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In addition to requiring new labeling on these prescript"...
Signs and Symptoms
Signs and symptoms of acute overdosage with DILAUDID INJECTION or DILAUDIDHP INJECTION include: respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, apnea, circulatory collapse, cardiac arrest, and death.
Hydromorphone may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis, rather than miosis, may be seen with hypoxia in overdose situations.
In the treatment of overdosage, primary attention should be given to the reestablishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary edema accompanying overdose as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
The opioid antagonist, naloxone, is a specific antidote against respiratory depression which may result from overdosage, or unusual sensitivity to DILAUDID INJECTION or DILAUDID-HP INJECTION. Therefore, an appropriate dose of this antagonist should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on DILAUDID INJECTION or DILAUDID-HP INJECTION. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.
Since the duration of action of DILAUDID INJECTION and DILAUDID-HP INJECTION may exceed that of the antagonist, the patient should be kept under continued surveillance; repeated doses of the antagonist may be required to maintain adequate respiration. Apply other supportive measures when indicated.
Both DILAUDID INJECTION and DILAUDID-HP INJECTION are contraindicated:
- In patients with known hypersensitivity to hydromorphone, hydromorphone salts, any other components of the product, or sulfite-containing medications [see WARNINGS AND PRECAUTIONS, Sulfites].
- In any situation where opioids are contraindicated, e.g., in patients with respiratory depression in the absence of resuscitative equipment or in unmonitored settings; or patients with acute or severe bronchial asthma.
- In patients with, or at risk of developing, gastrointestinal obstruction, especially paralytic ileus because hydromorphone diminishes the propulsive peristaltic wave in the gastrointestinal tract and may prolong the obstruction.
DILAUDID-HP INJECTION is contraindicated in patients who are not opioid tolerant [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 8/12/2011
This monograph has been modified to include the generic and brand name in many instances.
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