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fentanyl

Generic Name: fentanyl (buccal) (FEN ta nil (BUK al))
Brand names: Fentora, Onsolis, ...show all 11 brand names.

What is fentanyl buccal?

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.

What is the most important information I should know about fentanyl buccal?

Do not use fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

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.

What should I discuss with my healthcare provider before using fentanyl buccal?

Do not use fentanyl unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant. 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. Serious, life-threatening side effects can occur if you take fentanyl before the MAO inhibitor has cleared from your body.

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;
liver disease;
kidney disease; or
a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether fentanyl buccal is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. Do not use fentanyl buccal without telling your doctor if you are breast-feeding a baby. 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.

How should I use fentanyl buccal?

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.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine or if anyone else has accidentally swallowed it. A fentanyl overdose can be fatal. Overdose symptoms may include slow breathing, extreme weakness or dizziness, pinpoint pupils, cold and clammy skin, or fainting.

What should I avoid while using fentanyl buccal?

Fentanyl can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase drowsiness or breathing problems caused by fentanyl.

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.

Fentanyl buccal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using fentanyl buccal and call your doctor at once if you have any of these serious side effects:

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;
swelling; or
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.

Fentanyl Dosing Information

Usual Adult Dose for Anesthesia:

Premedication for Anesthesia:
50 to 100 mcg IM, 30 to 60 minutes prior to surgery.
Lozenge: 5 mcg/kg (400 mcg is the maximum dose).
Lower doses should be used for vulnerable patients.

General Anesthesia:
Total Low dose: 2 mcg/kg (minor procedures).
Maintenance low dose: Infrequently needed.
Total Moderate dose: 2 to 20 mcg/kg.
Maintenance moderate dose: 25 to 100 mcg IV/IM.
Total high dose: 20 to 50 mcg/kg (prolonged surgeries).
Maintenance high dose: 25 mcg to half of the initial dose.

Adjunct to Regional Anesthesia:
50 to 100 mcg IM or slow IV over 3 to 5 minutes as required.

Postoperative :
50 to 100 mcg IM. May repeat dose in 1 to 2 hours as needed.

Usual Adult Dose for Pain:

Transdermal patch - Initial dose: 25 mcg/hour patch (unless opioid tolerance) every 72 hours.

Transmucosal - Initial dose: 200 mcg, place in mouth (in-between cheek and lower gum) and suck over 15 minutes (do not chew or swallow).

Fentanyl iontophoretic transdermal system - Patients should be titrated to comfort before initiating the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system should be applied to intact, non-irritated, non-irradiated skin on the chest or upper outer arm.

Patients must have access to supplemental analgesia during treatment with the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system provides a 40 mcg dose of fentanyl per activation on-demand. It is important to instruct patients how to operate fentanyl iontophoretic transdermal system to self-administer doses of fentanyl as needed to manage their acute, short-term, postoperative pain. Only the patient should administer doses from fentanyl iontophoretic transdermal system. Each on-demand dose is delivered over a 10-minute period. To initiate administration of a fentanyl dose, the patient must press the button firmly twice within 3 seconds. An audible tone (beep) indicates the start of delivery of each dose; the red light remains on throughout the 10 minute dosing period.

Patients on chronic opioid therapy or with a history of opioid abuse may require higher analgesic doses in the postoperative period than are available from fentanyl iontophoretic transdermal system. Therefore, these patients should be evaluated frequently to ensure they are receiving adequate analgesia.

A maximum of six 40 mcg doses per hour can be administered by fentanyl iontophoretic transdermal system. The maximum amount of fentanyl that can be administered from a single fentanyl iontophoretic transdermal system over 24 hours is 3.2 mg (eighty 40 mcg doses). Each fentanyl iontophoretic transdermal system operates for 24 hours or until eighty doses have been administered, whichever occurs first. Up to three consecutive fentanyl iontophoretic transdermal systems may be used sequentially, each applied to a different skin site for a maximum of 72 hours of therapy for acute, short-term, postoperative pain.

Buccal Tablet
Initial Dose: 100 mcg.
Dose Titration: Patients should be titrated to a dose of fentanyl buccal tablet that provides adequate analgesia with tolerable side effects.

For patients switching from oral transmucosal fentanyl citrate to fentanyl buccal tablet, the starting dose of fentanyl buccal tablet should be as follows. An oral transmucosal fentanyl citrate dose of 200 mcg or 400 mcg converts to an initial fentanyl buccal tablet dose of 100 mcg. An oral transmucosal fentanyl citrate dose of 600 or 800 mcg converts to an initial fentanyl buccal tablet dose of 200 mcg. And, an oral transmucosal fentanyl citrate dose of 1200 mcg or 1600 mcg converts to an initial fentanyl buccal tablet dose of 400 mcg.

Re-dosing Patients Within a Single Episode: Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one fentanyl buccal tablet dose. Re-dosing may occur 30 minutes after the start of administration of fentanyl buccal tablet and the same dosage strength should be used.

Usual Pediatric Dose for Anesthesia:

1 to 12 years:
Induction and Maintenance of Anesthesia:
IM,IV: 2 to 3 mcg/kg.
Continuous epidural: 1 mcg/kg/hour.
Low dose: 5 mcg/kg lozenge.
Moderate dose: 10 mcg/kg lozenge
High dose: 15 mcg/kg lozenge
Maximum dose: 400 mcg
Lozenge should be sucked 20 to 40 minutes prior to desired effect.

Usual Pediatric Dose for Sedation:

Study (n=23)
Mechanical Ventilation (greater than or equal to 7 days and less than 3 months) : 3 mcg/kg/hr IV, slowly increase dose to desired effect.

Study (n=133)
Conscious sedation (greater than or equal to 2 years): <= 2 mcg/kg IV initially, then slowly titrate upwards if needed (Maximum total dose in 1 hour: 5 mcg/kg)

Usual Pediatric Dose for Pain:

Review Oncology Patients (n=58)
Continuous Epidural: 1 mcg/kg/hour

What other drugs will affect fentanyl buccal?

Cold or allergy medicine, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by fentanyl buccal. Tell your doctor if you regularly use any of these medicines, or any other narcotic pain medicine.

Before using this medication, tell your doctor if you are using any of the following drugs:

aprepitant (Emend);
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.

Where can I get more information?

Your pharmacist can provide more information about fentanyl buccal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.