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. ( 5.11 ) 5.1 Respiratory Depression Hydrocodone bitartrate, one of the active ingredients in HYCOFENIX, produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Overdose of hydrocodone bitartrate 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 ) ]. 5.2 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 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 ) ]. 5.3 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 HYCOFENIX should be avoided in these patients. 5.4 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. 5.5 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 ) ]. 5.6 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 ) ]. 5.7 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 ) ]. 5.8 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. 5.9 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). 5.10 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 Ooverdosage ( 10 ) ]. Patients should be advised to ask their pharmacist to recommend an appropriate measuring device and for instructions for measuring the correct dose. 5.11 Coexisting Conditions HYCOFENIX should be used with caution in patients with diabetes, thyroid disease, Addison's disease, prostatic hypertrophy or urethral stricture, and asthma. 5.12 Renal Impairment HYCOFENIX should be used with caution in patients with severe renal impairment [ see Use in Specific Populations ( 8.6 ) ]. 5.13 Hepatic Impairment HYCOFENIX should be used with caution in patients with severe hepatic impairment [ see Use in Specific Populations ( 8.7 ) ].