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warnings
WARNINGS May be habit forming. Hydrocodone can product 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 this product 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 section). Respiratory Depressions: This product produces dose-related respiratory depression by directly acting on the brain stem respiratory centers. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing. If respiratory depression occurs, it may be antagonized by the use of naloxone and other supportive measures when indicated. Head Injury and Increased Intracranial Pressure: The respiratory depressant properties of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracrainial 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 this product or other opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
ADVERSE REACTIONS Adverse reactions include drowsiness, lassitude, nausea, giddiness, constipation, respiratory depression and addiction. The most frequently observed adverse reactions include light-headedness, dizziness, drowsiness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions my be alleviated if the patient lies down Respiratory System: Hydrocodone produces dose-related respiratory depression by acting directly on brain stem respiratory centers. Cardiovascular System: Hypertension, postural hypotension 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.