warnings and cautions
5 WARNINGS AND PRECAUTIONS Respiratory depression: Increased risk in elderly, debilitated patients, and those suffering from conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve. ( 5.1 ) Misuse, abuse, and diversion: Oxymorphone Hydrochloride is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. ( 5.2 ) CNS effects: Additive CNS-depressive effects when used in conjunction with alcohol, other opioids, or illicit drugs. ( 5.3 ) Head injury: Effects may be markedly exaggerated. Administer with extreme caution. ( 5.4 ) Hypotensive effect: Increased risk with compromised ability to maintain blood pressure. Administer with caution to patients in circulatory shock. ( 5.5 ) Mild hepatic impairment: Use with caution and at lower doses due to higher plasma concentrations than in patients with normal hepatic function ( 5.6 ) Prolonged gastric obstruction: May occur in patients with gastrointestinal obstruction, especially paralytic ileus. ( 5.8 ) Sphincter of Oddi: Administer with caution in patients with biliary tract disease. ( 5.9 ) Impaired mental/physical abilities: Caution must be used with potentially hazardous activities. ( 5.10 ) 5.1 Respiratory Depression Respiratory depression is the chief hazard of oxymorphone hydrochloride. 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. Administer oxymorphone hydrochloride with extreme caution to patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, or coma. In these patients, even usual therapeutic doses of oxymorphone may decrease respiratory drive while simultaneously increasing airway resistance to the point of apnea. Consider alternative non-opioid analgesics and use oxymorphone hydrochloride only under careful medical supervision at the lowest effective dose in such patients. 5.2 Misuse, Abuse, and Diversion of Opioids Oxymorphone hydrochloride contains 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. Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This issue should be considered when prescribing or dispensing oxymorphone in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Oxymorphone hydrochloride tablets may be abused by crushing, chewing, snorting, or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death [see Drug Abuse and Dependence (9)] . Oxymorphone hydrochloride may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of this product, and security requirements for storing and handling of oxymorphone hydrochloride. Healthcare professionals should advise patients to store oxymorphone hydrochloride in a secure place, preferably locked and out of the reach of children and other noncaregivers. Concerns about abuse, misuse, diversion and addiction should not prevent the proper management of pain. 5.3 Additive CNS Depressant Effects 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 [see Drug Interactions (7.1)] . 5.4 Use in Patients with Head Injury and Increased Intracranial Pressure In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the respiratory depressant effects of opioid analgesics and their potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO 2 retention) may be markedly exaggerated. Furthermore, opioid analgesics can produce effects on papillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries. Administer oxymorphone hydrochloride with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted. 5.5 Hypotensive Effect Oxymorphone hydrochloride, like all opioid analgesics, 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 with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. 5.6 Hepatic Impairment A study of extended-release oxymorphone tablets in patients with hepatic disease indicated greater plasma concentrations than in those with normal hepatic function [see Clinical Pharmacology (12.3)] . Use oxymorphone hydrochloride with caution in patients with mild impairment, starting with the lowest dose and titrating slowly while carefully monitoring for side effects [see Dosage and Administration (2.2, 2.5)] . Oxymorphone hydrochloride is contraindicated in patients with moderate or severe hepatic impairment. 5.7 Special Risk Groups Use oxymorphone hydrochloride 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. 5.8 Gastrointestinal Effects Opioids diminish propulsive peristaltic waves in the gastrointestinal tract. Monitor for decreased bowel motility in post-operative patients receiving opioids. The administration of oxymorphone hydrochloride may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxymorphone hydrochloride is contraindicated in patients with paralytic ileus. 5.9 Use in Pancreatic/Biliary Tract Disease Oxymorphone hydrochloride, 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. 5.10 Driving and Operating Machinery Opioid analgesics impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.