Oxymorphone Hydrochloride

Oxymorphone hydrochloride tablets are contraindicated in patients with:

• Significant respiratory depression [see Warnings and Precautions (
  
  
  5.2 Life-Threatening Respiratory Depression

  Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status [see Overdosage ]. Carbon dioxide (CO2) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

  While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of oxymorphone hydrochloride tablets, the risk is greatest during the initiation of therapy or following a dosage increase of oxymorphone hydrochloride tablets.

  To reduce the risk of respiratory depression, proper dosing and titration of oxymorphone hydrochloride tablets are essential [see Dosage and Administration ]. Overestimating the oxymorphone hydrochloride tablets dosage when converting patients from another opioid product can result in a fatal overdose with the first dose.

  Accidental ingestion of even one dose of oxymorphone hydrochloride tablets, especially by children, can result in respiratory depression and death due to an overdose of oxymorphone.

  Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Patient Counseling Information ].

  Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see Dosage and Administration ].

  Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose

  Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver and assess the potential need for access to naloxone, both when initiating and renewing treatment with oxymorphone hydrochloride tablets. Inform patients and caregivers about the various ways to obtain naloxone as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program). Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help, even if naloxone is administered [see Patient Counseling Information (17)].

  Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose. The presence of risk factors for overdose should not prevent the proper management of pain in any given patient. Also consider prescribing naloxone if the patient has household members (including children) or other close contacts at risk for accidental ingestion or overdose. If naloxone is prescribed, educate patients and caregivers on how to treat with naloxone [see Warnings and Precautions (5.1, 5.3), Patient Counseling Information (17), Overdosage (10)].
  )]
  
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  
  
  [see Warnings and Precautions (
  5.7 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

  The use of oxymorphone hydrochloride 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:

  Oxymorphone hydrochloride 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 oxymorphone hydrochloride tablets

  [see Warnings and Precautions (

  5.2

  )].

  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 ].

  Regularly evaluate patients, particularly when initiating and titrating oxymorphone hydrochloride tablets and when oxymorphone hydrochloride tablets are given concomitantly with other drugs that depress respiration

  [see Use in Specific Populations (8.5)].

  Alternatively, consider the use of non-opioid analgesics in these patients.
  )]
• Known or suspected gastrointestinal obstruction, including paralytic ileus
  
  
  [see Warnings and Precautions (
  5.12 Risks of Use in Patients with Gastrointestinal Conditions

  Oxymorphone hydrochloride tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.

  The oxymorphone in oxymorphone hydrochloride tablets may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Regularly evaluate patients with biliary tract disease, including acute pancreatitis for worsening symptoms.
  )]
• Hypersensitivity to oxymorphone (e.g., anaphylaxis, angioedema) or
  
  
  [see Warnings and precautions (
  5.8 Anaphylaxis, Angioedema, and Other Hypersensitivity Reactions

  Potentially life-threatening hypersensitivity reactions, including anaphylaxis and angioedema, have occurred in patients treated with oxymorphone hydrochloride tablets in the postmarket setting. The most commonly described clinical features in these reports were swelling of the face, eyes, mouth, lips, tongue, hands, and/or throat; dyspnea; hives, pruritus, and/or rash; and nausea/vomiting. If anaphylaxis or other hypersensitivity occurs, stop administration of oxymorphone hydrochloride tablets immediately, discontinue oxymorphone hydrochloride tablets permanently, and do not rechallenge with any formulation of oxymorphone. Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction

  [see Patient Counseling Information ].
  ), Adverse Reactions (
  
  6)]
  
  
• Moderate or severe hepatic impairment
  
  
  [see Warnings and Precautions (
  5.16 Hepatic Impairment

  A study of extended-release oxymorphone tablets in patients with hepatic disease indicated greater plasma concentrations than in those with normal hepatic function

  [see Clinical Pharmacology ].

  Use oxymorphone hydrochloride tablets with caution in patients with mild impairment, starting with the lowest dose and titrating slowly while carefully monitoring for side effects

  [see Dosage and Administration ].

  Oxymorphone hydrochloride tablets are contraindicated in patients with moderate or severe hepatic impairment.
  )