fentanyl buccal
Generic Name: fentanyl (buccal) (FEN ta nil (BUK al))
Brand Names: Fentora
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.
Fentanyl buccal may also be used for purposes other than those listed in this medication
guide.
What is the most important information I should know about fentanyl
buccal?
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.
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.
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.
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.
You should 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.
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.
Avoid drinking alcohol, or using other medicines that make you sleepy (such as cold
medicine, other pain medication, muscle relaxers, and medicine for seizures, depression or
anxiety). They can add to sleepiness caused by fentanyl and may cause extreme drowsiness or
breathing problems.
What should I discuss with my healthcare provider before using fentanyl
buccal?
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.
Before using this medication, tell your doctor if you are allergic to any drugs, or if
you have:
-
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.
If you have any of these conditions, you may not be able to use
fentanyl buccal, or you may need a dosage adjustment or special tests during treatment.
You should not use this medication 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.
FDA pregnancy category C. This medication may be harmful to an unborn baby, and
could cause addiction or withdrawal symptoms in a newborn. 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.
Older adults may be more likely to have side effects from this medicine.
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 take a second dose of this medication 30 minutes after the
first dose. 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.
Fentanyl can cause constipation. Talk with your doctor about increasing the amount
of fiber and water in your diet, or using a stool softener to prevent constipation.
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 skin patches 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. Symptoms of a fentanyl overdose 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 buccal.
Avoid using other medicines that make you sleepy (such as cold medicine, other pain
medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to
sleepiness caused by fentanyl and may cause extreme drowsiness or breathing problems.
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.
Continue using fentanyl buccal and talk with your doctor if you have
any of these less serious side effects:
-
nausea, vomiting, stomach pain, constipation;
-
dizziness, drowsiness, headache;
-
swelling; or
-
pain or mouth sores where the tablet was placed.
Side effects other than those listed here may also occur. Talk to your
doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect fentanyl buccal?
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);
-
antibiotics such as clarithromycin (Biaxin), erythromycin
(E-Mycin Ery-Tab, E.E.S.), troleandomycin (TAO), fluconazole (Diflucan), itraconazole
(Sporanox), or ketoconazole (Nizoral); or
-
HIV medicines such as amprenavir (Agenerase),
fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept).
If you are using any of these drugs, you may not be able to use fentanyl
buccal, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect 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 has information about fentanyl buccal written for health professionals
that you may read.
What does fentanyl buccal look like?
Fentanyl buccal is available with a prescription under the brand name Fentora. Other
brand or generic formulations may also be available. Ask your pharmacist any questions you
have about this medication, especially if it is new to you.
-
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.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 1/14/07 2:21:46 PM.
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