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Impax Laboratories Launches Oxymorphone Hydrochloride Extended-Release Tablets

Stocks in this article: IPXL

To further reduce the risk of respiratory depression, consider the following:

  • Proper dosing and titration are essential and oxymorphone hydrochloride extended-release tablets should only be prescribed by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
  • Instruct patients to swallow oxymorphone hydrochloride extended-release tablets intact. The tablets are not to be crushed, dissolved, or chewed. The resulting oxymorphone dose may be fatal, particularly in opioid-naïve individuals.
  • Oxymorphone hydrochloride extended-release tablets are contraindicated in patients with respiratory depression and in patients with conditions that increase the risk of life-threatening respiratory depression.

Accidental ExposureAccidental consumption of oxymorphone hydrochloride extended-release tablets, especially in children, can result in a fatal overdose of oxymorphone.

Interaction with AlcoholThe co-ingestion of alcohol with oxymorphone hydrochloride extended-release tablets can result in an increase of oxymorphone plasma levels and potentially fatal overdose of oxymorphone. Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products containing alcohol while on oxymorphone hydrochloride extended-release tablets therapy.

Elderly, Cachectic, and Debilitated PatientsRespiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics due to poor fat stores, muscle wasting, or altered clearance compared to younger, healthier patients. Therefore, monitor such patients closely, particularly when initiating and titrating oxymorphone hydrochloride extended-release tablets and when oxymorphone hydrochloride extended-release tablets are given concomitantly with other drugs that depress respiration.

Use in Patients with Chronic Pulmonary DiseaseMonitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with oxymorphone hydrochloride extended-release tablets, as in these patients, even usual therapeutic doses of oxymorphone hydrochloride extended-release tablets may decrease respiratory drive to the point of apnea. Consider the use of alternative non-opioid analgesics in these patients if possible.

Interactions with CNS Depressants and Illicit DrugsHypotension, profound sedation, coma, or respiratory depression may result if oxymorphone hydrochloride extended-release tablets are used concomitantly with other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). When considering the use of oxymorphone hydrochloride extended-release tablets in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. Additionally, consider the patient’s use, if any, of alcohol or illicit drugs that cause CNS depression. If oxymorphone hydrochloride extended-release tablets therapy is to be initiated in a patient taking a CNS depressant, start with a lower oxymorphone hydrochloride extended-release tablets dose than usual and monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant.

Use in Patients with Hepatic ImpairmentA study of oxymorphone hydrochloride extended-release tablets in patients with hepatic disease indicated greater plasma concentrations than those with normal hepatic function. Oxymorphone hydrochloride extended-release tablets are contraindicated in patients with moderate or severe hepatic impairment. In patients with mild hepatic impairment reduce the starting dose to the lowest dose and monitor for signs of respiratory and central nervous system depression.

Hypotensive EffectOxymorphone hydrochloride extended-release tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g. phenothiazines or general anesthetics). Monitor these patients for signs of hypotension after initiating or titrating the dose of oxymorphone hydrochloride extended-release tablets. In patients with circulatory shock, oxymorphone hydrochloride extended-release tablets may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of oxymorphone hydrochloride extended-release tablets in patients with circulatory shock.

Use in Patients with Head Injury or Increased Intracranial PressureMonitor patients taking oxymorphone hydrochloride extended-release tablets who may be susceptible to the intracranial effects of CO 2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with oxymorphone hydrochloride extended-release tablets. Oxymorphone hydrochloride extended-release tablets may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure . Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of oxymorphone hydrochloride extended-release tablets in patients with impaired consciousness or coma.

Use in Patients with Gastrointestinal ConditionsOxymorphone hydrochloride extended-release tablets are contraindicated in patients with paralytic ileus. Avoid the use of oxymorphone hydrochloride extended-release tablets in patients with other GI obstruction.

The oxymorphone in oxymorphone hydrochloride extended-release tablets may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Opioids may cause increases in the serum amylase.

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