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warnings
WARNINGS May be habit forming. 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 HYCOMINE and it should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic drugs (See DRUG ABUSE AND DEPENDENCE ). Respiratory Depression HYCOMINE produces dose-related respiratory depression by directly acting on brain stem respiratory centers. If respiratory depression occurs, it may be antagonized by the use of naloxone hydrochloride and other supportive measures when indicated. Head Injury and Increased Intracranial Pressure The respiratory depression properties 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 preexisting 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 HYCOMINE or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Pediatric Use In young children, 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 children with respiratory embarrassment (e.g., croup). Phenylpropanolamine Hypertensive crises can occur with concurrent use of phenylpropanolamine and monoamine oxidase (MAO) inhibitors, indomethacin or with beta-blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. Fever should be managed by means of external cooling.
ADVERSE REACTIONS Respiratory System Hydrocodone produces dose-related respiratory depression by acting directly on brain stem respiratory centers (see OVERDOSAGE ). Cardiovascular System Hypertension, postural hypotension, tachycardia and palpitations. Genitourinary System Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates. Central Nervous System Sedation, drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, dizziness, psychic dependence, mood changes and blurred vision. Gastrointestinal System Nausea and vomiting occur more frequently in ambulatory than in recumbent patients. Prolonged administration of HYCOMINE may produce constipation. Dermatological Skin rash, pruritus.