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Embeda (Morphine Sulfate / Naltrexone Hydrochloride) - Drug Interactions, Contraindications, Overdosage, etc



EMBEDA drug label information in our database does not contain a dedicated section on drug interactions. Please check subsections of WARNINGS AND PRECAUTIONS as well as other sources.

10 OVERDOSAGE 10.1 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, sometimes, pulmonary edema, bradycardia, hypotension, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations.

10.2 Treatment

Primary attention should be given to the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation if needed. Other 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 will require advanced life support techniques.

The pure opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression which results from opioid overdose. Since the duration of reversal would be expected to be less than the duration of action of morphine in EMBEDA, the patient must be carefully monitored until spontaneous respiration is reliably re-established. EMBEDA will continue to release and add to the morphine load for up to 24 hours after administration and the management of an overdose should be monitored accordingly. If the response to opioid antagonists is suboptimal or not sustained, additional antagonist should be given 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 EMBEDA. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.

The sequestered naltrexone in EMBEDA has no role in the treatment of opioid overdose.

In an individual physically dependent on opioids, administration of an opioid receptor antagonist may precipitate an acute withdrawal. The severity of the withdrawal produced 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 begun with care and by titration with smaller than usual doses of the antagonist


EMBEDA is contraindicated in patients with a known hypersensitivity to morphine, morphine salts, naltrexone, or in any situation where opioids are contraindicated.

4.1 Impaired Pulmonary Function

EMBEDA is contraindicated in patients with significant respiratory depression in unmonitored settings or the absence of resuscitative equipment.

EMBEDA is contraindicated in patients with acute or severe bronchial asthma or hypercapnia in unmonitored settings or the absence of resuscitative equipment [see WARNINGS AND PRECAUTIONS (5.1) ].

4.2 Paralytic Ileus

EMBEDA is contraindicated in any patient who has or is suspected of having paralytic ileus.

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