Butrans

Butrans Manufacturers

• Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
  

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  Butrans | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

  

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  2.1  General Principles

  Selection of patients for treatment with Butrans is governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment in every case, using non-opioid analgesics, opioids on an as-needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society, and Federation of State Medical Boards Model Policy.

  Butrans is for transdermal use (on intact skin) only.

  Do not use Butrans if the pouch seal is broken or the patch is cut, damaged, or changed in any way. Do not cut Butrans.

  Each Butrans is intended to be worn for 7 days.

  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 [see Clinical Pharmacology (12.3)].

  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 on at a different skin site [see How Supplied/Storage and Handling (16)].

  2.2  Initiation of Therapy

  It is critical to initiate the dosing regimen individually for each patient. Overestimating the Butrans dose when converting patients from another opioid medication can result in fatal overdose with the first dose [see Overdosage (10)]. Consider the following when selecting the initial dose of Butrans:

  The total daily dose, potency, and specific characteristics of the opioid the patient has been taking previously; The reliability of the relative potency estimate used to calculate the equivalent buprenorphine dose needed (when converting from other opioids or opioid-combination products); The patient’s degree of tolerance to the respiratory-depressant and sedating effects of opioids; The age, general condition, and medical status of the patient; Concurrent non-opioid analgesic and other medications; The type and severity of the patient's pain; The balance between pain control and adverse drug experiences; Risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion.

  The following dosing recommendations, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

  Opioid-Naïve Patients
  For opioid-naïve patients, initiate treatment with Butrans 5 mcg/hour. Thereafter, individually titrate the dose as described in Section 2.3 Dose Titration to a level that provides adequate analgesia and minimizes side effects. Dose may be titrated to the next higher level after a minimum of 72 hours.

  Conversion from Other Opioids to Butrans
  There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids. For conversion from other opioids to Butrans (see Table 1), taper the patient’s current around-the-clock opioids for up to 7 days to no more than 30 mg of morphine or equivalent per day before beginning treatment with Butrans. Patients may use short-acting analgesics as needed until analgesic efficacy with Butrans is attained.

  For patients whose daily dose was less than 30 mg of oral morphine or equivalent, initiate treatment with Butrans 5 mcg/hour. For patients whose daily dose was between 30 and 80 mg morphine equivalents, initiate treatment with Butrans 10 mcg/hour (see Table 1). Thereafter, individually titrate the dose as described in Section 2.3 Dose Titration.

  Table 1: Dose Estimation for Conversion of Oral Morphine Equivalents to Butrans Current Opioid Analgesic Current Daily Dose Oral Morphine Equivalent <30 mg 30-80 mg   Recommended Butrans Starting Dose 5 mcg/hour 10 mcg/hour

  Use caution when prescribing Butrans to opioid-experienced patients requiring high doses of opioids (more than 80 mg/day of oral morphine equivalents). Butrans 20 mcg/hour may not provide adequate analgesia for patients requiring greater than 80 mg/day oral morphine equivalents.

  2.3  Dose Titration

  Based on the patient’s requirement for supplemental short-acting analgesics, upward titration may be instituted with a minimum Butrans titration interval of 72 hours, based on the pharmacokinetic profile and time to reach steady state levels [see Clinical Pharmacology (12.3)]. Individually titrate the dose, under close supervision, to a level that provides adequate analgesia with tolerable side effects.

  The maximum Butrans dose is 20 mcg/hour. Do not exceed a dose of one 20 mcg/hour Butrans system due to the risk of QTc interval prolongation. In a clinical trial, Butrans 40 mcg/hour (given as two Butrans 20 mcg/hour systems) resulted in prolongation of the QTc interval [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.2)].

  During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between the prescriber, other members of the healthcare team, the patient, and the caregiver/family. Advise patients and caregivers/family members of the potential side effects.

  2.4  Maintenance of Therapy and Supplemental Analgesia

  The intent of the titration period is to establish a patient-specific weekly Butrans dose that will maintain adequate analgesia with tolerable side effects for as long as pain management is necessary. Immediate-release opioid and non-opioid medications can be used as supplemental analgesia during Butrans therapy.

  During chronic opioid analgesic therapy with Butrans, reassess the continued need for around-the-clock opioid analgesic therapy periodically.

  2.5  Cessation of Therapy

  When the patient no longer requires therapy with Butrans, taper the dose gradually to prevent signs and symptoms of withdrawal in the physically dependent patient; consider introduction of an appropriate immediate-release opioid medication. Undertake discontinuation of therapy as part of a comprehensive treatment plan.

  2.6  Patients with Hepatic Impairment

  Start patients with mild to moderate hepatic impairment with the Butrans 5 mcg/hour dose. Thereafter, individually titrate the dose to a level that provides adequate analgesia and tolerable side effects, under the close supervision of the prescriber. Butrans has not been evaluated in patients with severe hepatic impairment. As Butrans is only intended for 7-day application, consider use of an alternate analgesic that may permit more flexibility with the dosing in patients with severe hepatic impairment [see Warnings and Precautions (5.1), Use In Specific Populations (8.6), and Clinical Pharmacology (12.3)].

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• A-s Medication Solutions Llc
  

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  Butrans | A-s Medication Solutions Llc

  

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  2.1 Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with BUTRANS [see Warnings and Precautions (5.2)]. Overestimating the BUTRANS dose when converting patients from another opioid medication can result in fatal overdose with the first dose [see Overdosage (10)].

  Consider the following factors when selecting an initial dose of BUTRANS:

  Total daily dose, potency, and any prior opioid the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of buprenorphine needed (Note: potency estimates may vary with the route of administration); Patient's degree of opioid experience and opioid tolerance; General condition and medical status of the patient; Concurrent medication; Type and severity of the patient's pain.

  BUTRANS is for transdermal use (on intact skin) only. Each BUTRANS 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.

  BUTRANS as the First Opioid Analgesic
  Initiate treatment with BUTRANS 5 mcg/hour.

  Conversion from Other Opioids to BUTRANS
  There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids.

  Prior Total Daily Dose of Opioid Less than 30 mg of Oral Morphine Equivalents per Day:
  Initiate treatment with BUTRANS 5 mcg/hour.

  Prior Total Daily Dose of Opioid Between 30 mg to 80 mg of Oral Morphine Equivalents per Day:
  Taper the patient’s current around-the-clock opioids for up to 7 days to no more than 30 mg of morphine or equivalent per day before beginning treatment with BUTRANS. Then initiate treatment with BUTRANS 10 mcg/hour. Patients may use short-acting analgesics as needed until analgesic efficacy with BUTRANS is attained.

  Prior Total Daily Dose of Opioid Greater than 80 mg of Oral Morphine Equivalents per Day:
  BUTRANS 20 mcg/hour may not provide adequate analgesia for patients requiring greater than 80 mg/day oral morphine equivalents. Consider the use of an alternate analgesic.

  Table 1: Initial BUTRANS Dose

  Current Opioid Analgesic Current Daily Dose Oral Morphine Equivalent <30 mg 30-80 mg   Recommended BUTRANS Starting Dose 5 mcg/hour 10 mcg/hour 2.2 Titration and Maintenance of Therapy

  Individually titrate BUTRANS to a dose that provides adequate analgesia and minimizes adverse reactions. The minimum BUTRANS titration interval is 72 hours, based on the pharmacokinetic profile and time to reach steady state levels [see Clinical Pharmacology (12.3)].

  The maximum BUTRANS dose is 20 mcg/hour. Do not exceed a dose of one 20 mcg/hour BUTRANS system due to the risk of QTc interval prolongation. In a clinical trial, BUTRANS 40 mcg/hour (given as two BUTRANS 20 mcg/hour systems) resulted in prolongation of the QTc interval [see Warnings and Precautions (5.7), and Clinical Pharmacology (12.2)].

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the BUTRANS dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 72 hours, BUTRANS dosage adjustments may be done every 3 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication with an appropriate dose of an immediate-release opioid or non-opioid medication.

  If signs of excessive opioid-related adverse reactions are observed, the current patch may be removed or next dose may be reduced. Adjust the dose to obtain an appropriate balance between the management of pain and opioid-related adverse reactions.

  2.3 Cessation of Therapy

  When the patient no longer requires therapy with BUTRANS, use a gradual downward titration of the dose every 7 days to prevent signs and symptoms of withdrawal in the physically dependent patient; consider introduction of an appropriate immediate-release opioid medication. Do not abruptly discontinue BUTRANS.

  2.4 Patients with Hepatic Impairment

  BUTRANS has not been evaluated in patients with severe hepatic impairment. As BUTRANS is only intended for 7-day application, consider use of an alternate analgesic that may permit more flexibility with the dosing in patients with severe hepatic impairment [see Warnings and Precautions (5.10), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

  2.5 Administration of BUTRANS

  Instruct patients to apply immediately after removal from the individually sealed pouch. Instruct patients not to use BUTRANS if the pouch seal is broken or the patch is cut, damaged, or changed in any way.

  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 [see Clinical Pharmacology (12.3)].

  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 on at a different skin site.

  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 Patch-Disposal Unit provided and then disposed of in the trash. Never throw BUTRANS away in the trash without sealing it in the Patch-Disposal Unit.

  See the Instructions for Use for step-by-step instructions for applying BUTRANS.

  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.

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• Purdue Pharma Lp
  

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  Butrans | Purdue Pharma Lp

  

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  2.1 Initial Dosing

  BUTRANS should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  BUTRANS doses of 7.5, 10, 15, and 20 mcg/hour are for opioid-experienced patients only.

  Initiate the dosing regimen for each patient individually; take into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with BUTRANS [see Warnings and Precautions (5.2)].

  BUTRANS is for transdermal use (on intact skin) only. Each BUTRANS patch 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.

  Use of BUTRANS as the First Opioid Analgesic
  Initiate treatment with BUTRANS with a 5 mcg/hour patch.

  Conversion from Other Opioids to BUTRANS
  Discontinue all other around-the-clock opioid drugs when BUTRANS therapy is initiated.

  There is a potential for buprenorphine to precipitate withdrawal in patients who are already on opioids.

  Prior Total Daily Dose of Opioid Less than 30 mg of Oral Morphine Equivalents per Day:
  Initiate treatment with BUTRANS 5 mcg/hour at the next dosing interval (see Table 1 below, middle column).

  Prior Total Daily Dose of Opioid Between 30 mg to 80 mg of Oral Morphine Equivalents per Day:
  Taper the patient’s current around-the-clock opioids for up to 7 days to no more than 30 mg of morphine or equivalent per day before beginning treatment with BUTRANS. Then initiate treatment with BUTRANS 10 mcg/hour at the next dosing interval (see Table 1 below, right column). Patients may use short-acting analgesics as needed until analgesic efficacy with BUTRANS is attained.

  Prior Total Daily Dose of Opioid Greater than 80 mg of Oral Morphine Equivalents per Day:
  BUTRANS 20 mcg/hour may not provide adequate analgesia for patients requiring greater than 80 mg/day oral morphine equivalents. Consider the use of an alternate analgesic.

  
  

  Table 1: Initial BUTRANS Dose

  Previous Opioid Analgesic Daily Dose
  (Oral Morphine Equivalent) <30 mg 30-80 mg   Recommended BUTRANS Starting Dose 5 mcg/hour 10 mcg/hour

  Conversion from Methadone to BUTRANS
  Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.

  2.2 Titration and Maintenance of Therapy

  Individually titrate BUTRANS to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving BUTRANS to assess the maintenance of pain control and the relative incidence of adverse reactions, and monitor for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics.

  The minimum BUTRANS titration interval is 72 hours, based on the pharmacokinetic profile and time to reach steady state levels [see Clinical Pharmacology (12.3)].

  The maximum BUTRANS dose is 20 mcg/hour. Do not exceed a dose of one 20 mcg/hour BUTRANS system due to the risk of QTc interval prolongation. In a clinical trial, BUTRANS 40 mcg/hour (given as two BUTRANS 20 mcg/hour systems) resulted in prolongation of the QTc interval [see Warnings and Precautions (5.7) and Clinical Pharmacology (12.2)].

  If the level of pain increases, attempt to identify the source of increased pain, while adjusting the BUTRANS dose to decrease the level of pain. Because steady-state plasma concentrations are achieved within 72 hours, BUTRANS dosage may be adjusted every 3 days. Dose adjustments may be made in 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour increments by using no more than two patches of the 5 mcg/hour, 7.5 mcg/hour, or 10 mcg/hour system(s). The total dose from both patches should not exceed 20 mcg/hour. For the use of two patches, patients should be instructed to remove their current patch, and apply the two new patches at the same time, adjacent to one another at a different application site [see Dosage and Administration (2.5)].

  Patients who experience breakthrough pain may require dosage adjustment increase of BUTRANS, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the BUTRANS dose.

  If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between the management of pain and opioid-related adverse reactions.

  2.3 Cessation of Therapy

  When the patient no longer requires therapy with BUTRANS, use a gradual downward titration of the dose every 7 days to prevent signs and symptoms of withdrawal in the physically dependent patient; consider introduction of an appropriate immediate-release opioid medication. Do not abruptly discontinue BUTRANS.

  2.4 Patients with Hepatic Impairment

  BUTRANS has not been evaluated in patients with severe hepatic impairment. As BUTRANS is only intended for 7-day application, consider use of an alternate analgesic that may permit more flexibility with the dosing in patients with severe hepatic impairment [see Warnings and Precautions (5.10), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

  2.5 Administration of BUTRANS

  Instruct patients to apply immediately after removal from the individually sealed pouch. Instruct patients not to use BUTRANS if the pouch seal is broken or the patch is cut, damaged, or changed in any way. See the Instructions for Use for step-by-step instructions for applying BUTRANS.

  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 [see Clinical Pharmacology (12.3)].

  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.

  Incidental exposure of the BUTRANS patch to water, such as while bathing or showering is acceptable based on experience during clinical studies.

  If problems with adhesion of BUTRANS occur, the edges may be taped with first aid tape. If problems with lack of adhesion continue, the patch may be covered with waterproof or semipermeable adhesive dressings suitable for 7 days of wear.

  If BUTRANS falls off during the 7-day dosing interval, dispose of the transdermal system properly and place a new BUTRANS patch on at a different skin site.

  When changing the system, instruct patients to remove BUTRANS and dispose of it properly [see Dosage and Administration (2.6)].

  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.

  2.6 Disposal Instructions

  Patients should refer to the Instructions for Use for proper disposal of BUTRANS. Dispose of used and unused patches by following the instructions on the Patch-Disposal Unit that is packaged with the BUTRANS patches.

  Alternatively, patients can dispose of used patches by folding the adhesive side of the patch to itself, then flushing the patch down the toilet immediately upon removal. Unused patches should be removed from their pouches, the protective liners removed, the patches folded so that the adhesive side of the patch adheres to itself, and immediately flushed down the toilet.

  Patients should dispose of any patches remaining from a prescription as soon as they are no longer needed.

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