Consumer Information

Ionsys

Generic name: Fentanyl iontophoretic
Brand names: Ionsys

Why is Ionsys prescribed?

Ionsys is used for short-term treatment of pain after surgery in adults 18 years and older.

Most important fact about Ionsys

Ionsys should not come into contact with fingers or the mouth; this contact could lead to an overdose of fentanyl, possibly resulting in death.

How should you take Ionsys?

Only you should administer doses from Ionsys. Ionsys should be applied to clean, dry, unbroken skin on the chest or upper arm. Each on-demand dose is delivered over a 10-minute period. To initiate the dose of fentanyl, press the button twice firmly within 3 seconds. An audible tone (beep) indicates the start of delivery of each dose; the red light remains on throughout the 10-minute dosing period.

Storage instructions...
Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Ionsys.

Side effects may include:
Application site reaction, fever, headache, nausea, vomiting

Why should Ionsys not be prescribed?

Do not begin treatment with Ionsys if you are allergic to fentanyl, cetylpyridinium chloride, or any of its other ingredients.

Do not use Ionsys for the pain of labor or delivery.

Special warnings about Ionsys

Avoid touching the hydrogel that makes up Ionsys. Contact with your fingers or mouth may result in a fatal overdose of fentanyl.

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Ionsys. Also, talk to your doctor about your complete medical history, especially if you have heart, kidney, or liver problems.

Possible food and drug interactions when taking Ionsys

If Ionsys is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Ionsys with the following:

Alcohol
Antihistamines
Central nervous system (CNS) depressants
General anesthetics
Hypnotics
Muscle relaxants
Opioids
Phenothiazines
Sedatives
Tranquilizers

Special information if you are pregnant or breastfeeding

The effects of Ionsys during pregnancy are unknown. Talk with your doctor before taking Ionsys if you are pregnant or plan to become pregnant. This drug should not be used for labor/delivery pain. Also, fentanyl passes into breast milk; therefore, it may cause severe breathing problems or sedation in infants.

Recommended dosage for Ionsys

ADULTS

The usual dosage of Ionsys is 40 micrograms (mcg) per 10-minute dose. The maximum is six 40-mcg doses per hour.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately. Symptoms of Ionsys overdose may include breathing problems.