Avinza Overdosage

Symptoms

Acute overdosage with morphine is 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, and death.

Treatment

Primary attention should be given to re-establishment of a patent airway and institution of assisted or controlled ventilation when overdose of an extended-release formulation such as AVINZA has been ingested. Elimination or evacuation of gastric contents may be necessary in order to eliminate unabsorbed drug. Before attempting treatment by gastric emptying or activated charcoal, care should be taken to secure the airway. Pure opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. Since the duration of reversal is expected to be less than the duration of action of AVINZA, the patient must be carefully monitored until spontaneous respiration is reliably re-established. AVINZA, as with other controlled delivery preparations in overdose situations, may continue to release morphine for 36 to 48 hours or longer following ingestion, and management of an overdose should be monitored accordingly. If the response to opioid antagonists is sub-optimal or only brief in nature, additional antagonist should be administered as directed by the manufacturer of the product.

Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to morphine overdose. Such agents should be administered cautiously to persons who are known, or suspected to be physically dependent on AVINZA. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome.

Opioid-Tolerant Individuals: In an individual physically dependent on opioids, administration of the usual dose of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. Use of an opioid antagonist should be reserved for cases where such treatment is clearly needed. If it is necessary to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and titrated with smaller than usual doses.

Supportive measures (including oxygen, vasopressors) should be employed in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.

AVINZA is contraindicated in patients with known hypersensitivity to morphine, morphine salts, or any components of the product. AVINZA, like all opioids, is contraindicated in patients with respiratory depression in the absence of resuscitative equipment and in patients with acute or severe bronchial asthma.

AVINZA, like all opioids, is contraindicated in any patient who has or is suspected of having paralytic ileus.

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