Application Information

This drug has been submitted to the FDA under the reference 019813/004.

Names and composition

"DURAGESIC-25" is the commercial name of a drug composed of FENTANYL.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
019813/004 DURAGESIC-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
019813/001 DURAGESIC-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG per HR
019813/002 DURAGESIC-75 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 75MCG per HR
019813/003 DURAGESIC-50 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 50MCG per HR
019813/004 DURAGESIC-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR
019813/005 DURAGESIC-12 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 12.5MCG per HR
076258/001 FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR
076258/002 FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 50MCG per HR
076258/003 FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 75MCG per HR
076258/004 FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG per HR
076258/005 FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 12.5MCG per HR
076258/006 FENTANYL-37 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 37.5MCG per HR
076258/007 FENTANYL-62 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 62.5MCG per HR
076258/008 FENTANYL-87 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 87.5MCG per HR
076709/001 FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR
076709/002 FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 50MCG per HR
076709/003 FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 75MCG per HR
076709/004 FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG per HR
077051/001 FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR
077051/002 FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 50MCG per HR
077051/003 FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 75MCG per HR
077051/004 FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG per HR
077062/001 FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR
077062/002 FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 50MCG per HR
077062/003 FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 75MCG per HR
077062/004 FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG per HR
077154/001 FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR
077154/002 FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 50MCG per HR
077154/003 FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 75MCG per HR
077154/004 FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG per HR
077154/005 FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 12.5MCG per HR
077449/001 FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR
077449/002 FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 50MCG per HR
077449/003 FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 75MCG per HR
077449/004 FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG per HR
077449/005 FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 12.5MCG per HR
077775/001 FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR
077775/002 FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 50MCG per HR
077775/003 FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 75MCG per HR
077775/004 FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG per HR
202097/001 FENTANYL-12 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 12.5MCG per HR
202097/002 FENTANYL-25 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 25MCG per HR
202097/003 FENTANYL-50 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 50MCG per HR
202097/004 FENTANYL-75 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 75MCG per HR
202097/005 FENTANYL-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG per HR
202577/001 FENTANYL FENTANYL TABLET/BUCCAL 100MCG
202577/002 FENTANYL FENTANYL TABLET/BUCCAL 200MCG
202577/003 FENTANYL FENTANYL TABLET/BUCCAL 300MCG
202577/004 FENTANYL FENTANYL TABLET/BUCCAL 400MCG
202577/005 FENTANYL FENTANYL TABLET/BUCCAL 600MCG
202577/006 FENTANYL FENTANYL TABLET/BUCCAL 800MCG
202788/001 SUBSYS FENTANYL SPRAY/SUBLINGUAL 0.1MG
202788/002 SUBSYS FENTANYL SPRAY/SUBLINGUAL 0.2MG
202788/003 SUBSYS FENTANYL SPRAY/SUBLINGUAL 0.4MG
202788/004 SUBSYS FENTANYL SPRAY/SUBLINGUAL 0.6MG
202788/005 SUBSYS FENTANYL SPRAY/SUBLINGUAL 0.8MG
202788/006 SUBSYS FENTANYL SPRAY/SUBLINGUAL 1.2MG
202788/007 SUBSYS FENTANYL SPRAY/SUBLINGUAL 1.6MG

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Answered questions

If your on celexa (the medication)......?
is there anything that your not supposed to combine with it? (like vitamins, certain foods, caffeine, anything?!) Asked by Irma Rodemeyer 1 year ago.

Medication (in alphabetical order); Major Interactions 5-HTP, 5-hydroxytryptophan, Actiq, Acutrim 16 Hour, Acutrim II, Maximum Strength, Acutrim Late Day, Adapin, Adipex-P, Adipost, Alfenta, alfentanil, almotriptan, Amerge, amitriptyline, amoxapine, amphetamine, Anafranil, Anorex-SR, Aplenzin, Appecon, Asendin, Atapryl, Aventyl HCl, Axert, Azilect, Babee Cof, Balminil DM, Balminil DM Pour Enfants, Balminil DM Sans Sucrose, Benadryl for the Family Dry Forte, Benylin, Benylin Adult Formula, Benylin DM, Benylin DM Pediatric, Benylin Dry Coughs, Benylin Pediatric, benzphetamine, Bisolvon Dry, Bisolvon Dry Junior, Bontril PDM, Bontril Slow Release, Buckley's Mixture Cough Suppressant, Buckleys Mixture, Budeprion SR, Budeprion XL, buPROPion, buPROPion 24 hour extended release, buPROPion extended release, BuSpar, BuSpar Dividose, busPIRone, Calmylin, Carbex, Chem Mart Tramadol, clomiPRAMINE, Contac Cough, Control, Cough Relief, Cough Syrup DM, Covonia Bronchial Balsam, Creo-Terpin, Creomulsion, Creomulsion Children, Cymbalta, D.H.E. 45, Darvon, Darvon-N, Delsym, Delsym 12 Hour Cough Relief, Delsym 12 Hour Cough Relief for Children & Adults, Demerol HCl, desipramine, Desoxyn, Desoxyn Gradumet, desvenlafaxine, Desyrel, Desyrel Dividose, DexAlone, Dexatrim, Dexatrim Caffeine Free, Dexedrine, Dexedrine Spansule, dexfenfluramine, Dexi-Tuss, dextroamphetamine, dextroamphetamine extended release, dextromethorphan, dextromethorphan extended release, Dextromethorphan HBr Adult Formula, Dextrostat, Didrex, diethylpropion, diethylpropion extended release, dihydroergotamine, dihydroergotamine nasal, Dimetapp Cold Cough & Flu Day & Night Liquid Caps, doxepin, doxepin topical, Dristan DM, Dromadol SR, Dromadol XL, Dry Cough, duloxetine, Duragesic, Duragesic-100, Duragesic-12, Duragesic-25, Duragesic-50, Duragesic-75, Effexor, Effexor XR, Elavil, Eldepryl, eletriptan, Elixsure Cough, Empro, Emsam, Endep, ephedra, Ergomar, ergotamine, Eskalith, Eskalith-CR, Fastin, fenfluramine, 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Nucosef DM, Obephen, Obezine, Oby-Cap, Oby-Trim, Omnipaque 140, Omnipaque 180, Omnipaque 180 Redi-Unit, Omnipaque 210, Omnipaque 240, Omnipaque 240 Redi-Unit, Omnipaque 300, Omnipaque 350, Omnipaque Flexipak, Orap, Orlaam, Pamelor, Panshape M, Parnate, Pedia Relief, Pediacare, pentazocine, Pertussin CS Childrens, Pertussin DM, Pertussin ES, Phendiet, Phendiet-105, phendimetrazine, phendimetrazine extended release, phenelzine, Phentercot, phentermine, phentermine hydrochloride, phentermine hydrochloride extended release, phentermine resin extended release, Phentride, Phenyldrine, phenylpropanolamine, pimozide, Plegine, Pondimin, PP-Cap, Prelu-2, Pristiq, Pro-Fast HS, Pro-Fast SA, Pro-Fast SR, procarbazine, Propagest, Propan, propoxyphene, propoxyphene hydrochloride, propoxyphene napsylate, protriptyline, Prudoxin, rasagiline, Redux, Relpax, Remeron, Remeron SolTab, remifentanil, Rhindecon, rizatriptan, Robafen Cough Liquidgels, Robafen Pediatric Cough & Cold, Robitussin Cough Calmers, Robitussin CoughGels, Robitussin Dry Cough, Robitussin DX Cough Control, Robitussin DX Cough Control Forte, Robitussin DX Dry Cough Forte, Robitussin Honey Cough, Robitussin Junior Persistent Cough, Robitussin Maximum Strength, Robitussin Pediatric Cough Long-Acting, Robitussin Pediatric Cough Suppressant, Robitussin Soft Pastilles, Ryzolt, Sanorex, Savella, Scot-Tussin Diabetic, Scot-Tussin DM Cough Chasers, selegiline, Selgene, Serzone, sibutramine, Silphen DM, Sinequan, sodium biphosphate, sodium oxybate, St. John's wort, St. Joseph Cough Suppressant, Statobex, Strepsils Cough, Strepsils Cough Relief, Sublimaze, Sucrets DM Cough, Sufenta, sufentanil, sumatriptan, sumatriptan nasal, Surmontil, T-Diet, Talwin, Talwin Lactate, Tenuate, Tenuate Dospan, Teramine, Teramine ER, Terry White Chemists Tramadol, Theraflu Thin Strips Cough, thioridazine, Tofranil, Tofranil-PM, traMADOL, traMADOL extended release, Tramahexal, Tramahexal SR, Tramake, Tramake Insts, Tramal, Tramal SR, Tramedo, tranylcypromine Answered by Magda Fanny 1 year ago.

There are no side effects at all. I have gone off of it several times and had no issues, although if you do decide to go back on, all that headache and stuff will come back. If the issue is not being able to pay for them I would like to suggest that i am taking a generic version of celexa called citralopram that only costs 20 dollars for 30 pills at 40mg. I hope i helped you, Answered by Deena Braulio 1 year ago.

Tramahexal Sr 100 Answered by Tressie Juliano 1 year ago.


Is switching from 20 to 30mgs of hydrocodone to 25mcg of fentanyl safe?
ive been takin 20 to 30 mgs of hydrocodone a day for the past two months recently my pain managment doctor has switched me to 25mcg/h fentanyl is this safe to take i havent taken it yet i keep takin my vicodin since ive read so many bad things about this medicine but my pain is not too tolarable on vicodin so if... Asked by Joannie Buglione 1 year ago.

ive been takin 20 to 30 mgs of hydrocodone a day for the past two months recently my pain managment doctor has switched me to 25mcg/h fentanyl is this safe to take i havent taken it yet i keep takin my vicodin since ive read so many bad things about this medicine but my pain is not too tolarable on vicodin so if someone can answer this it would b greatly appreciated thanx Answered by Sanford Skolnik 1 year ago.

To be frank no it is not exactly safe. There is one major issue with pain management and that is tolerance. A person is considered to be opioid tolerant at 60 mg of oral morphine (which is equivalent to 60 mg of oral hydrocodone). A person at a lower does is considered to be opioid-naïve. At that level you are able to take any of the full opioid agonists. People with little or no opioid tolerance can take an equivalent amount of most opioids EXCEPT for methadone and Duragesic (fentanyl transdermal system). 25 mcg/h of Duragesic is equal to 60-134 mg of oral morphine or hydrocodone per day. So you are at about half the dose you should be at. Fentanyl transdermal has multiple black box warning. A black box is the strongest level of caution and they are used if a drug has very significant risks. Basically all of the full opioid agonists like morphine, oxycodone, oxymorphone, hydromorphone, and methadone have at least 2-3 black box warnings- Duragesic has 7. Here is what one of the black box warnings says. This is taken DIRECTLY from the official Duragesic prescribing information: "DURAGESIC® is indicated for management of persistent, moderate to severe chronic pain that: • requires continuous, around-the-clock opioid administration for an extended period of time, and • cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids. DURAGESIC® should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid." Here is information from the official Duragesic (technically called Duragesic MAT in Canada) product monograph from Health Canada: "Initiation of DURAGESIC MAT in patients who are opioid-naïve is contraindicated at any dose. The initial dose of DURAGESIC MAT must not be higher than that dose which is equivalent to the total dose of opioids the patient is receiving at the time of the switch to the patch." There is nothing wrong with using Duragesic and a lot of people have excellent results. The issue is just the fact that you are still opioid-naïve. Also even if if would be safe for you to use Duragesic at this time it would skyrocket your tolerance. That means if you need a dose increase in the future instead of increasing the hydrocodone 10-20 mg you would likely require much more. So if you used Duragesic and then switched to morphine or hydrocodone and your tolerance had increased you may need 150 mg of either morphine or hydrocodone. And if 20-30 mg of hydrocodone is controlling your pain then I would not recommend moving to a VERY potent opioid like Duragesic. My advice would be to call your doctor (or make an appointment with him- bring the Duragesic) and talk about your concerns and alternatives. Is he a real pain specialist with a good reputation? Did your GP or another doctor refer you? You might ask about using MS Contin (morphine sulfate continuous-release). The nice thing about using a long acting opioid is that it keeps the level of medication fairly even (preventing drastic ups and downs), it only needs to be taken twice daily (every 12hrs) to provide pain relief 24/7. It is best to be using medication continuously with chronic pain and not taking medication as needed. Also MS Contin comes in 15 mg tablets and you would take two daily so you would be taking the exact equivalent of hydrocodone. You might find you need a bit higher dose when moving to a controlled-release drug but typically not by much. MS Contin is also MUCH cheaper (if that is an issue). Or Avinza, which is also morphine continuous-release but it typically only requires a single dose in 24hrs and it comes in 30 mg capsules (and 45 mg is you need a bit more). That might even be better. Also having some break threw pain medication like Vicodin, OxyIR (oxycodone instant release), or MS-IR (morphine instant release) is a good idea for times when your pain gets really bad. But I would get off The Vicodin. Drugs with acetaminophen mixed with an opioid are good for acute or intermittent pain but not great for chronic pain. UPDATE: Just FYI psychical dependence (a result of physiological changes in the body) is NOT addiction. Here is some vocab that is commonly misunderstood, even by doctors. Addiction (psychological dependence): • Primary, chronic, neurobiologic disease influenced by genetic, psychosocial, and environmental factors. • Characterized by one or more of the following behaviours: loss of control over drug use, continued use despite harm, and craving. • The technical terms for addiction are either substance dependence (DSM-IV) or dependence syndrome (ICD-10). Using the term dependence is generally considered to mean addiction. Physical dependence: Adaptive state manifested by a withdrawal syndrome caused by: abrupt cessation, antagonist administration, decreasing drug-blood levels, rapid dose reduction. Alone physical dependence is NOT addiction. Legitimate medical use of opioids, benzodiazepines, or barbiturates commonly cause physical dependence. Tolerance: Adaptive state where continued drug exposure results in a need for markedly increased amounts of the substance to achieve the desired effect and/or markedly diminished effect with use of the same amount of the substance. M.D., C.M. psychiatry, internal medicine (Québec) Hons. BSc in pharmacology I have chronic pain and I have taken Duragesic and just about everything else. Answered by Clementine Abasta 1 year ago.

25 Mcg Fentanyl Patch Answered by Tracey Rysz 1 year ago.

Fentanyl Patch 25 Mcg Answered by Janine Mccant 1 year ago.

Fall asleep I guess. You can get a script at 30mg so it probably wouldn't kill you. How stupid though. I have gotten it for a bad back before and it just makes you feel stupid and sleepy. Don't understand what is supposed to be so great about it. Answered by Jarvis Rviz 1 year ago.


Anyone know anything about fentanyl patches (100mg) and overdose effects?
Asked by Brett Foerster 1 year ago.

first let me direct you to a great website www.rxlist.com. Personaly i am a nurse and have used these patches on a lot of patients and they are fantastic for chronic pain with little side effects. the only ones i have noted is skin irritation, headache and nausea. The following adverse effects have been reported in less than 1% of the 510 adult post-operative and cancer patients studied: Cardiovascular: bradycardia Digestive: abdominal distention Nervous: aphasia, hypertonia, vertigo, stupor, hypotonia, depersonalization, hostility Respiratory: stertorous breathing, asthma, respiratory disorder Skin and Appendages, General: exfoliative dermatitis, pustules Special Senses: amblyopia Urogenital: bladder pain, oliguria, urinary frequency FOR USE IN OPIOID-TOLERANT PATIENTS ONLY DURAGESIC® contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (DURAGESIC®) may be a particular target for abuse and diversion. DURAGESIC® is indicated for management of persistent moderate to severe chronic pain that: requires continuous, around-the-clock opioid administration for an extended period of time, and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids DURAGESIC® should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. Because serious or life-threatening hypoventilation could occur, DURAGESIC® (fentanyl transdermal system) is contraindicated: in patients who are not opioid-tolerant in the management of acute pain or in patients who require opioid analgesia for a short period of time in the management of post-operative pain, including use after out-patient or day surgeries (e.g., tonsillectomies) in the management of mild pain in the management of intermittent pain [e.g., use on an as needed basis (prn)] i hope this helps you a little, check our the website it has great info Answered by Onita Redpath 1 year ago.

Cardiac arrest IE u stop breathing and die.... Answered by Sabine Weinheimer 1 year ago.

constipation, RESPIRATORY DEPRESSION, itchiness, drowsiness, bradycardia, clammy skin....... get some narcan! Answered by Jami Throckmorton 1 year ago.


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