Clinical Presentation

The manifestations of fentanyl overdosage are an extension of its pharmacologic actions with the most serious significant effect being hypoventilation.

Treatment

For the management of hypoventilation, immediate countermeasures include removing the DURAGESIC® (fentanyl transdermal system) system and physically or verbally stimulating the patient. These actions can be followed by administration of a specific narcotic antagonist such as naloxone. The duration of hypoventilation following an overdose may be longer than the effects of the narcotic antagonist's action (the half-life of naloxone ranges from 30 to 81 minutes). The interval between IV antagonist doses should be carefully chosen because of the possibility of re-narcotization after system removal; repeated administration of naloxone may be necessary. Reversal of the narcotic effect may result in acute onset of pain and the release of catecholamines.

Always 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.

Because serious or life-threatening hypoventilation could occur, DURAGESIC® (fentanyl transdermal system) is contraindicated:

• in patients who are not opioid-tolerant
• in the management of acute pain or in patients who require opioid analgesia for a short period of time
• in the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies)
• in the management of mild pain
• in the management of intermittent pain (e.g., use on an as needed basis [prn])
• in situations of significant respiratory depression, especially in unmonitored settings where there is a lack of resuscitative equipment
• in patients who have acute or severe bronchial asthma

DURAGESIC® (fentanyl transdermal system) is contraindicated in patients who have or are suspected of having paralytic ileus.

DURAGESIC® (fentanyl transdermal system) is contraindicated in patients with known hypersensitivity to fentanyl or any components of this product.

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