Generic Name: fentanyl (buccal) (FEN ta nil (BUK al))Brand Names: Fentora, Onsolis
Fentanyl is a narcotic (opioid) pain medicine.
Fentanyl buccal tablets are used to treat "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.
Fentanyl buccal may also be used for other purposes not listed in this medication guide.
Fentanyl buccal tablets are used to treat "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for treating pain that is not cancer-related, such as general headaches or back pain.Do not use fentanyl if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.
Before using fentanyl buccal, tell your doctor if you have a breathing disorder, a head injury or brain tumor, seizures, mental illness, a heart rhythm disorder, low blood pressure, liver or kidney disease, or a history of drug or alcohol addiction.Keep this medicine out of the reach of children or pets. The amount of fentanyl in each fentanyl buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens. Fentanyl buccal may be habit-forming and should be used only by the person it was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use fentanyl buccal:
a breathing disorder such as chronic obstructive pulmonary disease (COPD);
a history of head injury or brain tumor;
a heart rhythm disorder;
seizures or epilepsy;
mental illness such as depression, hallucinations;
low blood pressure;
kidney disease; or
a history of drug or alcohol addiction.
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts or use it for longer than recommended by your doctor. Using too much fentanyl can be very harmful or fatal. Follow the directions on your prescription label.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.If you switch from using Actiq (fentanyl oral transmucosal devices) to using Fentora (fentanyl buccal tablets), you will not use the same fentanyl dose. Fentora is given at lower doses than Actiq. If you use the same dose of each medication, you may have life-threatening overdose symptoms.
To use fentanyl buccal tablets (Fentora):
Keep the tablet in its blister pack until you are ready to take the medicine. Separate a single blister from the rest of the pack by tearing along the dotted lines. Bend the blister unit on the fold line and peel the foil backing off. Do not push a tablet through the foil or you may damage the tablet.
Tip the blister unit and drop the tablet into the palm of your hand. Using dry fingers, place the tablet between your upper gum and your cheek, near your back teeth. The tablet will begin to dissolve right away. You may feel a slight bubbling while the tablet dissolves.
Do not break, chew, or swallow the tablet whole. Allow it to dissolve in your mouth without chewing. This should take about 14 to 25 minutes.
If any pieces of the tablet remain in your mouth after 30 minutes, drink a glass of water to wash them down.
You may use a second tablet 30 minutes after the first. Use only the same strength and amount you used for the first dose. Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine.If you feel dizzy, nauseated, or very sleepy while the tablet is still in your mouth, spit the medicine out into a sink or toilet and rinse your mouth with water to remove all remaining pieces of the tablet. Call your doctor for instructions. Call your doctor if your pain does not improve, or if it gets worse after using this medication.
You may have withdrawal symptoms when you stop using fentanyl after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.Store this medication at room temperature, away from heat and moisture. Do not allow the tablets to freeze. Keep this medicine out of the reach of children or pets. The amount of fentanyl in each fentanyl buccal tablet can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.
Keep track of how many tablets have been used from each new package of this medicine. Fentanyl is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.
If you end up not using a tablet that has been removed from the blister pack, flush the tablet down a toilet. Do not use a fentanyl buccal tablet that has been left out of the blister pack for more than a few minutes.
Throw away any other unused tablets by removing them from the blister pack and flushing them down a toilet.
Since fentanyl buccal tablets are taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
weak, shallow breathing;
severe weakness, drowsiness, or confusion;
cold, clammy skin; or
feeling light-headed or fainting.
Less serious side effects may include:
nausea, vomiting, stomach pain, constipation;
dizziness, drowsiness, headache;
pain or mouth sores where the tablet was placed.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before using this medication, tell your doctor if you are using any of the following drugs:
diltiazem (Cardizem, Cartia, Dilacor, Tiazac);
verapamil (Calan, Covera, Isoptin, Verelan);
an antibiotic such as clarithromycin (Biaxin) or erythromycin (E-Mycin Ery-Tab, E.E.S.);
antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral); or
HIV medicines such as fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept).
This list is not complete and there may be other drugs that can interact with fentanyl buccal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.