Application Information

This drug has been submitted to the FDA under the reference 019813/001.

Names and composition

"DURAGESIC-100" is the commercial name of a drug composed of FENTANYL.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
019813/001 DURAGESIC-100 FENTANYL FILM, EXTENDED RELEASE/TRANSDERMAL 100MCG 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

Duragesic 100 mcg/h information on side-effects?
Asked by Leanne Prible 1 year ago.

possible side effects. breathing; swelling of your face, lips, tongue, or throat. Stop using Duragesic and call your doctor at once if you have any of these serious side effects: weak, shallow breathing; severe weakness, feeling light-headed or fainting; cold, clammy skin; or pale skin, easy bruising or bleeding. Continue using Duragesic and talk with your doctor if you have any of these less serious side effects: nausea, vomiting, stomach pain, constipation, gas; dizziness, drowsiness, anxiety, sleep problems (insomnia); muscle stiffness, back pain; itching, blistering, redness, or swelling where the patch or device was worn; or increased sweating, urinating less than usual. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. Answered by Rodolfo Lahne 1 year ago.

COMMON Dermatologic: Pruritus, Sweating symptom Gastrointestinal: Constipation, Nausea, Vomiting, Xerostomia Neurologic: Asthenia, Confusion, Dizziness, Sedated Renal: Urinary retention SERIOUS Cardiovascular: Cardiac dysrhythmia (1-3%), Chest pain (1-3%), Hypertension, Hypotension Respiratory: Apnea (3-10%), Hypoventilation, Respiratory depression Answered by Glennie Zaza 1 year ago.

Nausea, vomiting, constipation, confusion, drowsiness, dizziness, dry mouth, sweating, mild itching/redness on the application site, or weakness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type and stool softener). Remember that your doctor has prescribed this medication because the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular/shallow breathing, fainting, mental/mood changes, uncontrolled muscle movements (tremors), change in the amount of urine, chest pain, fast/pounding heartbeat. Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, slow/irregular heartbeat, seizures, vision changes. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist. Answered by Grayce Stample 1 year ago.

Honestly? ^_^ It's just a little bit bizarre: --In commonplace, persons get extra centered while I'm round. I've obvious this peculiarly in my condominium constructing, while I linger within the normal places, the persons which can be there--a few of whom are mentally in poor health, others aged--end up extra centered and considerate. And it sort of feels like I *can not* cross browsing and not using a bunch of individuals coming in *after me*.....my presence turns out to suck buyers in. --More mainly, one on one, men generally tend to get just a little angry or intimidated. It's unhappy, plenty of my identical-intercourse peers believe a have to get into steady, aggressive "pissing contests" to peer who is smarter or who has the wittier comeback. It's bizarre too. I do not *appear* like a jock or some thing, so I do not get in which the alpha-male smell they choose up is coming from. --And extra mainly with ladies....it relies. If they are already adverse toward men like me (older, somewhat overweight), they'll be extra so. But if now not.... Once I begin speakme, they begin guffawing. ^_^ I appear undeniable in truly existence, however persons are stunned while I *speak* they usually listen the voice that comes out. I bet I appear as a substitute dumb or whatever. I've honestly stuck ladies doing the a hundred and eighty and begin *smiling at me* after they listen me speak. It's ordinary. I bet my phrases *are* prettier than I am. ^_^ So the outcome is both disconcerting or seductive, relying on how open the females are to it. Hope this is helping. ^_^ Answered by Charleen Richberg 1 year ago.

Go with what mew says, he must be in the medical field. He has answered a couple of my questions. Answered by Kimi Onyeagu 1 year ago.

mcg/h ???? are you talking about an infusion? Answered by Marget Purifoy 1 year ago.


My dr. is taking me off duragesic 100 and giving me a pill everyday that is basically the same.what is it?
Asked by Ben Oveson 1 year ago.

Impossible to say...there are many alternatives. Answered by Kris Wilk 1 year ago.


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 Maryanna Letendre 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, fentanyl, fentanyl topical, Fentora, Frova, frovatriptan, furazolidone, Furoxone, GenRx Tramadol, GHB, Hold DM, hypericum perforatum, imipramine, imipramine pamoate, Imitrex, Imitrex Nasal, Imitrex Statdose, Imitrex Statdose Refill, iohexol, Ionamin, Ionsys, iopamidol, Iopamidol-370, isocarboxazid, Isovue-128, Isovue-200, Isovue-250, Isovue-300, Isovue-370, Isovue-M-200, Isovue-M-300, Jack & Jill Thin Strips Cough, Jumex, l-tryptophan, Larapam SR, levomethadyl acetate, linezolid, lisdexamfetamine, lithium, lithium carbonate, lithium carbonate extended release, lithium citrate, Lithobid, Lithonate, Lithotabs, Lloydspharmacy Dry Adult Cough, ma huang, Marplan, Matulane, Maxalt, Maxalt-MLT, Mazanor, mazindol, Mega-Trim, Melfiat, Mellaril, Mellaril-S, meperidine, Meridia, methamphetamine, methamphetamine extended release, metrizamide, Migranal, milnacipran, mirtazapine, Myelo-Kit, naratriptan, Nardil, nefazodone, Neocitran Thin Strips Cough, Norpramin, nortriptyline, Novahistine DM, 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 Louis Hewell 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 Leonor Brookins 1 year ago.

Tramahexal Sr 100 Answered by Elissa Dragg 1 year ago.


Does anyone have any suggestions to help migraines?
Ok, I have been on Midrin, Imitrex, Naproxen, Motrin, Excedrin Migraine, and once had a shot of toradol, all of which has had very little effect. Asked by Tonisha Aldana 1 year ago.

One of the problems with all migraine medications is that you build up a tolerance (even to over the counter meds). Take them long enough, and your body will get used to the meds, and the pain may not go away. That could be why your meds are only working for 6 months. I have been off work for 2 years because of migraines and a migraine related stroke, but have suffered migraines since I was a child. I have tried every medication imaginable, and up until November '05 was on a Duragesic 100 patch (this medication was 80x more powerful than morphine, and in the end still was not doing the trick). I have been in the ER still suffering after receiving over 300cc's of Demerol, and thought nothing would ever help. I went to a new Neurologist who told me to get off of the analgesics, be it Tylenol, Ibuprofen, or Rx drugs. He also took me off of Ametriptaline and Serataline. It was hell when I did get a migraine, as I couldn't take anything, and had to "suffer through the pain", but I have been headache free for the past month. I know that doesn't seem long, but I can't remember the last time I've gone this long without pain. Answered by Patience Hord 1 year ago.

I had migraines as a toddler from what my parents say. Migraines are not your typical headache. People often confuse a bad headache for a migraine. Migraines are a disease. I don't like hospitals. I'm not fond of drugs. I take Midrin (available by rx only). Did you try Imitrex? Ok, I stopped smoking, eating chocolate, meat, some dairy. These are someone known cause for migraines. Or its just in the genes. Drink plenty of water and get a full 8 hours sleep every night if possible. Take short walks get some air. If you get naucious, try sucking on a piece of fireball candy. All this helped me. Hope it does the same for you. Answered by Le Yankee 1 year ago.

Your migraines could be a sign of something really serious (besides stress and anxiety). Try drinking black tea and yoga. It relaxes your mind, body, and soul. I would also suggest seeing your Primary Health Care Provider if your migraines get worse. I was diagnosed with severe migraines years ago and placed on medication (basically a high dose of Excedrin). I stopped the pills, got rid of the people who brought negativity to my life, started exercising, and I haven't got a migraine since then. GOOD LUCK! Laugh more, stress less! Answered by Frank Muskthel 1 year ago.

Here's some things you can try: Try drinking a caffeinated soda. The caffeine should help. Eat a banana because of the potassium. Wear sunglasses outside and don't have really bright lightbulbs in the house because that can make the migraine worse. I'm guessing you've already tried Imitrex. That works for my mom. Make sure you are getting enough sleep on a comfortable pillow and bed. Try to resolve some stress issues that can be causing it. Sometimes just accomplishing one simple task can help. Good luck! Answered by Raymond Grazier 1 year ago.

My friend is on birth control called Yasmin. It steadies her hormones, therefor making her migraines less common. I would suggest that, otherwise ask your doctor about a blood pressure medicine. Also, try Midrin or Imitrex injections. Those are supposed to work phenominal. I get migraines and I use the generic form of Esgic Plus and it works great. Answered by Izola Pinault 1 year ago.

Do a website search on migraine triggers. I eliminated nutrasweet and my migraines shortened to one a month (menstrual migraine). Yogurt is also a big problem with me as well as apple juice. Birth control pills can also be the cause. Good luck - I feel for you and understand what you are going through. Answered by Alisha Combe 1 year ago.

Get an appointment with a chiropractor. If there are any mis-alignments in your neck bones (spine), it can cause your muscle to be tight and trigger headaches, including migraines. I think you will be amazed with the results. Let me know how it goes for ya. Answered by Woodrow Rusch 1 year ago.

I have been on Topamax for about a year now and it works very well. The only major side effect I have experienced has been some weight loss. That in combination with Imitrex when I get a migrane tends to work. Answered by Marlin Girbach 1 year ago.

have you tried herbal supplements ? They have been clinically proven to eliminate or reduce migraines. This site has excellent info about this. Good Luck ! Answered by China Mizenko 1 year ago.

yes absolutely!!! you have to eat omega 3 avry day, eat lot lot lot fish. in fish you have all what you need for migraines,eat blue fish from ocean they are so healty, trust me!!! stop eating meat, because you will get more migraines , if you eat meat , eat only white meat -like cicken-fish. trust me and avry day take pils omega 3, that is fish oil, you can buy this capsule omega 3 where you buy pils for all ( is defecaulte for me to explaine where to buy, because i am from Slovenia and some words i dont know to tell in english, hope you understend what i meen). well i wish you all best and happy life take care :) Answered by Anja Engbretson 1 year ago.


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