"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
(Generic versions may still be available.)
Ionsys Patient Information including How Should I Take
In this Article
- What is fentanyl transdermal (Ionsys)?
- What are the possible side effects of fentanyl transdermal (Ionsys)?
- What is the most important information I should know about a fentanyl transdermal device (Ionsys)?
- What should I discuss with my healthcare provider before using a fentanyl transdermal device (Ionsys)?
- How is a fentanyl transdermal device used (Ionsys)?
- What happens if I miss a dose (Ionsys)?
- What happens if I overdose (Ionsys)?
- What should I avoid while using a fentanyl transdermal device (Ionsys)?
- What other drugs will affect fentanyl transdermal (Ionsys)?
- Where can I get more information?
What should I discuss with my healthcare provider before using a fentanyl transdermal device (Ionsys)?
Do not use this medication unless you are already being treated with a similar opioid (narcotic) 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.
Before you receive 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 need a dose adjustment or special tests to safely use this medication.
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 transdermal 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 transdermal may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction.
How is a fentanyl transdermal device used (Ionsys)?
The fentanyl transdermal device is used only while you are in a hospital. You will not be allowed to use the device at home. Do not leave the hospital with a device on your skin.
If the skin must be washed before fentanyl transdermal 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 transdermal. These substances could increase the amount of fentanyl that your skin absorbs, possibly causing harmful effects.
The 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 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 device will allow you to give yourself up to 6 doses per hour. Do not allow others to press the dosing button for you.
The fentanyl transdermal device may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the device before undergoing such a test.
Additional Ionsys Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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