Oxycodone hydrochloride 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 (see DOSAGE AND ADMINISTRATION).

Selection of patients for treatment with oxycodone hydrochloride tablets should be governed by the same principles that apply to the use of other potent opioid analgesics. Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension. Physicians should individualize treatment in every case, using nonopioid analgesics, prn opioids and /or combination products, and chronic opioid therapy with drugs such as oxycodone hydrochloride tablets 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 oxycodone hydrochloride tablets are associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison's disease); 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.

The administration of oxycodone hydrochloride tablets, like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Tolerance and Physical Dependence:

Physical dependence and tolerance are not unusual during chronic opioid therapy. Significant tolerance should not occur in most patients treated with the lowest doses of oxycodone. It should be expected, however, that a fraction of patients will develop some degree of tolerance and require progressively higher dosages of oxycodone hydrochloride tablets to maintain pain control during chronic treatment. The dosage should be selected according to the patient's individual analgesic response and ability to tolerate side effects. Tolerance to the analgesic effects of opioids is usually paralleled by tolerance to side effects except for constipation.

Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug or may be precipitated through the administration of drugs with opioid antagonist activity. If oxycodone hydrochloride tablets are abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur (see DRUG ABUSE AND DEPENDENCE). If signs and symptoms of withdrawal occur, patients should be treated by reinstitution of opioid therapy followed by gradual tapered dose reduction of oxycodone hydrochloride tablets combined with symptomatic support (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).

Use In Pancreatic/Bilary Tract Disease:

Oxycodone hydrochloride tablets may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone hydrochloride tablets may cause increases in the serum amylase level.

Information for Patients/Caregivers:

If clinically advisable, patients (or their caregivers) receiving oxycodone hydrochloride tablets should be given the following information by the physician, nurse, pharmacist or caregiver:

1\. Patients should be advised to report episodes of breakthrough pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.

2\. Patients should be advised not to adjust the dose of oxycodone hydrochloride tablets without consulting the prescribing professional.

3\. Patients should be advised that oxycodone hydrochloride tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g. driving, operating heavy machinery).

4\. Patients should not combine oxycodone hydrochloride tablets with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.

5\. Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.

6\. Patients should be advised that oxycodone hydrochloride tablet is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.

7\. Patients should be advised that if they have been receiving treatment with oxycodone hydrochloride tablets for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the oxycodone hydrochloride tablets dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.