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warnings and cautions
5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Respiratory depression: Increased risk in elderly, debilitated patients, and those suffering from conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve. ( 5.2 ) Misuse, abuse, and diversion: OPANA ER is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. ( 5.3 ) CNS effects: Additive CNS-depressive effects when used in conjunction with alcohol, other opioids, or illicit drugs. ( 5.4 ) Head Injury: Effects may be markedly exaggerated. Administer OPANA ER with extreme caution. ( 5.5 ) Hypotensive effect: Increased risk with compromised ability to maintain blood pressure. Administer with caution to patients in circulatory shock. ( 5.6 ) Mild hepatic impairment: Use with caution and at lower doses due to higher plasma concentrations than in patients with normal hepatic function. ( 5.7 ) Prolonged gastric obstruction: May occur in patients with gastrointestinal obstruction. ( 5.9 ) Sphincter of Oddi: Administer with caution in patients with biliary tract disease. ( 5.11 ) Impaired mental/physical abilities: Caution must be used with potentially hazardous activities. ( 5.12 ) 5.1 Information Essential for Safe Administration OPANA ER tablets are to be swallowed whole, and are not to be cut, broken, chewed, crushed or dissolved. Taking cut, broken, chewed, dissolved, or crushed OPANA ER tablets could lead to the rapid release and absorption of a potentially fatal dose of oxymorphone [see Boxed Warning ] . Patients must not consume alcoholic beverages, or prescription or non-prescription medications containing alcohol, while on OPANA ER therapy. The co-ingestion of alcohol with OPANA ER may result in increased plasma levels and a potentially fatal overdose of oxymorphone [see Pharmacokinetics ( 12.3 )] . Instruct patients against use by individuals other than the patient for whom OPANA ER was prescribed, as such inappropriate use may have severe medical consequences, including death. 5.2 Respiratory Depression Respiratory depression is the chief hazard of OPANA ER. Respiratory depression is a potential problem 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 OPANA ER 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 OPANA ER only under careful medical supervision at the lowest effective dose in such patients. 5.3 Misuse, Abuse and Diversion of Opioids OPANA ER 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. OPANA ER tablets may be abused by crushing, chewing, snorting or injecting the product. These practices will result in the less controlled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death [see Drug Abuse and Dependence ( 9 )] . OPANA ER 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 OPANA ER. Healthcare professionals should advise patients to store OPANA ER in a secure place, preferably locked and out of the reach of children and other non-caregivers. Concerns about abuse, misuse, diversion and addiction should not prevent the proper management of pain. 5.4 Interactions with Alcohol and other CNS Depressants Patients receiving other opioid analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol) concomitantly with oxymorphone may experience respiratory depression, hypotension, profound sedation, coma and death [see Drug Interactions( 7.2 )] . Avoid concurrent use of alcohol and OPANA ER [see Pharmacokinetics ( 12.3 )] . 5.5 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 possible 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 OPANA ER with extreme caution to patients who may be particularly susceptible to the intracranial effects of CO 2 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. 5.6 Hypotensive Effect OPANA ER 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 OPANA ER with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. 5.7 Hepatic Impairment A study of oxymorphone hydrochloride extended-release tablets in patients with hepatic disease indicated greater plasma concentrations than those with normal hepatic function [see Clinical Pharmacology ( 12 )] . Use OPANA ER 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 ( 2.3 )] . OPANA ER is contraindicated in patients with moderate or severe hepatic impairment. 5.8 Special Risk Groups Use OPANA ER 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. 5.9 Gastrointestinal Effects OPANA ER decreases bowel motility. Opioids diminish propulsive peristaltic waves in the gastrointestinal tract. Monitor for decreased bowel motility in post-operative patients receiving opioids. The administration of OPANA ER may obscure the diagnosis or clinical course in patients with acute abdominal conditions. OPANA ER is contraindicated in patients with paralytic ileus. 5.10 Ambulatory Surgery and Post-Operative Use OPANA ER is not indicated for pre-emptive analgesia (administration pre-operatively for the management of post-operative pain). OPANA ER is only indicated for postoperative use in the patient if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate (see American Pain Society Guidelines). Patients who are already receiving OPANA ER as part of ongoing analgesic therapy may be safely continued on the drug if appropriate dosage adjustments are made considering the procedure, other drugs given, and the temporary changes in physiology caused by the surgical intervention. 5.11 Use in Pancreatic/Biliary Tract Disease OPANA ER, 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. 5.12 Driving and Operating Machinery Opioid analgesics, including OPANA ER, may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.