Butrans Patch FDA prescribing information, side effects and uses. Generic Name buprenorphine. ADVISORIES/PublishingImages/Off%20label%20use%20of%20fentanyl%20patches%20Jun.jpg' alt='Fda Fentanyl Patch Regarding Safety Transdermal Use Warning' title='Fda Fentanyl Patch Regarding Safety Transdermal Use Warning' />Dosage Form patch, extended release. WARNING ADDICTION, ABUSE and MISUSE LIFE THREATENING RESPIRATORY DEPRESSION ACCIDENTAL EXPOSURE NEONATAL OPIOID WITHDRAWAL SYNDROME and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTSAddiction, Abuse, and Misuse. BUTRANS exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patients risk prior to prescribing BUTRANS, and monitor all patients regularly for the development of these behaviors and conditions see Warnings and Precautions 5. Overdosage 1. 0. Life Threatening Respiratory Depression. Serious, life threatening, or fatal respiratory depression may occur with use of BUTRANS. Monitor for respiratory depression, especially during initiation of BUTRANS or following a dose increase. Fentanyl+Transdermal+System.jpg' alt='Fda Fentanyl Patch Regarding Safety Transdermal Use Warning' title='Fda Fentanyl Patch Regarding Safety Transdermal Use Warning' />Butrans Patch official prescribing information for healthcare professionals. Includes indications, dosage, adverse reactions, pharmacology and more. Misuse or abuse of BUTRANS by chewing, swallowing, snorting or injecting buprenorphine extracted from the transdermal system will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death see Warnings and Precautions 5. Accidental Exposure. Accidental exposure to even one dose of BUTRANS, especially in children, can result in a fatal overdose of buprenorphine see Warnings and Precautions 5. Neonatal Opioid Withdrawal Syndrome. Prolonged use of BUTRANS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available see Warnings and Precautions 5. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants. Concomitant use of opioids with benzodiazepines or other central nervous system CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death see Warnings and Precautions 5. Drug Interactions 7. Reserve concomitant prescribing of BUTRANS and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. Indications and Usage for Butrans PatchBUTRANS is indicated for the management of pain severe enough to require daily, around the clock, long term opioid treatment and for which alternative treatment options are inadequate. Limitations of UseBecause of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risk of overdose and death with extended release opioid formulations see Warnings and Precautions 5. Find patient medical information for Fentanyl Transdermal on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. An+FDA+mandate+for+post-marketing+safety+strategies+are+becoming+common.jpg' alt='Fda Fentanyl Patch Regarding Safety Transdermal Use Warning' title='Fda Fentanyl Patch Regarding Safety Transdermal Use Warning' />BUTRANS for use in patients for whom alternative treatment options e. BUTRANS is not indicated as an as needed prn analgesic. Butrans Patch Dosage and Administration. Fda Fentanyl Patch Regarding Safety Transdermal Use Warning' title='Fda Fentanyl Patch Regarding Safety Transdermal Use Warning' />Important Dosage and Administration InformationBUTRANS 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. Patients who are opioid experienced are those receiving, for one week or longer, daily opioid doses up to 8. Use the lowest effective dosage for the shortest duration consistent with individual patients treatment goals see Warnings and Precautions 5. Initiate the dosing regimen for each patient individually, taking into account the patients severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse see Warnings and Precautions 5. Monitor patients closely for respiratory depression, especially within the first 2. BUTRANS see Warnings and Precautions 5. 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 avoid exposing BUTRANS to external heat sources, hot water, or prolonged direct sunlight see Warnings and Precautions 5. BUTRANS is for transdermal use on intact skin only. Each Butrans Patch is intended to be worn for 7 days. Initial DosageUse of BUTRANS as the First Opioid Analgesic opioid naive patientsInitiate treatment with BUTRANS with a 5 mcghour patch. Conversion from Other Opioids to BUTRANSDiscontinue 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 3. Oral Morphine Equivalents per Day Initiate treatment with BUTRANS 5 mcghour at the next dosing interval see Table 1 below, middle column. Prior Total Daily Dose of Opioid Between 3. Oral Morphine Equivalents per Day Taper the patients current around the clock opioids for up to 7 days to no more than 3. BUTRANS. Then initiate treatment with BUTRANS 1. 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 8. Oral Morphine Equivalents per Day BUTRANS 2. Consider the use of an alternate analgesic. Table 1 Initial BUTRANS DoseConversion from Methadone to BUTRANSClose 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. Titration and Maintenance of TherapyIndividually 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, as well as monitoring for the development of addiction, abuse, or misuse see Warnings and Precautions 5. Frequent communication is important among the prescriber, other members of healthcare team, the patient, and the caregiverfamily during periods of changing analgesic requirements, including initial titration. Network Connect 7.1.0 Free Download on this page. During chronic therapy, periodically reassess the continued need for opioid analgesics. The minimum BUTRANS titration interval is 7. Clinical Pharmacology 1. The maximum BUTRANS dose is 2. Do not exceed a dose of one 2. BUTRANS system due to the risk of QTc interval prolongation. In a clinical trial, BUTRANS 4. BUTRANS 2. 0 mcghour systems resulted in prolongation of the QTc interval see Warnings and Precautions 5. Clinical Pharmacology 1. How To Patch Up Concrete Driveway. 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. Because steady state plasma concentrations are achieved within 7. BUTRANS dosage may be adjusted every 3 days. Dose adjustments may be made in 5 mcghour, 7. The total dose from both patches should not exceed 2.