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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease and in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. ( 5.7 ) • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.7 ) • Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of VANTRELA ER in patients with circulatory shock. ( 5.8 ) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use in patients with impaired consciousness or coma. ( 5.9 ) • QTc Prolongation: Consider this observation when making clinical decisions regarding monitoring of patients with congestive heart failure, bradyarrhythmias, or electrolyte abnormalities, or who are taking medications that are known to prolong the QTc interval. Avoid use in patients with congenital long QTc syndrome. In patients who develop QTc prolongation, consider reducing the dose. Do not exceed a dose of 90 mg every 12 hours (180 mg per day). Higher doses have not been studied. ( 5.14 , 12.2 ) 5.1 Addiction, Abuse and Misuse VANTRELA ER contains hydrocodone, a Schedule II controlled substance. As an opioid, VANTRELA ER exposes users to the risks of addiction, abuse, and misuse. As extended-release products such as VANTRELA ER deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present [see Drug Abuse and Dependence ( 9 )] . Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed VANTRELA ER. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing VANTRELA ER, and monitor all patients receiving VANTRELA ER 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 proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as VANTRELA ER, but use in such patients necessitates intensive counseling about the risks and proper use of VANTRELA ER along with intensive monitoring for signs of addiction, abuse, and misuse. Abuse or misuse of VANTRELA ER by crushing, chewing, snorting, or injecting the dissolved product will result in the uncontrolled delivery of the hydrocodone 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 VANTRELA ER. 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 (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 VANTRELA ER, the risk is greatest during the initiation of therapy or following a dosage increase. Closely monitor patients for respiratory depression when initiating therapy with and following dosage increases of VANTRELA ER. To reduce the risk of respiratory depression, proper dosing and titration of VANTRELA ER are essential [see Dosage and Administration ( 2 )] . Overestimating the VANTRELA ER dosage when converting patients from another opioid product, can result in fatal overdose with the first dose. Accidental ingestion of even one dose of VANTRELA ER, especially by children, can result in respiratory depression and death due to an overdose of hydrocodone. 5.3 Neonatal Opioid Withdrawal Syndrome Prolonged use of VANTRELA ER 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. 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 VANTRELA ER 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 hydrocodone 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 VANTRELA ER is achieved . Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in VANTRELA ER-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions. When using VANTRELA ER with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in VANTRELA ER-treated patients, monitor patients closely at frequent intervals and consider dosage reduction of VANTRELA ER until stable drug effects are achieved [see Drug Interactions ( 7 )]. Concomitant use of VANTRELA ER with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease hydrocodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to hydrocodone. When using VANTRELA ER 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 from the concomitant use of VANTRELA ER with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine 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 VANTRELA ER 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 and in Elderly, Cachectic, or Debilitated Patients The use of VANTRELA ER 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 : VANTRELA ER -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 VANTRELA ER [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 VANTRELA ER and when VANTRELA ER is 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 VANTRELA ER may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume or concurrent administration of certain CNS depressants (e.g., phenothiazines or general anesthetics) [see Drug Interactions ( 7 )] . Monitor these patients for signs of hypotension after initiating or titrating the dosage of VANTRELA ER. In patients with circulatory shock, VANTRELA ER may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of VANTRELA ER 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 CO 2 retention (e.g., those with evidence of increased intracranial pressure as can be caused by certain brain tumors), VANTRELA ER may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with VANTRELA ER. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of VANTRELA ER in patients with impaired consciousness or coma. 5.10 Risks of Use in Patients with Gastrointestinal Conditions VANTRELA ER is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. The hydrocodone in VANTRELA ER may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. 5.11 Increased Risk of Seizures in Patients with Seizure Disorders The hydrocodone in VANTRELA ER 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 VANTRELA ER therapy. 5.12 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 course of therapy with a full opioid agonist analgesic, including VANTRELA ER. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms [see Drug Interactions ( 7 )] . When discontinuing VANTRELA ER, gradually taper the dosage [see Dosage and Administration ( 2.6 )] . Do not abruptly discontinue VANTRELA ER [see Drug Abuse and Dependence ( 9.3 )]. 5.13 Risks of Driving and Operating Machinery VANTRELA ER may impair the mental and 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 VANTRELA ER and know how they will react to the medication. 5.14 Risk of QTc Interval Prolongation QTc prolongation has been observed with VANTRELA ER [see Clinical Pharmacology ( 12.2 )] . Consider this observation when making clinical decisions regarding monitoring of patients with congestive heart failure, bradyarrhythmias, or electrolyte abnormalities, or who are taking medications that are known to prolong the QTc interval. Avoid use of VANTRELA ER in patients with congenital long QT syndrome. In patients who develop QTc prolongation, consider changing to an alternate analgesic. Do not exceed a dose of 90 mg every 12 hours (180 mg per day). Higher doses have not been studied.