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
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