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warnings and cautions
5 WARNINGS AND PRECAUTIONS 5.1 Addiction, Abuse, and Misuse OXYCODONE HCl EXTENDED-RELEASE TABLETS contains oxycodone, a Schedule II controlled substance. As an opioid, OXYCODONE HCl EXTENDED-RELEASE TABLETS expose users to the risks of addiction, abuse, and misuse. Because extended-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 and 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 opioids 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)]. Opioids 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 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 dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of OXYCODONE HCl EXTENDED-RELEASE TABLETS. 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 dosage 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 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. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Use in Specific Populations (8.1), Patient Counseling Information (17)]. 5.4 Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers Concomitant use of OXYCODONE HCl EXTENDED-RELEASE TABLETS with a CYP3A4 inhibitor, 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 adverse reactions, which may cause potentially fatal respiratory depression [see Warnings and Precautions (5.2)], particularly when an inhibitor is added after a stable dose of OXYCODONE HCl EXTENDED-RELEASE TABLETS is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in OXYCODONE HCl EXTENDED-RELEASE TABLETS -treated patients may increase oxycodone plasma concentrations and prolong opioid adverse reactions. When using OXYCODONE HCl EXTENDED-RELEASE TABLETS with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in OXYCODONE HCl EXTENDED-RELEASE TABLETS -treated patients, monitor patients closely at frequent intervals and consider dosage reduction of OXYCODONE HCl EXTENDED-RELEASE TABLETS until stable drug effects are achieved [see Drug Interactions (7)]. Concomitant use of OXYCODONE HCl EXTENDED-RELEASE TABLETS with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease oxycodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to oxycodone. When using OXYCODONE HCl EXTENDED-RELEASE TABLETS with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur [see Drug Interactions (7)]. 5.5 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Profound sedation, respiratory depression, coma, and death may result if OXYCODONE HCl EXTENDED-RELEASE TABLETS are used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., non-benzodiazepines sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions (7)]. If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when OXYCODONE HCl EXTENDED-RELEASE TABLETS is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions (7), Patient Counseling Information (17)]. 5.6 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of OXYCODONE HCl EXTENDED-RELEASE TABLETS in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated. Patients with Chronic Pulmonary Disease: OXYCODONE HCl EXTENDED-RELEASE TABLETS -treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of OXYCODONE HCl EXTENDED-RELEASE TABLETS [see Warnings and Precautions (5.2)]. Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions (5.2)]. 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, 5.5)]. Alternatively, consider the use of non-opioid analgesics in these patients. 5.7 Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency. 5.8 Severe Hypotension 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)]. Monitor these patients for signs of hypotension after initiating or titrating the dosage 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. 5.9 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), OXYCODONE HCl EXTENDED-RELEASE TABLETS may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with OXYCODONE HCl EXTENDED-RELEASE TABLETS. 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. 5.10 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. 5.11 Risks of Use in Patients with Gastrointestinal Conditions OXYCODONE HCl EXTENDED-RELEASE TABLETS are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. The oxycodone in OXYCODONE HCl EXTENDED-RELEASE TABLETS may cause spasm of the sphincter of Oddi. Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. 5.12 Increased Risk of Seizures in Patients with Seizure Disorders The oxycodone in OXYCODONE HCl EXTENDED-RELEASE TABLETS may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during OXYCODONE HCl EXTENDED-RELEASE TABLETS therapy. 5.13 Withdrawal Avoid the use of mixed agonist/antagonist (e.g.., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving 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 dosage [see Dosage and Administration (2.9)]. Do not abruptly discontinue OXYCODONE HCl EXTENDED-RELEASE TABLETS [see Drug Abuse and Dependence (9.3)]. 5.14 Risks of 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 [see Patient Counseling Information (17)]. 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.