The Duragesic fentanyl skin patch is used to treat moderate to severe
chronic pain. The Ionsys fentanyl transdermal device is used only in a hospital
to treat acute pain after surgery.
Fentanyl topical may also be used for purposes other than those listed in this medication
guide.
This medication is for use only on the skin. Avoid touching the sticky side of a skin
patch or the gel inside a transdermal device. Do not allow the medicine to come into contact
with your eyes, nose, mouth, or lips. If it does, rinse with water. Do not use soap or other
chemicals.
Use this medication exactly as it was prescribed for you. Do not use the medication in
larger or smaller amounts, or use it for longer than recommended by your doctor. Using too
much fentanyl can be very harmful or fatal.
Ionsys transdermal devices are used only while you are in a hospital. You will not be
allowed to use the devices at home. Do not leave the hospital with a device on your skin.
Duragesic skin patches may be used at home. Read all patient instructions carefully
before using the patches. Ask your doctor or pharmacist if you have questions.
If the skin must be washed before fentanyl topical is applied, use clear water only. Allow
the skin to dry completely before applying the medicine.
Do not use soaps, oils, lotions, alcohol, or other chemicals on the skin where you will
apply fentanyl topical. These substances could increase the amount of fentanyl that your skin
absorbs, possibly causing harmful effects.
Apply the skin patch to a flat, dry, hairless area of the chest, back, side,
or outer side of your upper arm. To remove any hair from these areas, clip the hair short but do
not shave it. Press the patch firmly with the palm of your hand for 30 seconds. Make sure the
patch is sticking firmly, especially around the edges. You may wear the patch for up to 72 hours.
Do not wear more than 1 patch at a time.
After removing a skin patch fold it in half, sticky side in, and flush the patch down the
toilet. Apply a new patch to a different skin area on the chest, back, side, or upper arm. Do not
use the same skin area twice in a row.
The transdermal device will be applied where you can reach it, such as
your chest or the outer side of your upper arm. The device is worn for 24 hours or until the device
has delivered 80 doses of fentanyl.
To release the medicine from the transdermal device, press the dosing button twice. The
device will sound a beep when the dose starts, and a red light will come on for 10 minutes while
the dose is delivered. The light will also flash between doses to let your caregivers know how
many doses are left in the device. Tell your care provider if the patch comes loose or falls off.
The transdermal device will allow you to give yourself up to 6 doses per hour. Do
not allow others to press the dosing button for you.
Increase the amount of fiber and water in your diet to prevent constipation.
Keep each skin patch in its foil pouch until you are ready to use it. If the pouch seal is
already broken, do not use the patch. After removing a patch from the foil pouch, apply the patch
to your skin right away.
Do not use a fentanyl topical skin patch or device if the patch or device has
been cut or damaged. Doing so could expose you to too much fentanyl, which can
cause a life-threatening overdose.
Keep both used and unused fentanyl topical patches or devices out of the reach of
children or pets. The amount of fentanyl in these units can be fatal to a child or pet
who accidentally sucks on or swallows the unit. 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.
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 topical and call your doctor at once if you have any of these
serious side effects:
weak, shallow breathing;
severe weakness, feeling light-headed or fainting;
cold, clammy skin; or
pale skin, easy bruising or bleeding.
Continue using fentanyl topical and talk with your doctor if you have
any of these less serious side effects:
itching, blistering, redness, or swelling where the patch or
device was worn; or
increased sweating, urinating less than usual.
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.
Before using this medication, tell your doctor if you are using any of the following drugs:
carbamazepine (Tegretol, Carbatrol);
phenytoin (Dilantin);
St. John’s wort;
rifampin (Rifater, Rifamate, Rimactane);
antibiotics such as clarithromycin (Biaxin), erythromycin
(E-Mycin Ery-Tab, E.E.S.), itraconazole (Sporanox), or ketoconazole (Nizoral); or
HIV medicines such as amprenavir (Agenerase), tipranavir
(Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra),
fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept).
There may be other drugs not listed that can affect fentanyl topical.
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.
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 dizziness or drowsiness caused by
fentanyl topical.
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 topical.
Avoid exposing a fentanyl topical skin patch to heat while you are wearing it. This
includes a hot tub, heating pad, sauna, or heated water bed. Heat can increase the amount of drug
you absorb through your skin and may cause harmful effects.
Seek emergency medical attention if you think you have used too much of this
medicine or if anyone 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.
Since fentanyl topical is used as needed, you may not be on a dosing schedule. If you are
using the skin patches regularly, apply the missed patch as soon as you remember. Continue
wearing the patch for up to 72 hours and then apply a new one if needed for pain. Do not wear extra patches to make up a missed dose.
Keep both used and unused fentanyl topical patches or devices out of the reach of
children or pets. The amount of fentanyl in these units can be fatal to a child or pet
who accidentally sucks on or swallows the unit. Seek emergency medical attention if
this happens.
Before using fentanyl topical, tell your doctor if you have a breathing disorder such as
chronic obstructive pulmonary disease (COPD). You should not use fentanyl topical if you have
had an allergic reaction or severe side effects when using any narcotic pain medicine.
Fentanyl topical 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.
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 a Duragesic skin patch 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.
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.
Before using this medication, tell your doctor if you are allergic to fentanyl or any
other medications, 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;
liver disease; or
kidney disease.
If you have any of these conditions, you may not be able to use
fentanyl topical, or you may need a dosage adjustment or special tests during treatment.
You should not use a Duragesic skin patch 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 topical 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 topical 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.
Fentanyl topical is available with a prescription under the brand names Duragesic and
Ionsys. 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.
Duragesic 25 micrograms (mcg) per hour
Duragesic 50 mcg per hour
Duragesic 75 mcg per hour
Duragesic 100 mcg per hour
Ionsys 40 mcg per activation
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.
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or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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