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, intra-cranial 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 ) Avoid concurrent use of alcohol or other central nervous system depressants ( 5.4 ) Acute abdominal conditions: Use with caution in patients with acute abdominal conditions. ( 5.5 ) Coexisting conditions: Use with caution in patients with thyroid disease, Addison’s disease, prostatic hypertrophy, or urethral stricture, or asthma. ( 5.9 ) 5.1 Respiratory Depression Hydrocodone bitartrate, one of the active ingredients in hydrocodone bitartrate and chlorpheniramine maleate oral solution, 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 Hydrocodone bitartrate and chlorpheniramine maleate oral solution because of the potential for respiratory depression. If respiratory depression occurs, discontinue hydrocodone bitartrate and chlorpheniramine maleate oral solution and use naloxone hydrochloride when indicated to antagonize the effect and other supportive measures as necessary [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 hydrocodone bitartrate and chlorpheniramine maleate oral solution. Prescribe and administer hydrocodone bitartrate and chlorpheniramine maleate 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 preexisting increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries. The use of hydrocodone bitartrate and chlorpheniramine maleate oral solution should be avoided in these patients. 5.4 Activities Requiring Mental Alertness Hydrocodone bitartrate and chlorpheniramine maleate, the active ingredients in hydrocodone bitartrate and chlorpheniramine maleate oral solution, 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 hydrocodone bitartrate and chlorpheniramine maleate oral solution. Concurrent use of hydrocodone bitartrate and chlorpheniramine maleate oral solution 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 Hydrocodone bitartrate and chlorpheniramine maleate oral solution 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 hydrocodone bitartrate and chlorpheniramine maleate oral solution in patients taking anticholinergic medications [see Drug Interactions ( 7.3 ) ] . 5.7 Co-administration with MAOIs or Tricyclic Antidepressants Hydrocodone bitartrate and chlorpheniramine maleate oral solution 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, one of the active ingredients in hydrocodone bitartrate and chlorpheniramine maleate oral solution, may increase the effect of either the antidepressant or hydrocodone [ see Contraindications ( 4 ) and Drug Interactions ( 7.2 ) ]. 5.8 Dosing Patients should be advised to measure hydrocodone bitartrate and chlorpheniramine maleate oral solution 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. 5.9 Coexisting Conditions Hydrocodone bitartrate and chlorpheniramine maleate oral solution should be used with caution in patients with thyroid disease, Addison’s disease, prostatic hypertrophy, urethral stricture, or asthma. 5.10 Renal Impairment Hydrocodone bitartrate and chlorpheniramine maleate oral solution should be used with caution in patients with severe renal impairment [see Use in Specific Populations ( 8.6 ) ] . 5.11 Hepatic Impairment Hydrocodone bitartrate and chlorpheniramine maleate oral solution should be used with caution in patients with severe hepatic impairment [see Use in Specific Populations ( 8.7 ) ] .