May cause CNS depression. Use with caution in history of drug abuse or acute alcoholism (potential for drug dependency). Tolerance, psychological and physical dependence may occur with prolonged use. Use with extreme caution in head injury, intracranial lesions, or elevated intracranial pressure (exaggerated elevation of intracranial pressure may occur). May cause hypotension (caution in hypovolemia, cardiovascular disease, or drugs which may exaggerate hypotensive effects as phenothiazines or general anesthetics). Use with caution in hypersensitivity reactions to other phenanthrene-derivative opioid agonists (hydrocodone, hydromorphone, levorphanol, oxycodone, oxymorphone). May interfere with diagnosis or clinical course of acute abdominal conditions. Use with caution in adrenal insufficiency, including Addison’s disease. Use with caution in biliary tract dysfunction (acute pancreatitis may cause constriction of sphincter of Oddi). Use with caution in prostatic hyperplasia and/or urinary stricture. Use with caution in severe hepatic/renal impairment. Use with caution in morbidly obese patients. Use with caution in pre-existing respiratory compromise (hypoxia and/or hypercapnia), and kyphoscoliosis or other skeletal disorders which may alter respiratory function (critical respiratory depression may occur). Use with caution in thyroid dysfunction. Effects may be potentiated when used with other sedative drugs or ethanol. Use caution in patients with two or more copies of the variant CYP2D6*2 (may enhance conversion to morphine and thus increased opioid-mediated effects). Use with caution in debilitated patients (greater potential for critical respiratory depression). Use with caution in the elderly (may be more sensitive to adverse effects). Some preparations contain sulfites which may cause allergic reactions. Not recommended for use for cough control in productive cough. Not approved for I.V. administration. Concurrent use of agonist/antagonist analgesics may precipitate withdrawal symptoms and/or reduced analgesic efficacy following prolonged therapy with μ-opioid agonists. Abrupt discontinuation following prolonged use may also lead to withdrawal symptoms.