"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"...
Acute overdosage with opioids can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes bradycardia, hypotension and death. The pharmacokinetic characteristics of DURAGESIC must also be taken into account when treating the overdose. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects. Deaths due to overdose have been reported with abuse and misuse of DURAGESIC.
Give primary attention to the reestablishment of a patent airway and institution of assisted or controlled ventilation. Employ supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques. Remove all DURAGESIC systems.
The pure opioid antagonists, such as naloxone, are specific antidotes to respiratory depression from opioid overdose. Since the duration of reversal is expected to be less than the duration of action of fentanyl, carefully monitor the patient until spontaneous respiration is reliably reestablished. After DURAGESIC system removal, serum fentanyl concentrations decline gradually, falling about 50% in approximately 20-27 hours. Therefore, management of an overdose must be monitored accordingly, at least 72 to 96 hours beyond the overdose.
Only administer opioid antagonists in the presence of clinically significant respiratory or circulatory depression secondary to hydromorphone overdose. In patients who are physically dependent on any opioid agonist including DURAGESIC, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Please see the prescribing information for the specific opioid antagonist for details of their proper use.
DURAGESIC is contraindicated in the following patients and situations due to the risk of fatal respiratory depression:
- in patients who are not opioid-tolerant [see WARNINGS AND PRECAUTIONS].
- in the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time [see WARNINGS AND PRECAUTIONS].
- in the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies) [see WARNINGS AND PRECAUTIONS].
- in the management of mild pain [see WARNINGS AND PRECAUTIONS].
- in patients with significant respiratory compromise, especially if adequate monitoring and resuscitative equipment are not readily available [see WARNINGS AND PRECAUTIONS].
- in patients who have acute or severe bronchial asthma [see WARNINGS AND PRECAUTIONS].
DURAGESIC is also contraindicated:
- in patients who have or are suspected of having paralytic ileus
- in patients with known hypersensitivity to fentanyl or any components of the transdermal system. Severe hypersensitivity reactions, including anaphylaxis have been observed with DURAGESIC [see ADVERSE REACTIONS].
Last reviewed on RxList: 10/29/2013
This monograph has been modified to include the generic and brand name in many instances.
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