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warnings and cautions
5 WARNINGS AND PRECAUTIONS Interactions with CNS depressants: Concomitant use may cause profound sedation, respiratory depression, and death. If coadministration is required, consider dose reduction of one or both drugs because of additive pharmacological effects. ( 5.4 , 7.2 ) Elderly, cachectic, debilitated patients, and those with chronic pulmonary disease: Monitor closely because of increased risk for life-threatening respiratory depression. ( 5.5 , 5.6 ) Hypotensive effect: Monitor during dose initiation and titration. ( 5.7 ) Patients with head injury or increased intracranial pressure: Monitor for sedation and respiratory depression. Avoid use of AVINZA in patients with impaired consciousness or coma susceptible to intracranial effects of CO 2 retention. ( 5.8 ) 5.1 Addiction, Abuse, and Misuse AVINZA contains morphine, a Schedule II controlled substance. As an opioid, AVINZA exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9) ]. As modified-release products such as AVINZA deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of morphine present. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed AVINZA and in those who obtain the drug illicitly. 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 AVINZA, and monitor all patients receiving AVINZA 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 addiction or abuse) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the prescribing of AVINZA for the proper management of pain in any given patient. Patients at increased risk may be prescribed modified-release opioid formulations such as AVINZA, but use in such patients necessitates intensive counseling about the risks and proper use of AVINZA along with intensive monitoring for signs of addiction, abuse, and misuse. Abuse or misuse of AVINZA by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the morphine and can result in overdose and death [see Overdosage (10) ] . Opioid agonists such as AVINZA are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing AVINZA. 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 from opioid use, 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 (CO 2 ) 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 AVINZA, the risk is greatest during the initiation of therapy or following a dose increase. Closely monitor patients for respiratory depression when initiating therapy with AVINZA and following dose increases. To reduce the risk of respiratory depression, proper dosing and titration of AVINZA are essential [see Dosage and Administration (2) ] . Overestimating the AVINZA dose when converting patients from another opioid product can result in fatal overdose with the first dose. Accidental ingestion of even one dose of AVINZA, especially by children, can result in respiratory depression and death due to an overdose of morphine. 5.3 Neonatal Opioid Withdrawal Syndrome Prolonged use of AVINZA 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 Patients must not consume alcoholic beverages or prescription or non-prescription products containing alcohol while on AVINZA therapy. The co-ingestion of alcohol with AVINZA may result in increased plasma levels and a potentially fatal overdose of morphine [see Clinical Pharmacology (12.3) ] . Hypotension, profound sedation, coma, respiratory depression, and death may result if AVINZA is used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). When considering the use of AVINZA 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 cause CNS depression. If the decision to begin AVINZA is made, start with AVINZA 30 mg every 24 hours, monitor patients for signs of sedation and respiratory depression, and consider using a lower dose of the concomitant CNS depressant [see Drug Interactions (7.2) ] . 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 AVINZA and when AVINZA is 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 AVINZA, as in these patients, even usual therapeutic doses of AVINZA 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 Effect AVINZA 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 (7.2) ] . Monitor these patients for signs of hypotension after initiating or titrating the dose of AVINZA. In patients with circulatory shock, AVINZA may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of AVINZA in patients with circulatory shock. 5.8 Use in Patients with Head Injury or Increased Intracranial Pressure Monitor patients taking AVINZA who may be susceptible to the intracranial effects of CO 2 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 AVINZA. AVINZA may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure . Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of AVINZA in patients with impaired consciousness or coma. 5.9 Use in Patients with Gastrointestinal Conditions AVINZA is contraindicated in patients with paralytic ileus. Avoid the use of AVINZA in patients with other GI obstruction. The morphine in AVINZA 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. 5.10 Use in Patients with Convulsive or Seizure Disorders The morphine in AVINZA 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 AVINZA therapy. 5.11 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 opioid agonist analgesic, including AVINZA. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms. When discontinuing AVINZA, gradually taper the dose [see Dosage and Administration (2.3) ] . Do not abruptly discontinue AVINZA. 5.12 Driving and Operating Machinery AVINZA 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 AVINZA and know how they will react to the medication.