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warnings and cautions
5 WARNINGS AND PRECAUTIONS Must be swallowed whole (5.1) May cause somnolence, dizziness, alterations in judgment and alterations in levels of consciousness, including coma. (5.2) Additive CNS effects are expected when used with alcohol, other opioids, or illicit drugs. (5.1 , 5.3, 7.3) Use with caution in patients who are receiving other CNS depressants. (5.1 , 5.3, 7.3) May cause respiratory depression, use with extreme caution in patients at risk of respiratory depression, elderly and debilitated patients (5.4) May aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. (5.5) May worsen increased intracranial pressure and obscure its signs, such as level of consciousness or pupillary signs. (5.6) May cause hypotension, use with caution in patients at increased risk of hypotension and in patients in circulatory shock. (5.7) Concomitant use of CYP3A4 inhibitors may increase opioid effects (5.8) Mixed agonist/antagonist analgesics may precipitate withdrawal symptoms. (5.9) Use with caution in patients with biliary tract disease, including acute pancreatitis. (5.10) Use with caution in patients at risk for ileus. Monitor for decreased bowel motility in postoperative patients. (5.10) Tolerance may develop. (5.11) Use with caution in alcoholism; adrenocortical insufficiency; hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis. (5.12) May impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. (5.13) No approved use in the treatment of addiction. (5.14) Not every urine drug test for "opioids" or "opiates" detects oxycodone reliably. (5.15) 5.1 Information Essential for Safe Administration OxyContin tablets must be swallowed whole and must not be cut, broken, chewed, crushed, or dissolved. Taking cut, broken, chewed, crushed or dissolved OxyContin tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone. OxyContin 60 mg and 80 mg Tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in opioid-tolerant patients . Use of these doses in patients who are not opioid tolerant may cause fatal respiratory depression. Instruct patients against use by individuals other than the patient for whom OxyContin was prescribed, as such inappropriate use may have severe medical consequences, including death. Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant 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. 5.2 CNS Depression OxyContin may cause somnolence, dizziness, alterations in judgment and alterations in levels of consciousness, including coma. 5.3 Interactions with Alcohol, CNS Depressants and Illicit Drugs Hypotension, profound sedation, coma or respiratory depression may result if OxyContin is added to a regimen that includes other CNS depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, other opioids). Therefore, use caution when deciding to initiate therapy with OxyContin in patients who are taking other CNS depressants. Take into account the types of other medications being taken, the duration of therapy with them, and the patient's response to those medicines, including the degree of tolerance that has developed to CNS depression. Consider the patient's use, if any, of alcohol and/or illicit drugs that cause CNS depression. If the decision to begin OxyContin is made, start with a lower OxyContin dose than usual. [see Drug Interactions (7.3) ] Consider using a lower initial dose of a CNS depressant when given to a patient currently taking OxyContin due to the potential of additive CNS depressant effects. 5.4 Respiratory Depression Decreased respiratory drive resulting in respiratory depression is the chief hazard from the use or abuse of opioid agonists, including OxyContin. The risk of opioid-induced respiratory depression is increased, for example, in elderly [see Use In Specific Populations (8.5) ] or debilitated patients; following large initial doses in any patient who is not tolerant to the respiratory-depressant or sedating effects of opioids; or when opioids are given in conjunction with other agents that either depress respiratory drive or consciousness. Use OxyContin with extreme caution in patients with any of the following: significant chronic obstructive pulmonary disease or cor pulmonale other risk of substantially decreased respiratory reserve hypoxia hypercapnia pre-existing respiratory depression Respiratory depression induced by opioids typically follows a pattern entailing first a shift in CO 2 responsiveness of the CNS respiratory drive center, which results in a decrease in the urge to breathe, despite the presence of hypercapnia. The increase in brain CO 2 can result in sedation that can accentuate the sedation from the opioid itself. Profound sedation, unresponsiveness, infrequent deep ("sighing") breaths or atypical snoring frequently accompany opioid-induced respiratory depression. Eventually, hypoxia ensues. In addition to further decreasing consciousness, hypoxia, along with hypercapnia, can predispose to life-threatening cardiac arrhythmias. 5.5 Seizures Oxycodone, as with other opioids, may aggravate convulsions in patients with convulsive disorders, and may induce or aggravate seizures in some clinical settings. Use OxyContin with caution in patients with a history of seizure disorders. 5.6 Head Injury The respiratory depressant effects of opioids include carbon dioxide retention, which can lead to an elevation of cerebrospinal fluid pressure. This effect may be exaggerated in the presence of head injury, intracranial lesions, or other sources of pre-existing increased intracranial pressure. Oxycodone may produce miosis that is independent of ambient light, and altered consciousness, either of which may obscure neurologic signs associated with increased intracranial pressure in persons with head injuries. 5.7 Hypotensive Effect OxyContin may cause severe hypotension. There is an added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. Oxycodone may produce orthostatic hypotension in ambulatory patients. Administer OxyContin with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure. 5.8 Cytochrome P450 3A4 Inhibitors and Inducers Since the CYP3A4 isoenzyme plays a major role in the metabolism of OxyContin, drugs that alter CYP3A4 activity may cause changes in clearance of oxycodone which could lead to changes in oxycodone plasma concentrations. The expected clinical results with CYP3A4 inhibitors would be an increase in oxycodone plasma concentrations and possibly increased or prolonged opioid effects. The expected clinical results with CYP3A4 inducers would be a decrease in oxycodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone. If co-administration is necessary, caution is advised when initiating OxyContin treatment in patients currently taking, or discontinuing, CYP3A4 inhibitors or inducers. Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved [see Drug Interactions (7.2) and Clinical Pharmacology (12) ] . 5.9 Interactions with Mixed Agonist/Antagonist Opioid Analgesics It is generally not advisable to administer mixed agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, and butorphanol) to a patient receiving OxyContin. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect and may precipitate withdrawal symptoms in these patients. 5.10 Use in Pancreatic/Biliary Tract Disease and Other Gastrointestinal Conditions Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids may cause increases in the serum amylase. The administration of OxyContin may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Use OxyContin with caution in patients who are at risk of developing ileus. 5.11 Tolerance Tolerance to opioids is demonstrated by the need for increasing doses to maintain adequate analgesic effect (in the absence of disease progression or other external factors). If tolerance develops, or if pain severity increases, a gradual increase in dose may be required. The first sign of tolerance is usually a reduced duration of effect. Tolerance to different effects of opioids may develop to varying degrees and at varying rates in a given individual. There is also inter-patient variability in the rate and extent of tolerance that develops to various opioid effects, whether the effect is desirable (e.g., analgesia) or undesirable (e.g., nausea). 5.12 Special Risk Groups Use OxyContin with caution in the following conditions, due to increased risk of adverse reactions: alcoholism; delirium tremens; adrenocortical insufficiency; CNS depression; debilitation; kyphoscoliosis associated with respiratory compromise; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis. 5.13 Driving and Operating Machinery OxyContin may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Caution patients accordingly. 5.14 Use in Addiction Treatment OxyContin has no approved use in the treatment of addiction. Its proper usage in individuals with drug or alcohol addiction (substance dependence), either active or in remission, is for the management of pain requiring opioid analgesia. 5.15 Laboratory Monitoring Not every urine drug test for "opioids" or "opiates" detects oxycodone reliably, especially those designed for in-office use. Further, many laboratories will report urine drug concentrations below a specified "cut-off" value as "negative". Therefore, if urine testing for oxycodone is considered in the clinical management of an individual patient, ensure that the sensitivity and specificity of the assay is appropriate, and use caution in interpreting results.