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Ionsys (Fentanyl Hydrochloride Transdermal) - Drug Interactions, Contraindications, Overdosage, etc



Drug Interactions

Central Nervous System Depressants

The concomitant use of other central nervous system depressants, including other opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, or alcoholic beverages, may produce additive depressant effects. Hypoventilation, hypotension, profound sedation, coma, or death may occur. Therefore, use of concomitant CNS depressants requires individual adjustment of dosage of the concomitant medication and observation of a given patient.


Clinical Presentation

The manifestations of fentanyl overdosage are an extension of its pharmacologic actions, with the most serious effect being respiratory depression.


For the management of respiratory depression, immediate countermeasures include removing IONSYS™ and discontinuing administration of any other opiates until the episode has resolved, as well as physically or verbally stimulating the patient. If needed, these actions can be followed by administration of a specific narcotic antagonist such as naloxone. Reversal of the narcotic effect may result in acute onset of pain and the release of catecholamines.

If the clinical situation warrants, ensure a patent airway is established and maintained, administer oxygen and assist or control respiration as indicated, and use an oropharyngeal airway or endotracheal tube if necessary. Adequate body temperature and fluid intake should be maintained.

If severe or persistent hypotension occurs, the possibility of hypovolemia should be considered and managed with appropriate parenteral fluid therapy.


IONSYS™ is contraindicated in patients with known hypersensitivity to fentanyl, cetylpyridinium chloride (e.g. Cepacol®) or any components of the IONSYS™ system.


Controlled Substance

IONSYS™ contains fentanyl, a Schedule II controlled substance.


IONSYS™ contains a high concentration of a potent Schedule II controlled opioid agonist, fentanyl. Schedule II opioid substances, which include fentanyl, morphine, oxycodone, oxymorphone, hydromorphone, and methadone, have the highest potential for abuse. These drugs also have a risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high drug content and concentrated formulation of fentanyl in IONSYS™ may be a particular target for abuse and diversion and may add to the risk of adverse outcomes from abuse. After the maximum dosage administration, a significant amount of fentanyl remains in the device.

Access to abusable drugs such as IONSYS™ presents a risk for abuse and diversion in the health care community. Implementation of effective accounting procedures in addition to routine procedures for handling controlled substances may minimize these risks.


Tolerance and physical and psychological dependence may develop upon repeated administration of opioids. Iatrogenic addiction following opioid administration is relatively rare. Physicians should not let concerns of physical dependence deter them from using adequate amounts of opioids in the management of acute post-operative pain when such use is indicated.

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