Fentanyl is a narcotic (opioid) pain medicine.

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.

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.

Your pharmacist has additional information about fentanyl topical written for health professionals that you may read.

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