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Drug Notebook

Generic Name: fentanyl transdermal patch

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Duragesic, Duragesic-12, Duragesic-50, Duragesic-75, Duragesic-100, Duragesic-25
A narcotic analgesic - It is used to treat persistent, moderate to severe chronic pain
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FDA Alerts

Special Alerts:

[Posted 12/21/2007] FDA issued an update that highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system (patch). FDA previously issued a Public Health Advisory and Information for Healthcare Professionals in July 2005 regarding the appropriate and safe use of the transdermal system. However, the Agency continues to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naive patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant.

Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. Directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentanyl , http://www.fda.gov/cder/drug/advisory/fentanyl_2007.htm and http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_2007HCP.htm.

[UPDATED 09/26/2007] FDA issued a Public Health Advisory and a Healthcare Professional Sheet to alert healthcare professionals and consumers regarding concerns over the use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events. The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.

FDA warned physicians and other healthcare professionals that it is critical to follow product labeling when administering Fentora. FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. It is critical that Fentora not be used in patients who are not opioid tolerant.

Patients also must be under a doctor’s care and close supervision while taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately.

In addition, FDA is concerned about the improper substitution of Fentora, a quick acting pain drug, for other pain medicines. Fentora is not the same as other fentanyl products and cannot be substituted for Actiq, another fentanyl product used to treat breakthrough cancer pain. Because Fentora delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora, http://www.fda.gov/cder/drug/advisory/fentalyn_buccal.htm and http://www.fda.gov/cder/drug/InfoSheets/HCP/fentanyl_buccal.htm

[Posted 09/13/2007] Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding fentanyl buccal tablet (Fentora). Fentanyl buccal tablet is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with fentanyl buccal tablet. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of fentanyl buccal tablet to reduce the risk of respiratory depression. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora, http://www.fda.gov/medwatch/safety/2007/fentora_deardoc_%20Letter_09-10-07.pdf, http://www.fda.gov/medwatch/safety/2007/Fentora_DearHCP_Letter%2009-10-07.pdf and http://www.fda.gov/medwatch/safety/2007/fentora_PI_9-12-07.pdf.

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fentanyl transdermal patch
(FEN ta nil)
What is this medicine?What is the price of this medication and similar alternatives?What side effects may I notice from receiving this medicine?How should I use this medicine?What if I miss a dose?What may interact with this medicine?Who should NOT use this medication?What should I watch for while using this medicine?What should I tell my health care provider before I take this medicine?Can I stop taking the medication if I feel better?I am on so many medications; do I have to take them all?Where can I get more information?

What is this medicine?
FENTANYL (FEN ta nil) is a pain reliever. It is used to treat persistent, moderate to severe chronic pain. It is used only by people who have been taking an opioid or narcotic pain medicine for more than one week.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Actiq 1200MCG Lollipop CEPHALON10/$708.23 or 30/$2069.71
Actiq 1600MCG Lollipop CEPHALON20/$1973.95 or 30/$2960.92
Actiq 200MCG Lollipop CEPHALON20/$696.07 or 30/$1044.1
Actiq 400MCG Lollipop CEPHALON20/$888.28 or 30/$1332.42
Actiq 600MCG Lollipop CEPHALON20/$1076.77 or 30/$1615.15
Actiq 800MCG Lollipop CEPHALON20/$1255.99 or 30/$1883.98
Duragesic-100 100MCG/HR Patches JANSSEN20/$1646.31 or 30/$2469.47
Duragesic-12 12MCG/HR Patches JANSSEN20/$378.64 or 30/$567.96
Duragesic-25 25MCG/HR Patches JANSSEN20/$457.64 or 30/$686.46
Duragesic-50 50MCG/HR Patches JANSSEN20/$823.09 or 30/$1234.64
Duragesic-75 75MCG/HR Patches JANSSEN20/$1275.76 or 30/$1913.64
Fentanyl 100MCG/HR Patches SANDOZ20/$839.99 or 30/$1259.98
Fentanyl 12 12.5)MCG/HR Patches (MYLAN5/$67.99 or 10/$135.99
Fentanyl 50MCG/HR Patches SANDOZ20/$526.62 or 30/$789.94
Fentanyl 75MCG/HR Patches SANDOZ20/$633.31 or 30/$949.97
FentaNYL Citrate 1200MCG Lollipop BARR LABS10/$299.95 or 30/$799.93
FentaNYL Citrate 1600MCG Lollipop TEVA PHARMACEUTICALS USA20/$599.95 or 30/$831.58
FentaNYL Citrate 400MCG Lollipop WATSON LABS20/$399.95 or 30/$599.93
Fentora 200MCG Tablets CEPHALON20/$412.65 or 30/$618.97

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • changes in vision
  • confusion
  • feeling faint, lightheaded
  • fever, flu-like symptoms
  • hallucination
  • high or low blood pressure
  • irregular heartbeat
  • problems with balance, talking, walking
  • trouble passing urine or change in the amount of urine
  • unusual bleeding or bruising
  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • constipation
  • dry mouth
  • itching where the patch was applied
  • loss of appetite
  • nausea, vomiting
  • sweating

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How should I use this medicine?
Apply the patch to your skin. Do not cut or damage the patch. A cut or damaged patch can be very dangerous because you may get too much medicine. Select a clean, dry area of skin above your waist on your front or back. The upper back is a good spot to put the patch on children or people who are confused because it will be hard for them to remove the patch. Do not apply the patch to oily, broken, burned, cut, or irritated skin. Use only water to clean the area. Do not use soap or alcohol to clean the skin because this can increase the effects of the medicine. If the area is hairy, clip the hair with scissors, but do not shave.

Take the patch out of its wrapper, and take off the protective strip over the sticky part. Do not use a patch if the packaging or backing is damaged. Do not touch the sticky part with your fingers. Press the sticky surface to the skin using the palm of your hand. Press the patch to the skin for 30 seconds. Wash your hands at once.

Take off the old patch before putting on a new patch. Apply each new patch to a different area of skin. If a patch comes off or causes irritation, remove it and apply a new patch to different site. To get rid of used patches, fold the patch in half with the sticky sides together. Then, flush it down the toilet. Replace the patch every 3 days or as directed by your doctor or health care professional. Follow the directions on the prescription label. Do not take more medicine than you are told to take.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

If someone accidentally uses a fentanyl patch and is not awake and alert, immediately call 911 for help. If the person is awake and alert, call a doctor, health care professional, or the Poison Control Center.

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What if I miss a dose?
If you forget to replace your patch, take off the old patch and put on a new patch as soon as you can. Do not apply an extra patch to your skin. Do not wear more than one patch at the same time unless told to do so by your doctor or health care professional.

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What may interact with this medicine?

  • alcohol or medicines that contain alcohol
  • antihistamines
  • clarithromycin
  • diltiazem
  • erythromycin
  • herbal products that contain St. John's wort
  • itraconazole
  • ketoconazole
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for pain like pentazocine, buprenorphine, butorphanol, nalbuphine, tramadol, and propoxyphene
  • medicines for sleep
  • muscle relaxants
  • naltrexone
  • nelfinavir
  • nicardipine
  • phenobarbital, phenytoin, or fosphenytoin
  • rifampin
  • ritonavir
  • troleandomycin
  • verapamil

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Who should NOT use this medication?

  • Patients receiving MAO inhibitors.
  • Known hypersensitivity to fentanyl or any ingredient or component (e.g., the adhesive in transdermal systems) of the respective formulation.
  • Intrabuccal (transmucosal) preparations contraindicated in the management of acute pain (e.g., painful injuries, migraine or other headaches) or postoperative pain and in non-opiate-tolerant patients because of the risk of life-threatening respiratory depression. (See Buccal [Transmucosal] Tablets and Lozenges in Boxed Warning.)
  • Transdermal preparations contraindicated in acute or postoperative pain, in chronic pain that is mild or intermittent and manageable with less potent analgesics, and in patients not already receiving and tolerant of opiates because of the prolonged duration of effects and risk of serious or life-threatening respiratory depression. (See Transdermal Systems in Boxed Warning.)
  • Transdermal preparations also contraindicated in patients with substantial respiratory depression, especially in settings where equipment for monitoring and resuscitation is not available; in patients with acute or severe bronchial asthma; and in those with known or suspected paralytic ileus.

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What should I watch for while using this medicine?
Other pain medicine may be needed the first day you use the patch because the patch can take some time to start working. Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medicine. Tolerance means that you will need a higher dose of the medicine for pain relief. Tolerance is normal and is expected if you take the medicine for a long time.

Do not suddenly stop taking your medicine because you may develop a severe reaction. Your body becomes used to the medicine. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy when you first start taking the medicine or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medicine affects you. Stand or sit up slowly.

The medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

Your mouth may get dry. Drinking water, chewing sugarless gum, or sucking on hard candy may help. See your dentist every 6 months.

Heat can increase the amount of medicine released from the patch. Do not get the patch hot by using heating pads, heated water beds, electric blankets, and heat lamps. You can bathe or swim while using the patch. But, do not use a sauna or hot tub. Tell you doctor or health care professional if you get a fever.

If gel leaks from the patch, wash your skin well with water only. Do not use soap or cleansers containing alcohol. Remove the patch from your skin and throw away as instructed above. A used patch still contains enough medicine to cause serious side effects and even death to children or pets.

If you are going to have a magnetic resonance imaging (MRI) procedure, tell your MRI technician if you have this patch on your body. It must be removed before a MRI.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • brain tumor
  • Crohn's disease, inflammatory bowel disease, or ulcerative colitis
  • drug abuse or addiction
  • head injury
  • heart disease
  • if you frequently drink alcohol containing drinks
  • kidney disease or problems going to the bathroom
  • liver disease
  • lung disease, asthma, or breathing problems
  • mental problems
  • skin problems
  • taken isocarboxazid, phenelzine, tranylcypromine, or selegiline in the past 2 weeks
  • an allergic or unusual reaction to fentanyl, meperidine, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
If you are taking an analgesic for pain and you are no longer experiencing the pain you may stop using the medication. In general, pain medications are to be used on an ?as needed? basis.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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