IMPORTANT RISK INFORMATION
- Oxymorphone is contraindicated in patients with:
- Known hypersensitivity to oxymorphone or to any of the other ingredients in oxymorphone hydrochloride tablets, or with known hypersensitivity to morphine analogs such as codeine
- Respiratory depression, except in monitored settings and in the presence of resuscitative equipment.
- Acute or severe bronchial asthma or hypercarbia
- Known or suspected paralytic ileus
- Moderate or severe hepatic impairment
WARNINGS AND PRECAUTIONS
- Respiratory depression is the chief hazard from all opioid agonist preparations. In some patients, usual therapeutic doses of opioids may cause respiratory depression. Patients with pulmonary conditions and pre-existing respiratory depression are at the highest risk.
- Respiratory depression may occur more frequently in elderly or debilitated patients as well as in those suffering from conditions accompanied by hypoxia or hypercapnia, when even moderate therapeutic doses may dangerously decrease pulmonary ventilation.
- Oxymorphone hydrochloride tablets contain oxymorphone, a mu opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. Opioid agonists are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.
- The concomitant use of other CNS depressants including other opioids, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, and alcohol with oxymorphone may produce increased depressant effects including hypoventilation, hypotension, profound sedation, coma and death.
- Opioid analgesics may cause physical dependence. Physical dependence results in withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an opioid antagonist or mixed opioid agonist/antagonist agent. The respiratory depressant effects of oxymorphone may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure.
- Oxymorphone may obscure the clinical course of patients with head injuries or acute abdominal conditions.
- Oxymorphone may cause severe hypotension in a patient whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents that compromise vasomotor tone. Administer oxymorphone hydrochloride tablets with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.
- Use oxymorphone hydrochloride tablets with caution in patients with mild hepatic impairment, starting with the lowest dose and titrating slowly while carefully monitoring for side effects. Use oxymorphone hydrochloride tablets with caution in the following conditions: adrenocortical insufficiency (e.g., Addison’s disease), prostatic hypertrophy or urethral stricture, severe impairment of pulmonary or renal function, and toxic psychosis.
- Opioids may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings.
- Opioids diminish propulsive peristaltic waves in the gastrointestinal tract and may result in decreased bowel motility.
- Oxymorphone hydrochloride tablets, like other opioids, may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.
- Opioid analgesics impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
- Serious adverse reactions may include respiratory depression, tachycardia, hypoxia, hypotension and convulsions. Other serious adverse reactions, where there is a greater risk in patients taking concomitant CNS depressants, may include hypoventilation, profound sedation, coma and death.
- The most common adverse reactions include nausea, pyrexia, somnolence, vomiting, pruitus, headache, dizziness, constipation and confusion.
USE IN SPECIFIC POPULATIONS
- Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal symptoms.
- Breast feeding: it is not known if oxymorphone is excreted in human milk.
- Pediatrics: safety and effectiveness in pediatric patients below the age of 18 have not been established.
Pink round tablet
Opana® 10 mg tablet
Debossed “1010” on one side and “M” in a box on the other side.
For additional information on Oxymorphone HCl IR 10 mg tablets, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.
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