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Ionsys

Generic Name: fentanyl transdermal (device) (FEN ta nil trans DERM al)
Brand Name: Ionsys

What is fentanyl transdermal?

Fentanyl is an opioid pain medication. An opioid is sometimes called a narcotic.

The fentanyl transdermal device is a patient-controlled medicine system used only in a hospital to treat acute pain after surgery. The transdermal device sticks to the skin of your arm or chest.

Fentanyl transdermal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about a fentanyl transdermal device?

You should not use a fentanyl transdermal device if you have: a severe breathing problem, or a blockage in your stomach or intestines.

The fentanyl transdermal device is used only while you are in a hospital. Do not leave the hospital with this device on your skin.

Fentanyl can slow or stop your breathing. Use this device only as directed. Never allow a family member or visitor to touch or handle the transdermal device. It should be handled only by a healthcare professional.

MISUSE OF A FENTANYL TRANSDERMAL DEVICE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a person using the medicine without a prescription. Fentanyl may also be habit-forming. Never share a transdermal device with another person, especially someone with a history of drug abuse or addiction.

Fentanyl may cause life-threatening withdrawal symptoms in a newborn if the mother uses this medicine during pregnancy.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with fentanyl.

What should I discuss with my healthcare provider before using a fentanyl transdermal device?

You should not use this medicine if you are allergic to fentanyl or to Cepacol (cetylpyridinium chloride), or if you have:

  • a severe breathing problem such as asthma attacks; or

  • a blockage in your digestive tract (stomach or intestines).

Some medicines can cause unwanted or dangerous effects when used with fentanyl. You may not be able to use this medicine if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat hepatitis C or HIV/AIDS. Tell your doctor about all medicines you use.

To make sure fentanyl transdermal is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • a history of head injury, brain tumor, mental illness, alcoholism or drug addiction;

  • slow heartbeats;

  • seizures or epilepsy;

  • urination problems;

  • liver or kidney disease; or

  • problems with your gallbladder, pancreas, or thyroid.

It is not known whether this medicine will harm an unborn baby. If you use fentanyl while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Fentanyl can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is a fentanyl transdermal device used?

Fentanyl can slow or stop your breathing. Use this device only as directed.

The fentanyl transdermal device is used only while you are in a hospital. A healthcare provider will place the device on your chest or upper arm where you can reach it. A healthcare provider should also remove or replace the device when needed. Do not leave the hospital with a device on your skin.

Fentanyl may be habit-forming, even at regular doses. Never share a transdermal device with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a person using the medicine without a prescription. Selling or giving away fentanyl is against the law.

To release the medicine from the device, press the dosing button twice. A beep will sound when the dose starts, and a green light will blink for 10 minutes while the dose is delivered. The device can only be activated once every 10 minutes. Tell your doctor if this medicine seems to stop working as well in relieving your pain.

While you are wearing this device, only you should press the dosing button to control your pain. Do not allow others to press the dosing button for you, or you could receive a fatal overdose.

Never allow a family member or visitor to touch or handle the transdermal device. It should be handled only by a healthcare professional. Do not remove or reposition the device yourself. The sticky side of the device contains a high concentration of fentanyl, which could cause a fatal overdose if the medicine gets on your skin. Tell your care provider if the device comes loose or falls off.

The device is worn for 24 hours or until it has delivered 80 doses of fentanyl.

The fentanyl transdermal device may burn your skin if you wear the device during an MRI (magnetic resonance imaging). Certain other medical tests can cause damage to the transdermal device. Remove the device before undergoing an MRI, CT scan, x-ray, or similar test.

What happens if I miss a dose?

Since a fentanyl transdermal device is applied by a healthcare professional in a hospital setting, it is not likely that you will miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

What should I avoid while using a fentanyl transdermal device?

This medication is for use only on the skin. Avoid touching the gel inside a device with your fingers. Only a healthcare provider wearing gloves should handle a fentanyl transdermal device.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with fentanyl. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Do not drive or operate machinery until you know how fentanyl has affected you. Dizziness or severe drowsiness can cause falls or other accidents.

Fentanyl transdermal side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have any of these serious side effects:

  • a light-headed feeling, like you might pass out;

  • severe weakness,

  • slow heart rate, sighing, weak or shallow breathing;

  • cold, clammy skin; or

  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Breathing problems may be more likely in older adults.

Common side effects may include:

  • nausea, vomiting;

  • feeling dizzy or light-headed;

  • headache;

  • painful or difficult urination;

  • low red blood cells; or

  • itching or redness where the device was worn.

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.

See also: Side effects (in more detail)

What other drugs will affect fentanyl transdermal?

Using this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using a sleeping pill, a sedative or tranquilizer, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not use fentanyl transdermal if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Other drugs may interact with fentanyl transdermal, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your medications and any you start or stop using during treatment with fentanyl transdermal.

Where can I get more information?

  • Your pharmacist can provide more information about fentanyl transdermal.
  • 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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision Date: 2015-08-28, 8:05:37 AM.

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