Buccal fentanyl should be used only to treat breakthrough cancer pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. This medication should not be used to treat pain other than chronic cancer pain, especially short-term pain such as pain from an injury or pain after a medical or dental procedure. Buccal fentanyl should only be prescribed by doctors who are experienced in treating pain in cancer patients. Buccal fentanyl may cause serious breathing problems or death if it is used by people who are not being treated with other narcotic medications or who are not tolerant to narcotic medications.
Buccal fentanyl comes as two different products, a lozenge and a tablet. The medication in fentanyl lozenges is absorbed differently by the body than the medication in fentanyl buccal tablets, so one product cannot be substituted for the other. If you are switching from one product to the other, your doctor will prescribe a dose that is best for you.
Buccal fentanyl may cause serious harm or death if taken accidentally by a child or by an adult who has not been prescribed the medication. Even partially used fentanyl buccal lozenges and tablets may contain enough medication to cause serious harm or death to children or other adults. Always keep fentanyl buccal lozenges and tablets in a locked storage space that is out of the reach of children. The manufacturer of the lozenges supplies child resistant locks and other items to help you store your medication safely. Ask your doctor how you can obtain these items. Dispose of partially used buccal lozenges or tablets according to the manufacturer's directions immediately after you remove them from your mouth.
Tell your doctor if you are taking any of the following medications: certain antibiotics such as clarithromycin (Biaxin), erythromycin (Erythocin), and troleandomycin (TAO) (not available in the US); certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); aprepitant (Emend); certain medications for human immunodeficiency virus (HIV) such as amprenavir (Agenerase), fosamprenavir (Lexiva), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); nefazodone; or verapamil (Calan, Covera, Verelan). Taking these medications with fentanyl buccal lozenges or tablets may increase the risk that you will develop serious or life-threatening breathing problems. Your doctor may need to change the dosages of your medications and will monitor you carefully.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fentanyl and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using this medication.
Buccal fentanyl is used to treat breakthrough pain (sudden episodes of pain that occur despite round the clock treatment with pain medication) in cancer patients who are taking regularly scheduled doses of another narcotic (opiate) pain medication, and who are tolerant (used to the effects of the medication) to narcotic pain medications. Fentanyl is in a class of medications called narcotic (opiate) analgesics. It works by changing the way the brain and nervous system respond to pain.
Buccal fentanyl comes as a lozenge on a handle (Actiq) and a tablet (Fentora) to dissolve in the mouth. Fentanyl buccal lozenges and tablets are used as needed to treat breakthrough pain, but not more often than four times a day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand.
Your doctor will probably start you on a low dose of fentanyl buccal lozenges or tablets and gradually increase your dose until you find the dose that will relieve your breakthrough pain. When you start using buccal fentanyl and are still trying to reach the correct dose, if you still have pain after using one buccal lozenge or tablet, your doctor may tell you to use a second lozenge or tablet. You may use the second lozenge 15 minutes after you finish the first lozenge, or use the second tablet 30 minutes after you started using the first tablet. Do not use a second lozenge or tablet to treat the same episode of pain unless your doctor tells you that you should. Talk to your doctor about how well the medication is working and whether you are experiencing any side effects so that your doctor can decide whether your dose should be adjusted.
Do not use fentanyl buccal lozenges or tablets more than four times a day. Call your doctor if you experience more than four episodes of breakthrough pain per day. Your doctor may need to adjust the dose of your other pain medication to better control your pain.
Fentanyl buccal lozenges and tablets should be used along with your other pain medication(s). Do not stop taking your other pain medication(s) when you begin your treatment with fentanyl buccal lozenges or tablets.
Buccal fentanyl may be habit-forming. Do not use a larger dose of buccal fentanyl, use the medication more often, or use it for a longer period of time than prescribed by your doctor. Do not stop using fentanyl buccal lozenges or tablets without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop using fentanyl buccal lozenges or tablets, you may experience unpleasant withdrawal symptoms.
Check the blister package and the handle of the lozenge to make sure the lozenge contains the dose of medication you have been prescribed.
Use scissors to cut open the blister package, and remove the lozenge. Do not open the blister package until you are ready to use the medication.
Place the lozenge in your mouth, between your cheek and gum. Actively suck on the lozenge, but do not chew or bite it. Move the lozenge around in your mouth, from one side to the other, using the handle. Twirl the handle often.
Do not eat or drink anything while the lozenge is in your mouth.
Finish the lozenge in about 15 minutes.
If you begin to feel dizzy, very sleepy, or nauseated before you have finished the lozenge, remove it from your mouth. Dispose of it immediately as described below or put it in the temporary storage bottle for later disposal.
If you finish the entire lozenge, throw the handle away in a garbage can that is out of the reach of children. If you did not finish the entire lozenge, hold the handle under hot running water to dissolve all the medication, and then throw the handle away in a garbage can that is out of the reach of children and pets.
Separate one blister unit from the blister card by tearing along the perforations. Peel back the foil to open the blister unit. Do not try to push the tablet through the foil. Do not open the blister unit until you are ready to use the tablet.
Place the tablet in your mouth between one of your upper back teeth and your gum.
Leave the tablet in place until it dissolves completely. You may notice a gentle bubbling feeling between your cheek and gum as the tablet dissolves. It may take 14 to 25 minutes for the tablet to dissolve. Do not split, chew, bite, or suck the tablet.
If any of the tablet is left in your mouth after 30 minutes, swallow it with a drink of water.
If you begin to feel dizzy, very sleepy, or nauseated before the tablet dissolves, rinse your mouth with water and spit the remaining pieces of tablet into the sink or toilet. Flush the toilet or rinse the sink to wash away the tablet pieces.
This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.
Avoid eating grapefruit and drinking grapefruit juice while using this medication.
This medication is usually used as needed.
drowsiness
nausea
stomach pain
vomiting
constipation
diarrhea
gas
heartburn
loss of appetite
weight loss
difficulty urinating
weakness
headache
changes in vision
anxiety
depression
hallucinations (seeing things or hearing voices that do not exist)
unusual thinking
unusual dreams
difficulty falling asleep or staying asleep
dry mouth
sweating
flushing
uncontrollable shaking of a part of the body
back pain
chest pain
pain, sores, or irritation in the mouth in the area where you placed the buccal tablet
rash
itching
swelling of the hands, arms, feet, ankles, or lower legs
slow, shallow breathing
extreme drowsiness
dizziness
confusion
fainting
heartbeat that is slower or faster than normal
seizures
Buccal fentanyl may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the blister package it came in, tightly closed, and out of reach of children. Store fentanyl buccal lozenges and tablets in a safe place so that no one else can take them accidentally or on purpose. Use the child-resistant locks and other supplies provided by the manufacturer to keep children away from the lozenges. Keep track of how many lozenges or tablets are left so you will know if any are missing. Store fentanyl buccal lozenges and tablets at room temperature and away from excess heat and moisture (not in the bathroom).
You must immediately dispose of any medication that is outdated or no longer needed. Dispose of unneeded lozenges by removing each lozenge from the blister package, holding the lozenge over the toilet, and cutting off the medicine end with wire cutters so that it falls into the toilet. Throw away the remaining handles in a place that is out of the reach of children and pets, and flush the toilet twice when it contains up to five lozenges. Dispose of unneeded buccal tablets by removing the tablets from the blister package and flushing them down the toilet. Call your pharmacist or the manufacturer if you have questions or need help disposing of unneeded medication.
In case of overdose, remove the lozenge or tablet from the victim's mouth and call local emergency services at 911.
drowsiness
dizziness
confusion
slow, shallow breathing or stopped breathing
Keep all appointments with your doctor.
Do not let anyone else use your medication, even if he or she has the same symptoms that you have. Selling or giving away this medication may cause severe harm or death to others and is against the law.
This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Reviewed - 04/01/2012
AHFS® Consumer Medication Information. © Copyright, 2012. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.