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warnings
WARNINGS Respiratory Depression: As with all narcotics, HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension produces dose-related respiratory depression by directly acting on brain stem respiratory centers. Hydrocodone affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. Caution should be exercised when HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension is used postoperatively and in patients with pulmonary disease or whenever ventilatory function is depressed. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated (see OVERDOSAGE). Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics 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, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries. Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Obstructive Bowel Disease: Chronic use of narcotics may result in obstructive bowel disease especially in patients with underlying intestinal motility disorder. Pediatric Use: In pediatric patients, as well as adults, the respiratory center is sensitive to the depressant action of narcotic cough suppressants in a dose-dependent manner. Benefit to risk ratio should be carefully considered especially in pediatric patients with respiratory embarrassment (e.g., croup) (see PRECAUTIONS).
6 ADVERSE REACTIONS Central Nervous System: Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, euphoria, dizziness, psychic dependence, mood changes. Dermatologic System: Rash, pruritus. Gastrointestinal System: Nausea and vomiting may occur; they are more frequent in ambulatory than in recumbent patients. Prolonged administration of HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension may produce constipation. Genitourinary System: Ureteral spasm, spasm of vesicle sphincters and urinary retention have been reported with opiates. Respiratory Depression: HyTan (hydrocodone tannate and chlorpheniramine tannate) Suspension may produce dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE). Respiratory System: Dryness of the pharynx, occasional tightness of the chest.