The full us prescribing information is available for download as a portable document format. Fentanyl citrate is chemically identified as n1phenethyl4piperidyl propionanilide citrate 1. Your doctor may, therefore, prescribe a higher dose of mylan fentanyl patch after some time to continue to give you pain relief. Composition and packaging section of the product monograph. Duragesic label page 1 full prescribing information for. This could lead to the rapid release of the contents of the duragesic patch and absorption of a potentially fatal dose of fentanyl. Because it takes a while for the fentanyl to work, the added amount from the previous patch will add to.
Each milliliter of solution contains fentanyl as the citrate 50 mcg 0. The new patch is designed as a translucent rectangular transdermal delivery system with rounded corners and a twopart scut on the adhesive side of the patch to enable system application. Fentanyl transdermal patch is a prescription medication thats used to treat chronic pain in opioidtolerant people. Capitals indicate lifethreatening, underlines indicate most frequent. Fentanyl sandoz should not be used concurrently with these medicines. The average volume of distribution for fentanyl is 6 lkg range 38. Instructions for use duragesic durahgeezik fentanyl transdermal system cii instructions for applying a duragesic patch be sure that you read, understand, and follow these instructions for use before you use duragesic.
Fentanyl sandoz should be initiated 14 days after cessation of maois. Fentanyl transdermal system contains fentanyl, an opioid agonist, and is indicated for the management of pain in opioidtolerant patients, severe enough to require daily, aroundtheclock, longterm opioid treatment and for which alternative treatment options are inadequate. The package insert for fentanyl patches states that fentanyl should only be used in patients who are already receiving opioid therapy, and who have demonstrated opioid tolerance. Do not remove the duragesic patch from the pouch until you are ready to use it see figure f. It may not seem that you are getting too much but it does catch up with you.
Make sure you have the right dose patch or patches that have been prescribed for you. Using damaged or cut duragesic patches can lead to the rapid release of the contents of the duragesic patch and absorption of a potentially fatal dose of fentanyl. Combination of these medicines with fentanyl sandoz patches may increase the risk of serotonin syndrome, a potentially lifethreatening condition. Duragesic label page 1 full prescribing information for use.
Duragesic patches are available in different 6 dosage strengths and patch sizes. The pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. Fentanyl accumulates in the skeletal muscle and fat and is released slowly into the blood. Instructions for use duragesic durahgeezik fentanyl. Assess patients risk before prescribing and monitor regularly for these behaviors and conditions.
Duragesic patch fentanyl patch rationale for inclusion in pa. They tell you this because you could recieve too much of the fentanyl. The use of fentanyl in opioid naive patients can result in serious sideeffects such as severe drowsiness and respiratory depression. Xulane may not be as effective in women weighing more than 198 lbs. Touch the sticky side of the duragesic patch as little as possible see figure g. Fentanyl belongs to a group of medicines called opioid analgesics. Duragesic label page 1 full prescribing information for use in. Assess patients risk before prescribing and monitor closely for. After 72 hours, there is still enough medication in the patch to cause serious harm to someone who is not using the fentanyl patch for pain control.
Mylan manufactures fentanyl transdermal system duragesic in strengths of 12 mcghr25 mcghr375 mcghr50 mcghr625 mcghr75 mcghr875 mcghr100 mcghr. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to overdose or death. Mar 02, 2020 fentanyl transdermal system contains fentanyl, an opioid agonist, and is indicated for the management of pain in opioidtolerant patients, severe enough to require daily, aroundtheclock, longterm opioid treatment and for which alternative treatment options are inadequate. Butrans buprenorphine transdermal system ciii official.
Patients may continue to require supplemental opioids for breakthroughpain. Fentanyl citrate injection is a sterile, nonpyrogenic, preservative free aqueous solution for intravenous or intramuscular injection. It works by blocking the nerves that recognise pain messages from the. Fentanyl patch is indicated for use in opioidtolerant patients. Fentanyl citrate injection, usp r x only description fentanyl citrate is a potent narcotic analgesic. Fentanyl novaplus patch fda prescribing information. The fentanyl transdermal system patch is used for the management of persistent, moderate to severe chronic pain in opioidtolerant patients when a continuous, aroundtheclock opioid analgesic. If 100mcghrisrequired,usemultipletransdermalsystems. Serious or lifethreatening breathing problems that can lead to death can. Fentanyl is released from the matrix at a nearly constant amount per unit time. Dosage and administration fentora fentanyl buccal tablet. Clinicians should use the fentanyl patch only if they are familiar with the prescribing information. Serious, lifethreatening, or fatal respiratory depression may occur. Remove a fentanyl transdermal system patch after wearing it for 3 days 72 hours see disposing of fentanyl transdermal system.
Package insert instructions must be followed accordingly. Mylan fentanyl patch with any other bandage or tape. Mylan fentanyl patch may lead to tolerance with continued or repeated use. Do not use a duragesic patch if the pouch seal is broken or the patch is cut, damaged or changed in any way. Through the tevafentanyl patch return program, you can engage and collaborate with your patients to ensure that tevafentanyl patches are used correctly and disposed of safely. Carefully peel this release liner off and throw the pieces away. Dispose of expired, unwanted, or unused duragesic by folding the patch so that the. The trust pain group has been informed of a number of situations where strong opioids and in particular fentanyl patches have been prescribed inappropriately. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl in urine. Fold the used patch in half so that the adhesive side sticks to. Opioid conversion table hop16091451 croni ain anaeen tooli calculating total daily doses of opioids is important to appropriately and effectively prescribe, manage, and taper opioid.
Fentanyl patches should only be prescribed to manage persistent, moderate tosevere chronic pain that requires continuous, aroundtheclock opiate administration for an extended period of time, particularly when the pain cannot. The concentration gradient existing between the matrix and the lower concentration in the skin drives drug release. Recommend an appropriate dose of transdermal fentanyl when. The matrix adheres directly to the skin without adhesive edges or layers. Assess patients risk before prescribing and monitor closely for these behaviors and conditions. Fentanyl equivalent ngml crossreactivity % fentanyl 2 2 100 4methoxybutryl fentanyl 3 2 77 acetyl fentanyl 4 2. Dec 12, 2019 fentanyl citrate injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Fentanyl is prescribed as intravenous anesthetic sublimaze, transdermal patch duragesic, and transmucosal lozenge form actiq. Describe the pharmacokinetics of transdermal fentanyl, and variables that can influence dosing. If the patch accidentally sticks to a family member while in close contact, take the patch off, wash the area with water, and get emergency help right away because an accidental exposure to duragesic. Do not apply the patch if it looks damaged in any way. Fentanyl patch protocol please use the following chart to determine whether or not the prescribed fentanyl dose is appropriate for your patient. The amount of fentanyl released per hour from each rectangular transparent patch is directly related to the surface area of the patch. Transdermal and parenteral fentanyl dosage calculations and.
Alterations in ph may affect its distribution between plasma and the central nervous system. Each patch contains 100fold more drug than what is stated on the label in order. Route onset peak duration fentanyltransdermal fentanil. Fentanyl plasma protein binding capacity decreases with increasing ionization of the drug. Transdermal and parenteral fentanyl dosage calculations. The high content of fentanyl in the patches duragesic. Butrans contains buprenorphine, a schedule iii controlled substance. Your doctor may prescribe additional pain relievers to control occasional outbreaks of pain. Polybutyltitanate, and durotak peelable release liner. Per the manufacturers, actavis, janssen duragesic, mylan, and sandoz, the fentanyl transdermal system does not contain any metal components that may present burn risks during mri personal communications. Fentanyl citrate injection is an opioid agonist indicated for. Fentanyl analytics in a case of fatal misuse of transdermal.
The fentanyl patch, also known by the brand name duragesic, is designed to give aroundtheclock pain relief to people experiencing chronic and severe pain. Duragesic is a longacting extendedrelease opioid pain medicine narcotic that can put you at risk for overdose and death. Through the tevafentanyl patch return program, you can engage and collaborate with your patients to ensure that tevafentanyl. Common questions and answers about fentanyl package insert. Fentanyl dose conversion guidelines current analgesic daily dosage mgd oral morphine 604 5224 225314 315404 imiv morphine 10 to. Butrans exposes users to the risks of opioid addiction, abuse, and misuse. Fentanyl transdermal system 901276 fentanyl transdermal system 12 mcghr 5 patchescarton duragesic ab 902576 fentanyl transdermal system 25 mcghr 5 patchescarton duragesic ab 905076 fentanyl transdermal system 50 mcghr 5 patchescarton duragesic ab 907576. Do not use the patch if it is cut, damaged, or altered in any way. The duragesic transdermal system patch is used for the management of persistent, moderate to.
Consult the package insert, your doctor, or your pharmacist for additional instructions on how to use the medication. Each duragesic patch has a clear plastic release liner that can be peeled off in two pieces. Route onset peak duration fentanyltransdermal fenta. Using mylan fentanyl patch fentanyl patch diagram not to scale each mylan fentanyl patch is packaged with an additional piece. Fentanyl transdermal system tds informational summary. Choose a different place on the skin to apply a new fentanyl transdermal system patch and repeat steps 2 through 6. Fentanyl novaplus patch fda prescribing information, side. Wash your hands when you have finished applying a fentanyl transdermal system patch. Switching from reservoir to matrix systems for the. Because extendedrelease products such as butrans deliver the opioid over an extended period of time, there is a greater risk for overdose and death, due to the larger amount of buprenorphine present.
Clinical pharmacology fentanyl citrate is a narcotic analgesic. Fentanyl transdermal system is a transdermal formulation of fentanyl indicated for the management of persistent, moderate to severe chronic pain in opioidtolerant patients 2 years of age and older when a continuous, aroundtheclock opioid analgesic is required for an extended period of time, and the patient cannot be managed by other means such. Fentanyl patch is being prescribed for pain severe enough to require daily, aroundtheclock, longterm treatment and the patient has been taking an opioid and the patient can safely take the requested dose based on their current opioid use history. The duragesic transdermal system patch is used for the management of persistent, moderate to severe chronic pain in opioidtolerant patients when a continuous, aroundtheclock opioid analgesic is needed for an extended period of time. Fentanyl transdermal patches have recently been associated with a number of serious adverse events and deaths nationwide. This letter provides clinicians with important information to promote the safe use of the fentanyl transdermal patch. Talk to your healthcare provider or pharmacist if you have any questions. Cha medication safety committee high alert medication.
Duragesic fentanyl transdermal system is a transdermal system providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. Each duragesic patch is sealed in its own protective pouch. Teva fentanyl is a skin patch that gradually delivers fentanyl through the skin into the bloodstream for 72 hours. It is an extendedrelease format that dispenses the powerful opioid drug in a transdermal fashion, or through the skin, continuously during a 72hour period. A patient who is on a total daily dose of 6 mg to 12 mg of oral rivastigmine can be switched to the 9. Instruct patients or caregivers to apply the first patch on the day following the last oral dose. At teva canada, were committed to safer communities and helping our customers. Use supplementaldosesof shortacting opioid analgesics to manage pain until relief is obtained with the transdermal system. Fentanyl patch protocol ventura county, california.
Instructions for use duragesic instructions for applying a. Peel off both parts of the protective liner from the patch. Each duragesic patch has a clear plastic protective liner that can be peeled off in two pieces. May 15, 2015 the pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug. Transdermal and parenteral fentanyl dosage calculations and conversions objectives after reading this chapter and completing all practice problems, the participant will be able to. Duragesic patches are intended for transdermal use on intact skin only. Fentanyl transdermal system duragesic 12 mcghr25 mcghr375.