warnings and cautions
5 WARNINGS AND PRECAUTIONS • Dose-related respiratory depression: Use with caution. ( 5.1 ) • Drug Dependence: Prescribe with caution that is appropriate to the use of other opioids. ( 5.2 ) • Head injury and increased intracranial pressure: Avoid in patients with head injury, intracranial lesions or increased intracranial pressure. ( 5.3 ) • Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating machinery. ( 5.4 ) • Acute abdominal conditions: Use with caution in patients with acute abdominal conditions. ( 5.5 ) • Coexisting conditions: Use with caution in patients with diabetes, thyroid disease, Addison’s disease, prostatic hypertrophy, or urethral stricture, or asthma. ( 5.10 ) 5.1 Respiratory Depression Hydrocodone bitartrate, one of the active ingredients in FLOWTUSS, produces dose-related 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 FLOWTUSS 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 ) ]. 5.2 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 FLOWTUSS. Prescribe and administer FLOWTUSS with the same degree of caution appropriate to the use of other opioid drugs [ see Drug Abuse and Dependence ( 9.2 ), ( 9.3 ) ]. 5.3 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 FLOWTUSS should be avoided in these patients. 5.4 Activities Requiring Mental Alertness Hydrocodone bitartrate, 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. Concurrent use of FLOWTUSS with alcohol or other central nervous system depressants should be avoided because additional impairment of central nervous system performance may occur. 5.5 Acute Abdominal Conditions FLOWTUSS 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 ) ]. 5.6 Co-administration with Anticholinergics The concurrent use of anticholinergics with hydrocodone may produce paralytic ileus. Exercise caution when using FLOWTUSS in patients taking anticholinergic medications [ see Drug Interactions ( 7.3 ) ]. 5.7 Co-administration with Monoamine Oxidase Inihibitors (MAOIs) or Tricyclic Antidepressants FLOWTUSS should not be used in patients receiving monoamine oxidase inhibitor (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 ) ]. 5.8 Persistent Cough 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). 5.9 Dosing Patients should be advised to measure FLOWTUSS 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. 5.10 Coexisting Conditions FLOWTUSS should be used with caution in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, and asthma. 5.11 Renal Impairment FLOWTUSS should be used with caution in patients with severe renal impairment [ see Use in Specific Populations ( 8.6 ) ]. 5.12 Hepatic Impairment FLOWTUSS should be used with caution in patients with severe hepatic impairment [ see Use in Specific Populations ( 8.7 ) ].