"The the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) will review the risks and benefits of modified- and prolonged-release paracetamol (acetaminophen) tablets, the agency said today.
Signs And Symptoms
Acute overdose with OXECTA can be manifested 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 in some cases, pulmonary edema, bradycardia, hypotension, cardiac arrest and death.
Oxycodone HCl 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.
To treat OXECTA overdose, primary attention must be given to the re-establishment of a patent airway and institution of assisted or controlled ventilation. Supportive measures (including oxygen and vasopressors) must 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 pure opioid antagonist naloxone is a specific antidote to respiratory depression resulting from opioid overdose. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to OXECTA overdose. If needed, the appropriate dose of naloxone HCl should be administered simultaneously with efforts at respiratory resuscitation (see prescribing information for naloxone HCl for the details).
Since the duration of action of OXECTA is expected to exceed that of the antagonist, the patient must be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Opioid antagonists must be administered cautiously to persons who are suspected to be physically dependent on any opioid agonist, including oxycodone (see Opioid-Tolerant Individuals).
Opioid-Tolerant Individuals: In an individual physically dependent on opioids, administration of a usual dose of antagonist will precipitate an acute withdrawal. The severity of the withdrawal syndrome produced will depend on the degree of physical dependence and the dose of the antagonist administered. Reserve use of an opioid antagonist for cases where such treatment is clearly needed. If it is necessary to treat serious respiratory depression in the physically dependent patient, initiate administration of the antagonist with care and by titration with smaller than usual doses.
OXECTA is contraindicated in patients with respiratory depression in unmonitored settings and in the absence of resuscitative equipment.
OXECTA is contraindicated in any patient who has or is suspected of having paralytic ileus.
OXECTA is contraindicated in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/28/2016
Additional Oxecta Information
- Oxecta Drug Interactions Center: oxycodone oral
- Oxecta Side Effects Center
- Oxecta FDA Approved Prescribing Information including Dosage
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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