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Generic Name: fentanyl buccal

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Onsolis, Fentora
A narcotic analgesic - It is used to treat breakthrough cancer pain that your long acting pain medic... more
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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 buccal
(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 breakthrough cancer pain that your long acting pain medicine does not control. Do not use this medicine for a pain that will go away in a few days like pain from surgery, doctor or dentist visits. The medicine is used only by people who have been taking an opioid or narcotic pain medicine for at least a 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
  • dry mouth
  • feeling faint, lightheaded
  • hallucination
  • irregular heartbeat
  • mouth pain, sores
  • 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):

  • dizzy
  • headache
  • loss of appetite
  • nausea, vomiting
  • sweating
  • tingling in mouth

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
Take this medicine by mouth. Follow the directions on the prescription label. Do not remove a tablet from the blister until you are ready to use it. Peel the blister backing away to expose the tablet. Do not push the tablet through the blister. Place the tablet in your mouth between your cheek and gum and leave in place until the tablet is dissolved. After 30 minutes if there is any tablet left, swallow it with a glass of water. Do not take your medicine more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 16 years for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
This medicine is only used when needed for pain.

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What may interact with this medicine?

  • alcohol
  • antihistamines
  • barbiturates, like phenobarbital
  • clarithromycin, erythromycin
  • general anesthetics
  • grapefruit juice
  • itraconazole, ketoconazole
  • MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for HIV
  • medicines for pain
  • medicines for sleep
  • muscle relaxants
  • naltrexone
  • phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
  • verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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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?
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. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

If you develop problems breathing or slow breathing, remove this medicine from your mouth, and call emergency for help.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

This 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.

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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
  • breathing problems
  • drug abuse or addiction
  • head injury
  • if you frequently drink alcohol containing drinks
  • kidney disease
  • liver disease
  • taken an MAOI like Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
  • an unusual or allergic reaction to fentanyl, other opioid analgesics, 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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