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ROXICODONE® should be used with extreme caution in patients with significant chronic obstructive pulmonary disease and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression.

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ROXICODONE® may produce orthostatic hypotension in ambulatory patients. ROXICODONE®, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure. ROXICODONE® tablets are intended for use in patients who require oral pain therapy with an opioid agonist. As with any opioid analgesic, it is critical to adjust the dosing regimen individually for each patient ROXICODONE® (oxycodone hydrochloride) in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Health Care Policy and Research, and the American Pain Society. Use of ROXICODONE 15 mg is associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency  convulsive disorders; CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.

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