April 27, 2017
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Zohydro ER

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Zohydro ER

Overdosage
Contraindications

OVERDOSE

Clinical Presentation

Acute overdosage with ZOHYDRO ER can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see CLINICAL PHARMACOLOGY].

Treatment Of Overdose

In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation if needed. Employ other 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.

The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdosage. For clinically significant respiratory or circulatory depression secondary to hydrocodone overdose, administer an opioid antagonist.

Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to hydrocodone overdose.

Because the duration of reversal is expected to be less than the duration of action of hydrocodone in ZOHYDRO ER, carefully monitor the patient until spontaneous respiration is reliably reestablished. ZOHYDRO ER will continue to release hydrocodone and add to the hydrocodone load for 24 to 48 hours or longer following ingestion necessitating prolonged monitoring. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.

In an individual physically dependent on opioids, administration of the recommended dose of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.

CONTRAINDICATIONS

ZOHYDRO ER is contraindicated in patients with:

  • Significant respiratory depression [see WARNINGS AND PRECAUTIONS]
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS AND PRECAUTIONS]
  • Known or suspected gastrointestional obstruction, including paralytic ileus [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity (e.g., anaphylaxis) to hydrocodone or any other ingredients in ZOHYDRO ER
This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/6/2017

Overdosage
Contraindications

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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