"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Acute overdosage with OPANA (oxymorphone hydrochloride) is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and sometimes bradycardia and hypotension. In some cases, apnea, circulatory collapse, cardiac arrest, and death may occur.
OPANA (oxymorphone hydrochloride) may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see CLINICAL PHARMACOLOGY].
In the treatment of OPANA (oxymorphone hydrochloride) overdosage, primary attention should be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and 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 hydrochloride is a specific antidote against respiratory depression that may result from overdosage or unusual sensitivity to opioids including OPANA (oxymorphone hydrochloride) . Nalmefene is an alternative pure opioid antagonist, which may be administered as a specific antidote to respiratory depression resulting from opioid overdose. Since the duration of action of OPANA (oxymorphone hydrochloride) may exceed that of the antagonist, keep the patient under continued surveillance and administer repeated doses of the antagonist according to the antagonist labeling as needed to maintain adequate respiration.
In patients receiving OPANA (oxymorphone hydrochloride) , opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression. Administer opioid antagonists cautiously to persons who are known, or suspected to be, physically dependent on any opioid agonist including OPANA (oxymorphone hydrochloride) . In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute abstinence syndrome. 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 syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. If respiratory depression is associated with muscular rigidity, administration of a neuromuscular blocking agent may be necessary to facilitate assisted or controlled ventilation. Muscular rigidity may also respond to opioid antagonist therapy.
- OPANA (oxymorphone hydrochloride) is contraindicated in patients with a known hypersensitivity to oxymorphone or to any of the other ingredients in OPANA (oxymorphone hydrochloride) , or with known hypersensitivity to morphine analogs such as codeine.
- OPANA (oxymorphone hydrochloride) is contraindicated in patients with respiratory depression, except in monitored settings and in the presence of resuscitative equipment.
- OPANA (oxymorphone hydrochloride) is contraindicated in patients with acute or severe bronchial asthma or hypercarbia.
- OPANA (oxymorphone hydrochloride) is contraindicated in any patient who has or is suspected of having paralytic ileus [see WARNINGS AND PRECAUTIONS].
- OPANA (oxymorphone hydrochloride) is contraindicated in patients with moderate or severe hepatic impairment [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 3/28/2011
This monograph has been modified to include the generic and brand name in many instances.
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