe application site skin reactions with signs of marked inflammation including "burn," "discharge," and "vesicles" have occurred. Time of onset varies, ranging from days to months following the initiation of Butrans treatment. Instruct patients to promptly report the development of severe application site reactions and discontinue therapy

  • Anaphylactic/Allergic Reactions: Cases of acute and chronic hypersensitivity to buprenorphine have been reported both in clinical trials and in the post-marketing experience. The most common signs and symptoms include rashes, hives, and pruritus. Cases of bronchospasm, angioneurotic edema, and anaphylactic shock have been reported. A history of hypersensitivity to buprenorphine is a contraindication to the use of Butrans

  • Application of External Heat: Advise patients and their caregivers to avoid exposing the Butrans application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, saunas, hot tubs, and heated water beds while wearing the system because an increase in absorption of buprenorphine may occur. Advise patients against exposure of the Butrans application site and surrounding area to hot water or prolonged exposure to direct sunlight. There is a potential for temperature-dependent increases in buprenorphine released from the system resulting in possible overdose and death

  • Patients with Fever: Monitor patients wearing Butrans systems who develop fever or increased core body temperature due to strenuous exertion for opioid side effects and adjust the Butrans dose if signs of respiratory or central nervous system depression occur

  • Use in Patients with Gastrointestinal Conditions: Butrans is contraindicated in patients with paralytic ileus. Avoid the use of Butrans in patients with other GI obstruction. The buprenorphine in Butrans may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Opioids may cause increases in the serum amylase

  • Use in Patients with Convulsive or Seizure Disorders: The buprenorphine in Butrans may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during Butrans therapy

  • Avoidance of Withdrawal: Symptoms of withdrawal include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Significant fluid losses from vomiting and diarrhea can require intravenous fluid administration

  • When discontinuing Butrans, gradually taper the dose. Do not abruptly discontinue Butrans

  • Driving and Operating Machinery: Butrans may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Butrans and know how they will react to the medication

  • Use in Addiction Treatment: Butrans has not been studied and is not approved for use in the management of addictive disorders

ADVERSE REACTIONS

  • Most common adverse reactions (≥5%) reported by patients treated with Butrans in clinical trials were nausea, headache, application site pruritus, dizziness, constipation, somnolence, vomiting, application site erythema, dry mouth, and application site rash

Please read the Full Prescribing Information, including Boxed Warning.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.
Intended for healthcare professionals of the United States of America only. ©2013 Purdue Pharma L.P., Stamford, CT 06901-3431