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