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Impax Laboratories Launches Oxymorphone Hydrochloride Extended-Release Tablets

Use in Patients with Convulsive or Seizure DisordersThe oxymorphone in oxymorphone hydrochloride extended-release tablets may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control during oxymorphone hydrochloride extended-release tablets therapy.

Avoidance of WithdrawalAvoid the use of mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) in patients who have received or are receiving a course of therapy with an opioid agonist analgesic, including oxymorphone hydrochloride extended-release tablets. In these patients, mixed agonists/antagonists analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

When discontinuing oxymorphone hydrochloride extended-release tablets, gradually taper the dose. Do not abruptly discontinue oxymorphone hydrochloride extended-release tablets.

Driving and Operating MachineryOxymorphone hydrochloride extended-release tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of oxymorphone hydrochloride extended-release tablets and know how they will react to the medication.

ADVERSE REACTIONSThe following serious adverse reactions are discussed elsewhere in the labeling:
  • Respiratory Depression
  • Chronic Pulmonary Disease
  • Head Injuries and Increased Intracranial Pressure
  • Interactions with Other CNS Depressants
  • Hypotensive Effect
  • Gastrointestinal Effects
  • Seizures

Clinical Trial ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of oxymorphone hydrochloride extended-release tablets were evaluated in a total of 2011 patients in open-label and controlled clinical trials. The clinical trials enrolled of patients with moderate to severe chronic non-malignant pain, cancer pain, and post surgical pain. The most common serious adverse events reported with administration of oxymorphone hydrochloride extended-release tablets were chest pain, pneumonia and vomiting.

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