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warnings and cautions
5 WARNINGS AND PRECAUTIONS 5.1 Addiction, Abuse, and Misuse HYCOFENIX contains hydrocodone, a Schedule II controlled substance. As an opioid, HYCOFENIX exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)], which can lead to overdose and death [see Overdosage (10)]. Reserve HYCOFENIX for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing HYCOFENIX, prescribe HYCOFENIX for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed HYCOFENIX. Addiction can occur at recommended dosages and if the drug is misused or abused. 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). Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing HYCOFENIX. 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, including hydrocodone, one of the active ingredients in HYCOFENIX. Hydrocodone produces dose-related respiratory depression by directly acting on the brain stem respiratory center that controls respiratory rhythm and may produce irregular and periodic breathing. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression includes discontinuation of HYCOFENIX, close observation, supportive measures, and use of opioid antagonists (e.g. naloxone), 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 HYCOFENIX, the risk is greatest during the initiation of therapy, when HYCOFENIX is used concomitantly with other drugs that may cause respiratory depression [see Warnings and Precautions (5.8)], in patients with chronic pulmonary disease or decreased respiratory reserve, and in patients with altered pharmacokinetics or altered clearance (e.g. elderly, cachectic, or debilitated patients) [see Warnings and Precautions (5.4)]. To reduce the risk of respiratory depression, proper dosing of HYCOFENIX is essential [see Dosage and Administration (2.1), Warnings and Precautions (5.5)]. Monitor patients closely, especially within the first 24-72 hours of initiating therapy or when used in patients at higher risk. Overdose of hydrocodone in adults has been associated with fatal respiratory depression, and the use of hydrocodone in children younger than 6 years of age has been associated with fatal respiratory depression when used as recommended. Accidental ingestion of even one dose of HYCOFENIX, especially by children, can result in respiratory depression and death. 5.3 Risks with Use in Pediatric Populations Children are particularly sensitive to the respiratory depressant effects of hydrocodone [see Warnings and Precautions (5.2)]. Because of the risk of life-threatening respiratory depression and death, HYCOFENIX is contraindicated in children less than 6 years of age [see Contraindications (4)]. Use of HYCOFENIX in children also exposes them to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)], which can lead to overdose and death [see Warnings and Precautions (5.1), Overdosage (10)]. Because the benefits of symptomatic treatment of cough associated with allergies or the common cold do not outweigh the risks of use of hydrocodone in pediatric patients, HYCOFENIX is not indicated for use in patients younger than 18 years of age [see Indications (1), Use in Specific Populations (8.4)]. 5.4 Risks with Use in Other At-Risk Populations Unresponsive Cough The dosage of HYCOFENIX should not be increased if cough fails to respond; an unresponsive cough should be reevaluated in 5 days or sooner for possible underlying pathology, such as foreign body or lower respiratory tract disease [see Dosage and Administration (2.3)]. Asthma and Other Pulmonary Disease The use of HYCOFENIX in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated [see Contraindications (4)]. Opioid analgesics and antitussives, including hydrocodone, one of the active ingredients in HYCOFENIX, should not be used in patients with acute febrile illness associated with productive cough or in patients with chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretions would have a deleterious effect on the patient’s respiratory function. HYCOFENIX-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 HYCOFENIX [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)]. Because of the risk of respiratory depression, avoid the use of opioid antitussives, including HYCOFENIX in patients with compromised respiratory function, patients at risk of respiratory failure, and in elderly, cachectic, or debilitated patients. If HYCOFENIX is prescribed, monitor such patients closely, particularly when initiating HYCOFENIX and when HYCOFENIX is given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.8)]. 5.5 Risk of Accidental Overdose and Death due to Medication Errors Dosing errors can result in accidental overdose and death. To reduce the risk of overdose and respiratory depression, ensure that the dose of HYCOFENIX is communicated clearly and dispensed accurately [see Dosage and Administration (2.1)]. Advise patients to always use an accurate milliliter measuring device when measuring and administering HYCOFENIX. Inform patients that household teaspoon is not an accurate measuring device and such use could lead to overdosage and serious adverse reactions [see Overdosage (10)]. For prescriptions where a measuring device is not provided, a pharmacist can provide an appropriate calibrated measuring device and can provide instructions for measuring the correct dose. 5.6 Activities Requiring Mental Alertness: Risks of Driving and Operating Machinery Hydrocodone, one of the active ingredients in HYCOFENIX, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of HYCOFENIX. Avoid concurrent use of HYCOFENIX with alcohol or other central nervous system depressants because additional impairment of central nervous system performance may occur [see Warnings and Precautions (5.8)]. 5.7 Risks from Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers Concomitant use of HYCOFENIX 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 HYCOFENIX is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in HYCOFENIX-treated patients may increase hydrocodone plasma concentrations and prolong opioid adverse reactions. Concomitant use of HYCOFENIX with CYP3A4 inducers or discontinuation of an 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. Avoid the use of HYCOFENIX in patients who are taking a CYP3A4 inhibitor or inducer. If concomitant use of HYCOFENIX with a CYP3A4 inhibitor or inducer is necessary, monitor patients for signs and symptoms that may reflect opioid toxicity and opioid withdrawal [see Drug Interactions (7.2, 7.3)]. 5.8 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants Concomitant use of opioids, including HYCOFENIX, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [see Drug Interactions (7.1, 7.4)]. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol. Advise both patients and caregivers about the risks of respiratory depression and sedation if HYCOFENIX is used with benzodiazepines, alcohol, or other CNS depressants [see Patient Counseling Information (17)]. Patients must not consume alcoholic beverages, or prescription or non-prescription products containing alcohol, while on HYCOFENIX therapy. The co-ingestion of alcohol with HYCOFENIX may result in increased plasma levels and a potentially fatal overdose of hydrocodone [see Drug Interactions (7.1, 7.4)]. 5.9 Risks of Use in Patients with Gastrointestinal Conditions HYCOFENIX is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Contraindications (4)]. The use of hydrocodone in HYCOFENIX may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of anticholinergics with HYCOFENIX may produce paralytic ileus [see Drug Interactions (7.9)]. The hydrocodone in HYCOFENIX may result in constipation or obstructive bowel disease, especially in patients with underlying intestinal motility disorders. Use with caution in patients with underlying intestinal motility disorders. The hydrocodone in HYCOFENIX may cause spasm of the sphincter of Oddi, resulting in an increase in biliary tract pressure. Opioids may cause increases in serum amylase [see Warnings and Precautions (5.16)]. Monitor patients with biliary tract disease, including acute pancreatitis for worsening symptoms. 5.10 Risks of Use in Patients with Head Injury, Impaired Consciousness, Increased Intracranial Pressure, or Brain Tumors Avoid the use of HYCOFENIX in patients with head injury, intracranial lesions, or a pre-existing increase in intracranial pressure. 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), HYCOFENIX may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries. 5.11 Cardiovascular and Central Nervous System Effects The pseudoephedrine contained in HYCOFENIX can produce cardiovascular and central nervous system effects in some patients such as, insomnia, dizziness, weakness, tremor, transient elevations in blood pressure, or arrhythmias. In addition, central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension has been reported. Therefore, HYCOFENIX is contraindicated in patients with severe hypertension or coronary artery disease [see Contraindications (4)], and should, be used with caution in patients with other cardiovascular disorders. 5.12 Increased Risk of Seizures in Patients with Seizure Disorders The hydrocodone in HYCOFENIX 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 HYCOFENIX therapy. 5.13 Severe Hypotension HYCOFENIX may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is 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 (7.4)]. Monitor these patients for signs of hypotension after initiating HYCOFENIX. In patients with circulatory shock, HYCOFENIX may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of HYCOFENIX in patients with circulatory shock. 5.14 Neonatal Opioid Withdrawal Syndrome HYCOFENIX is not recommended for use in pregnant women. Prolonged use of HYCOFENIX 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)] 5.15 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. 5.16 Drug/Laboratory Test Interactions Because opioid agonists may increase biliary tract pressure, with resultant increase in plasma amylase or lipase levels, determination of these enzyme levels may be unreliable for 24 hours after administration of a dose of HYCOFENIX. See Boxed WARNINGS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy. (5.4) Activities requiring mental alertness : Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. (5.6) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use. May increase intracranial pressure and obscure the clinical course of head injuries. (5.10) Cardiovascular and central nervous system effects : Use with caution in patients with cardiovascular disorders. (5.11) Seizures in patients with seizure disorders : Monitor during therapy. (5.12) Severe hypotension : Monitor during initiation of therapy. Avoid use in patients with circulatory shock. (5.13) Adrenal insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.15) 5.1 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants Concomitant use of opioids, including HYCOFENIX, with benzodiazepines, or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Because of these risks, avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol [ see Drug Interactions ( 7.1 ) ]. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. Because of similar pharmacologic properties, it is reasonable to expect similar risk with concomitant use of opioid cough medications and benzodiazepines, other CNS depressants, or alcohol. Advise both patients and caregivers about the risks of respiratory depression and sedation if HYCOFENIX is used with benzodiazepines, alcohol, or other CNS depressants [ see Patient Counseling Information ( 17 ) ]. 5.2 Respiratory Depression Hydrocodone bitartrate, one of the active ingredients in HYCOFENIX, produces doserelated respiratory depression by directly acting on brain stem respiratory centers. Overdose of hydrocodone bitartrate in adults has been associated with fatal respiratory depression, and the use of hydrocodone bitartrate in children less than 6 years of age has been associated with fatal respiratory depression. Exercise caution when administering HYCOFENIX because of the potential for respiratory depression. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated [ see Overdosage ( 10 ) ]. 5.3 Drug Dependence Hydrocodone can produce drug dependence of the morphine type and therefore, has the potential for being abused. Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of HYCOFENIX. Prescribe and administer HYCOFENIX with the same degree of caution appropriate to the use of other opioid drugs [ see Drug Abuse and Dependence ( 9.2 ), ( 9.3 ) ]. 5.4 Head Injury and Increased Intracranial Pressure The respiratory depression effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of HYCOFENIX should be avoided in these patients. 5.5 Activities Requiring Mental Alertness Hydrocodone bitartrate, one of the active ingredients in HYCOFENIX, may produce marked drowsiness and impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Advise patients to avoid engaging in hazardous tasks requiring mental alertness and motor coordination after ingestion of HYCOFENIX. Concurrent use of HYCOFENIX with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur. 5.6 Acute Abdominal Conditions HYCOFENIX should be used with caution in patients with acute abdominal conditions since the administration of hydrocodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions. The concurrent use of other anticholinergics with hydrocodone may produce paralytic ileus [ see Drug Interactions ( 7.3 ) ]. 5.7 Co-administration with Anticholinergics The concurrent use of anticholinergics with hydrocodone may produce paralytic ileus. Exercise caution when using HYCOFENIX in patients taking anticholinergic medications [ see Drug Interactions ( 7.3 ) ]. 5.8 Co-administration with Monoamine Oxidase Inhibitors (MAOIs) or Tricyclic Antidepressants HYCOFENIX should not be used in patients receiving MAOI therapy or within 14 days of stopping such therapy. The use of MAOIs or tricyclic antidepressants with hydrocodone bitartrate may increase the effect of either the antidepressant or hydrocodone [ see Contraindications ( 4 ) and Drug Interactions ( 7.2 ) ]. 5.9 Cardiovascular and Central Nervous System Effects The pseudoephedrine hydrochloride contained in HYCOFENIX can produce cardiovascular and central nervous system effects in some patients such as insomnia, dizziness, weakness, tremor, or arrhythmias. In addition, central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension has been reported. Therefore, HYCOFENIX should be used with caution in patients with cardiovascular disorders, and should not be used in patients with severe hypertension or coronary artery disease. 5.10 Persistent Cough HYCOFENIX should not be used in patients with a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus). 5.11 Dosing Patients should be advised to measure HYCOFENIX with an accurate milliliter measuring device. Patients should be informed that a household teaspoon is not an accurate measuring device and could lead to overdosage, which can result in serious adverse reactions [ see Overdosage ( 10 ) ]. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose. 5.12 Coexisting Conditions HYCOFENIX should be used with caution in patients with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy or urethral stricture, and asthma. 5.13 Renal Impairment HYCOFENIX should be used with caution in patients with severe renal impairment [ see Use in Specific Populations ( 8.6 ) ]. 5.14 Hepatic Impairment HYCOFENIX should be used with caution in patients with severe hepatic impairment [ see Use in Specific Populations ( 8.7 ) ].