"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.)
(fentanyl hydrochloride) Patch, Extended Release, Electrically Controlled
* Equals to 44.4 mcg fentanyl HC1
IONSYS™ should only be used for the treatment of hospitalized patients. Treatment with IONSYS™ should be discontinued before patients are discharged from the hospital.
Treatment with fentanyl, the active component of IONSYS™, may result in potentially life-threatening respiratory depression and death. To avoid potential overdosing, only the patient should activate IONSYS™ dosing.
Inappropriate use of IONSYS™, leading to ingestion or contact with mucous membranes or unintended exposure to the fentanyl hydrogel could lead to the absorption of a potentially fatal dose of fentanyl. Therefore, the hydrogels should not come into contact with fingers or mouth.
IONSYS™ contains fentanyl, a potent opioid agonist and Schedule II controlled substance with high potential for abuse similar to hydromorphone, methadone, morphine, and oxycodone. Fentanyl can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing IONSYS™ in situations where the Health Care Professional is concerned about an increased risk of misuse, abuse, or diversion. After the maximum dosage administration, a significant amount of fentanyl remains in the device.
IONSYS™ should always be kept out of reach of children.
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-[l-(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™ is fentanyl HC1, which is equivalent to 40 mcg per dose of fentanyl free base. IONSYS™ contains 10.8 mg of fentanyl hydrochloride equivalent to 9.7 mg of fentanyl. IONSYS™ 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™ 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™ 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 HC1, 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.
(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, constipation, gas;
- dizziness, drowsiness, anxiety, sleep problems...
Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.
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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