July 26, 2016
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Clinical Presentation

The manifestations of SUBSYS overdosage are expected to be similar in nature to intravenous fentanyl and other opioids, and are an extension of its pharmacological actions with the most serious significant effect being respiratory depression [see CLINICAL PHARMACOLOGY].

Immediate Management

Immediate management of opioid overdose includes ensuring a patent airway, physical and verbal stimulation of the patient, and assessment of level of consciousness, ventilatory and circulatory status.

Treatment Of Overdosage (Accidental Ingestion) In The Opioid NON-Tolerant Person

Provide ventilatory support, obtain intravenous access, and administer naloxone or other opioid antagonists as clinically indicated. The duration of respiratory depression following overdose may be longer than the effects of the opioid antagonist's action (e.g., the half-life of naloxone ranges from 30 to 81 minutes) and repeated administration may be necessary. Consult the package insert of the individual opioid antagonist for details about such use.

Treatment Of Overdose In Opioid-Tolerant Patients

Provide ventilatory support and obtain intravenous access as clinically indicated. Judicious use of naloxone or another opioid antagonist may be warranted in some instances, but it is associated with the risk of precipitating an acute withdrawal syndrome.

General Considerations For Overdose

Management of SUBSYS overdose includes: securing a patent airway, assisting or controlling ventilation, establishing intravenous access. In the presence of respiratory depression or apnea, assist or control ventilation, and administer oxygen as indicated.

Carefully observe and appropriately manage overdosed patients until their clinical condition is well controlled.

Although muscle rigidity interfering with respiration has not been seen following the use of SUBSYS, this is possible with fentanyl and other opioids. If it occurs, manage by the use of assisted or controlled ventilation, by the administration of an opioid antagonist, and, as a final alternative, by the administration of a neuromuscular blocking agent.


SUBSYS is contraindicated:

  • in opioid non-tolerant patients.
  • in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression and death could occur at any dose in opioid non-tolerant patients.
  • in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl. Anaphylaxis and hypersensitivity have been reported in association with the use of other oral transmucosal fentanyl products.
This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/25/2016


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