OXYCODONE HCl (Page 5 of 12)

5.7 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

The use of OXYCODONE HCl EXTENDED-RELEASE TABLETS in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
Patients with Chronic Pulmonary Disease: OXYCODONE HCl EXTENDED-RELEASE TABLETS-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of OXYCODONE HCl EXTENDED-RELEASE TABLETS [ see Warnings and Precautions ( 5.3) ].
Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [ see Warnings and Precautions ( 5.3) ].
Monitor such patients closely, particularly when initiating and titrating OXYCODONE HCl EXTENDED-RELEASE TABLETS and when OXYCODONE HCl EXTENDED-RELEASE TABLETS are given concomitantly with other drugs that depress respiration [ see Warnings and Precautions ( 5.3, 5.6) ]. Alternatively, consider the use of non-opioid analgesics in these patients.

5.8 Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

5.9 Severe Hypotension

OXYCODONE HCl EXTENDED-RELEASE TABLETS may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [ see Drug Interactions ( 7) ]. Monitor these patients for signs of hypotension after initiating or titrating the dosage of OXYCODONE HCl EXTENDED-RELEASE TABLETS. In patients with circulatory shock, OXYCODONE HCl EXTENDED-RELEASE TABLETS may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of OXYCODONE HCl EXTENDED-RELEASE TABLETS in patients with circulatory shock.

5.10 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

In patients who may be susceptible to the intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), OXYCODONE HCl EXTENDED-RELEASE TABLETS may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with OXYCODONE HCl EXTENDED-RELEASE TABLETS.
Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of OXYCODONE HCl EXTENDED-RELEASE TABLETS in patients with impaired consciousness or coma.

5.11 Difficulty in Swallowing and Risk for Obstruction in Patients at Risk for a Small Gastrointestinal Lumen

There have been post-marketing reports of difficulty in swallowing OXYCODONE HCl EXTENDED-RELEASE TABLETS. These reports included choking, gagging, regurgitation and tablets stuck in the throat. Instruct patients not to pre-soak, lick, or otherwise wet OXYCODONE HCl EXTENDED-RELEASE TABLETS prior to placing in the mouth, and to take one tablet at a time with enough water to ensure complete swallowing immediately after placing in the mouth.
There have been rare post-marketing reports of cases of intestinal obstruction, and exacerbation of diverticulitis, some of which have required medical intervention to remove the tablet. Patients with underlying GI disorders such as esophageal cancer or colon cancer with a small gastrointestinal lumen are at greater risk of developing these complications. Consider use of an alternative analgesic in patients who have difficulty swallowing and patients at risk for underlying GI disorders resulting in a small gastrointestinal lumen.

5.12 Risks of Use in Patients with Gastrointestinal Conditions

OXYCODONE HCl EXTENDED-RELEASE TABLETS are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.
The oxycodone in OXYCODONE HCl EXTENDED-RELEASE TABLETS may cause spasm of the sphincter of Oddi. Opioids may cause increases in the serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

5.13 Increased Risk of Seizures in Patients with Seizure Disorders

The oxycodone in OXYCODONE HCl EXTENDED-RELEASE TABLETS may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during OXYCODONE HCl EXTENDED-RELEASE TABLETS therapy.

5.14 Withdrawal

Do not abruptly discontinue OXYCODONE HCl EXTENDED-RELEASE TABLETS in a patient physically dependent on opioids. When discontinuing OXYCODONE HCl EXTENDED-RELEASE TABLETS in a physically dependent patient, gradually taper the dosage. Rapid tapering of oxycodone in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain [see Dosage and Administration ( 2.9), Drug Abuse and Dependence ( 9.3)]. Additionally, avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including OXYCODONE HCl EXTENDED-RELEASE TABLETS. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or may precipitate withdrawal symptoms.

5.15 Risks of Driving and Operating Machinery

OXYCODONE HCl EXTENDED-RELEASE TABLETS may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of OXYCODONE HCl EXTENDED-RELEASE TABLETS and know how they will react to the medication [ see Patient Counseling Information ( 17) ].

5.16 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 consider the limitations of the testing used when interpreting results.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

  • Addiction, Abuse, and Misuse [ see Warnings and Precautions ( 5.1) ]
  • Life-Threatening Respiratory Depression [ see Warnings and Precautions ( 5.3) ]
  • Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions ( 5.4) ]
  • Interactions With Benzodiazepines and Other CNS Depressants [ see Warnings and Precautions ( 5.6) ]
  • Adrenal Insufficiency [ see Warnings and Precautions ( 5.8) ]
  • Severe Hypotension [ see Warnings and Precautions ( 5.9) ]
  • Gastrointestinal Adverse Reactions [ see Warnings and Precautions ( 5.11, 5.12) ]
  • Seizures [ see Warnings and Precautions ( 5.13) ]
  • Withdrawal [ see Warnings and Precautions ( 5.14) ]

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