MedlinePlus Drug Information: Fentanyl Buccal (Transmucosal)

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Other drug names:	A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Fentanyl Buccal (Transmucosal)

(fen' ta nil)

Contents of this page:
Why is this medication prescribed? How should this medicine be used? Other uses for this medicine What special precautions should I follow? What special dietary instructions should I follow? What should I do if I forget a dose?	What side effects can this medication cause? What storage conditions are needed for this medicine? In case of emergency/overdose What other information should I know? Brand names

IMPORTANT WARNING: Return to top

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 United States); 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/cder) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using this medication.

Why is this medication prescribed? Return to top

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.

How should this medicine be used? Return to top

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.

To use fentanyl buccal lozenges, follow these steps:

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 nauseous 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 finished 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.

To use fentanyl buccal tablets, follow these steps:

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 nauseous 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.

Other uses for this medicine Return to top

This medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow? Return to top

Before using fentanyl buccal lozenges or tablets,

tell your doctor and pharmacist if you are allergic to fentanyl or any other medications.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following medications: antihistamines; buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol (Stadol); carbamazepine (Carbatrol, Epitol, Tegretol); medications for mental illness and nausea; muscle relaxants; other pain medications; nalbuphine (Nubain); naloxone (Narcan); nalmefene (Revex); pentazocine (Talwin); phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); sedatives; sleeping pills; and tranquilizers. Also tell your doctor or pharmacist if you are taking any of the following medications or if you have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor what herbal products you are taking, especially St. John's wort.
tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol or uses or has ever used street drugs or excessive amounts of prescription medications. Also tell your doctor if you have or have ever had a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; seizures; slowed heartbeat or other heart problems; low blood pressure; mental problems such as depression or hallucinations (seeing things or hearing voices that do not exist); lung disease such as asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema); or kidney or liver disease.
tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using fentanyl buccal lozenges or tablets, call your doctor. Do not breastfeed while using fentanyl buccal lozenges or tablets.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are using buccal fentanyl.
you should know that buccal fentanyl may make you drowsy or dizzy. Do not drive a car or operate machinery until you know how this medication affects you.
do not drink alcohol while you are using buccal fentanyl. Alcohol increases the chance that you will experience serious side effects of the medication.
you should know that buccal fentanyl may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using buccal fentanyl. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
if you have diabetes, you should know that each fentanyl buccal lozenge contains about 2 grams of sugar.
if you will be using the lozenges, talk to your dentist about the best way to care for your teeth during your treatment. The lozenges contain sugar and may cause tooth decay and other dental problems.
you should know that buccal fentanyl may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.

What special dietary instructions should I follow? Return to top

Avoid eating grapefruit and drinking grapefruit juice while using this medication.

What should I do if I forget a dose? Return to top

This medication is usually used as needed.

What side effects can this medication cause? Return to top

Buccal fentanyl may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

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

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

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/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine? Return to top

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 emergency/overdose Return to top

In case of overdose, remove the lozenge or tablet from the victim's mouth and call local emergency services at 911.

Symptoms of overdose may include:

drowsiness
dizziness
confusion
slow, shallow breathing or stopped breathing

What other information should I know? Return to top

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.

Brand names Return to top

Actiq®

Fentora®

Last Revised - 01/01/2008
Last Reviewed - 09/01/2008

American Society of Health-System Pharmacists, Inc. Disclaimer

AHFS^® Consumer Medication Information. © Copyright, 2009. 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.