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warnings and cautions
5 WARNINGS AND PRECAUTIONS 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) Seizures in patients with seizure disorders : Monitor during therapy. (5.11) Severe hypotension : Monitor during initiation of therapy. Avoid use in patients with circulatory shock. (5.12) Adrenal insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.14) 5.1 Addiction, Abuse, and Misuse 5.2 Life-Threatening Respiratory Depression 5.3 Risks with Use in Pediatric Populations 5.4 Risks with Use in Other At-Risk Populations 5.5 Risk of Accidental Overdose and Death due to Medication Errors Advise patients to always use an accurate milliliter measuring device when measuring and administering FLOWTUSS. 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 FLOWTUSS, 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 FLOWTUSS. Avoid concurrent use of FLOWTUSS 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 5.8 Risks from Concomitant Use with Benzodiazepines or other CNS Depressants Concomitant use of opioids, including FLOWTUSS, 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 FLOWTUSS is used with benzodiazepines, alcohol, or other CNS depressants [ see Patient Counseling Information (17) ] . 5.9 Risks of Use in Patients with Gastrointestinal Conditions FLOWTUSS 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). 5.10 Risks of Use in Patients with Head Injury, Impaired Consciousness, Increased Intracranial Pressure, or Brain Tumors Avoid the use of FLOWTUSS 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 CO 2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), FLOWTUSS may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure. Furthermore, opioids produce adverse reactions that may obscure the clinical course of patients with head injuries. 5.11 Increased Risk of Seizures in Patients with Seizure Disorders 5.12 Severe Hypotension 5.13 Neonatal Opioid Withdrawal Syndrome 5.14 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. 5.15 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 FLOWTUSS.