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DRUG DESCRIPTION
IONSYS™ (fentanyl iontophoretic transdermal system) is a patient-controlled iontophoretic transdermal system providing on-demand systemic delivery of fentanyl, an opioid agonist, for up to 24 hours or a maximum of 80 doses, whichever comes first.
The chemical name is propanamide, N-phenyl-N-[1-(2-phenylethyl)-4- piperidinyl] monohydrochloride. The structural formula is:
The molecular weight of fentanyl hydrochloride is 372.93, and the empirical formula is C22H28N2O??· HCl. The n-octanol:water partition coefficient is 860:1; the pKa is 8.4.
The active ingredient in IONSYS (fentanyl iontophoretic transdermal system) ™ is fentanyl. IONSYS (fentanyl iontophoretic transdermal system) ™ contains 10.8 mg of fentanyl hydrochloride equivalent to 9.7 mg of fentanyl. IONSYS (fentanyl iontophoretic transdermal system) ™ is designed to deliver a 40-mcg dose of fentanyl (equivalent to 44.4 mcg of fentanyl hydrochloride) over a 10-minute period upon each activation of the dose button (see DOSAGE AND ADMINISTRATION).
The inactive ingredients in the IONSYS (fentanyl iontophoretic transdermal system) ™ hydrogels consist of cetylpyridinium chloride, USP; citric acid, USP; polacrilin; polyvinyl alcohol; sodium citrate, USP; sodium chloride, USP; sodium hydroxide; and purified water, USP.
System Components and Structure
Each IONSYS (fentanyl iontophoretic transdermal system) ™ system is composed of a plastic top housing that contains the battery and electronics, and a red plastic bottom housing containing two hydrogel reservoirs and a polyisobutylene skin adhesive. Only one of the hydrogels (the anode, located under the dosing button) contains fentanyl HCl, along with inactive ingredients. The other hydrogel (the cathode) contains only pharmacologically inactive ingredients. The bottom housing has a red tab that is used only for system removal from the skin and during disposal (see DOSAGE AND ADMINISTRATION, Disposal). A siliconized clear, plastic release liner covers the hydrogels and must be removed and discarded prior to placement on the skin. The system is powered by a 3-volt lithium battery.
IONSYS™
(fentanyl iontophoretic transdermal system)
What are the possible side effects of fentanyl transdermal (Ionsys)?
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.
Tell your caregivers right away 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.
Less serious side effects may include:
- nausea, vomiting, stomach pain,...
Read All Potential Side Effects and See Pictures of Ionsys »
Ionsys Patient Information Including Side Effects
Brand Names: Ionsys
Generic Name: fentanyl transdermal (device) (Pronunciation: FEN ta nil trans DERM al)
- 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 is fentanyl transdermal (Ionsys)?
Fentanyl is a narcotic (opioid) pain medicine.
The fentanyl transdermal device is used only in a hospital to treat acute pain after surgery.
Fentanyl transdermal may be used for other purposes not listed in this medication guide.
What are the possible side effects of fentanyl transdermal (Ionsys)?
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.
Tell your caregivers right away 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.
Less serious side effects may include:
- nausea, vomiting, stomach pain, constipation, gas;
- dizziness, drowsiness, anxiety, sleep problems (insomnia);
- muscle stiffness, back pain;
- itching, blistering, redness, or swelling where the patch or device was worn; or
- increased sweating, urinating less than usual.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about a fentanyl transdermal device (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.
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. Talk with your doctor if you are not sure you are opioid-tolerant.
Fentanyl 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.
Avoid drinking alcohol, or using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxers, and medicine for depression or anxiety). They can add to extreme drowsiness or breathing problems caused by fentanyl.
- Ionsys
Related Drugs Index:
Fentanyl, Iontophoretic, Transdermal, System, Ionsys, Buy Ionsys