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warnings and cautions
5 WARNINGS AND PRECAUTIONS 5.1 Addiction, Abuse, and Misuse OXYCODONE HCl EXTENDED-RELEASE TABLETS contain oxycodone, a Schedule II controlled substance. As an opioid, OXYCODONE HCl EXTENDED-RELEASE TABLETS expose users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)]. As modified-release products such as OXYCODONE HCl EXTENDED-RELEASE TABLETS deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of oxycodone present [see Drug Abuse and Dependence (9)]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OXYCODONE HCl EXTENDED-RELEASE TABLETS. Addiction can occur at recommended doses and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse or misuse prior to prescribing OXYCODONE HCl EXTENDED-RELEASE TABLETS, and monitor all patients receiving OXYCODONE HCl EXTENDED-RELEASE TABLETS for the development of these behaviors or conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed modified-release opioid formulations such as OXYCODONE HCl EXTENDED-RELEASE TABLETS, but use in such patients necessitates intensive counseling about the risks and proper use of OXYCODONE HCl EXTENDED-RELEASE TABLETS along with intensive monitoring for signs of addiction, abuse, and misuse. Abuse, or misuse of OXYCODONE HCl EXTENDED-RELEASE TABLETS by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of oxycodone and can result in overdose and death [see Overdosage (10) ]. Opioid agonists are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing OXYCODONE HCl EXTENDED-RELEASE TABLETS. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug [see Patient Counseling Information (17)]. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 5.2 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of modified-release opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see Overdosage (10)]. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of OXYCODONE HCl EXTENDED-RELEASE TABLETS, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with OXYCODONE HCl EXTENDED-RELEASE TABLETS and following dose increases. To reduce the risk of respiratory depression, proper dosing and titration of OXYCODONE HCl EXTENDED-RELEASE TABLETS are essential [see Dosage and Administration (2)]. Overestimating the OXYCODONE HCl EXTENDED-RELEASE TABLETS dose when converting patients from another opioid product can result in a fatal overdose with the first dose. Accidental ingestion of even one dose of OXYCODONE HCl EXTENDED-RELEASE TABLETS, especially by children, can result in respiratory depression and death due to an overdose of oxycodone. 5.3 Neonatal Opioid Withdrawal Syndrome Prolonged use of OXYCODONE HCl EXTENDED-RELEASE TABLETS during pregnancy can result in withdrawal signs in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. 5.4 Interactions with Central Nervous System Depressants Hypotension and profound sedation, coma, or respiratory depression may result if OXYCODONE HCl EXTENDED-RELEASE TABLETS are used concomitantly with other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). When considering the use of OXYCODONE HCl EXTENDED-RELEASE TABLETS in a patient taking a CNS depressant, assess the duration of use of the CNS depressant and the patient’s response, including the degree of tolerance that has developed to CNS depression. Additionally, evaluate the patient’s use of alcohol or illicit drugs that can cause CNS depression. If the decision to begin OXYCODONE HCl EXTENDED-RELEASE TABLETS therapy is made, start with 1/3 to 1/2 the usual dose of OXYCODONE HCl EXTENDED-RELEASE TABLETS, monitor patients for signs of sedation and respiratory depression and consider using a lower dose of the concomitant CNS depressant [see Drug Interactions (7.1) and Dosage and Administration (2.6)]. 5.5 Use in Elderly, Cachectic, and Debilitated Patients Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients. Monitor such patients closely, particularly when initiating and titrating OXYCODONE HCl EXTENDED-RELEASE TABLETS and when OXYCODONE HCl EXTENDED-RELEASE TABLETS are given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.2)]. 5.6 Use in Patients with Chronic Pulmonary Disease Monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression for respiratory depression, particularly when initiating therapy and titrating with OXYCODONE HCl EXTENDED-RELEASE TABLETS, as in these patients, even usual therapeutic doses of OXYCODONE HCl EXTENDED-RELEASE TABLETS may decrease respiratory drive to the point of apnea [see Warnings and Precautions (5.2)]. Consider the use of alternative non-opioid analgesics in these patients if possible. 5.7 Hypotensive Effects OXYCODONE HCl EXTENDED-RELEASE TABLETS may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see Drug Interactions (7.1)]. Monitor these patients for signs of hypotension after initiating or titrating the dose of OXYCODONE HCl EXTENDED-RELEASE TABLETS. In patients with circulatory shock, OXYCODONE HCl EXTENDED-RELEASE TABLETS may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of OXYCODONE HCl EXTENDED-RELEASE TABLETS in patients with circulatory shock. 5.8 Use in Patients with Head Injury or Increased Intracranial Pressure Monitor patients taking OXYCODONE HCl EXTENDED-RELEASE TABLETS who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors) for signs of sedation and respiratory depression, particularly when initiating therapy with OXYCODONE HCl EXTENDED-RELEASE TABLETS. OXYCODONE HCl EXTENDED-RELEASE TABLETS may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of OXYCODONE HCl EXTENDED-RELEASE TABLETS in patients with impaired consciousness or coma. 5.9 Difficulty in Swallowing and Risk for Obstruction in Patients at Risk for a Small Gastrointestinal Lumen There have been post-marketing reports of difficulty in swallowing OXYCODONE HCl EXTENDED-RELEASE TABLETS. These reports included choking, gagging, regurgitation and tablets stuck in the throat. Instruct patients not to pre-soak, lick or otherwise wet OXYCODONE HCl EXTENDED-RELEASE TABLETS prior to placing in the mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth. There have been rare post-marketing reports of cases of intestinal obstruction, and exacerbation of diverticulitis, some of which have required medical intervention to remove the tablet. Patients with underlying GI disorders such as esophageal cancer or colon cancer with a small gastrointestinal lumen are at greater risk of developing these complications. Consider use of an alternative analgesic in patients who have difficulty swallowing and patients at risk for underlying GI disorders resulting in a small gastrointestinal lumen. 5.10 Use in Patients with Gastrointestinal Conditions OXYCODONE HCl EXTENDED-RELEASE TABLETS are contraindicated in patients with GI obstruction, including paralytic ileus. The oxycodone in OXYCODONE HCl EXTENDED-RELEASE TABLETS may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Opioids may cause increases in the serum amylase. 5.11 Use in Patients with Convulsive or Seizure Disorders The oxycodone in OXYCODONE HCl 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS therapy. 5.12 Avoidance of Withdrawal Avoid the use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including OXYCODONE HCl EXTENDED-RELEASE TABLETS. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. When discontinuing OXYCODONE HCl EXTENDED-RELEASE TABLETS, gradually taper the dose [see Dosage and Administration (2.9)]. Do not abruptly discontinue OXYCODONE HCl EXTENDED-RELEASE TABLETS. 5.13 Driving and Operating Machinery OXYCODONE HCl 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS and know how they will react to the medication. 5.14 Cytochrome P450 3A4 Inhibitors and Inducers Since the CYP3A4 isoenzyme plays a major role in the metabolism of OXYCODONE HCl EXTENDED-RELEASE TABLETS, drugs that alter CYP3A4 activity may cause changes in clearance of oxycodone which could lead to changes in oxycodone plasma concentrations. Inhibition of CYP3A4 activity by its inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of oxycodone and prolong opioid effects. CYP450 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone and, therefore, may cause increased clearance of the drug which could lead to a decrease in oxycodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone. If co-administration is necessary, caution is advised when initiating OXYCODONE HCl EXTENDED-RELEASE TABLETS treatment in patients currently taking, or discontinuing, CYP3A4 inhibitors or inducers. Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved [see Drug Interactions(7.2) and Clinical Pharmacology (12.3)]. 5.15 Laboratory Monitoring Not every urine drug test for “opioids” or “opiates” detects oxycodone reliably, especially those designed for in-office use. Further, many laboratories will report urine drug concentrations below a specified “cut-off” value as “negative”. Therefore, if urine testing for oxycodone is considered in the clinical management of an individual patient, ensure that the sensitivity and specificity of the assay is appropriate, and consider the limitations of the testing used when interpreting results.