INDICATIONS AND USAGE
ROXICODONE (oxycodone HCl) tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve ROXICODONE for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):
- Have not been tolerated, or are not expected to be tolerated,
- Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
IMPORTANT SAFETY INFORMATION
|WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse
ROXICODONE expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing ROXICODONE, and monitor all patients regularly for the development of these behaviors and conditions.
Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to • complete a REMS-compliant education program, • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and • consider other tools to improve patient, household, and community safety.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of ROXICODONE. Monitor for respiratory depression, especially during initiation of ROXICODONE or following a dose increase.
Accidental ingestion of ROXICODONE, especially by children, can result in a fatal overdose of ROXICODONE.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of ROXICODONE during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Cytochrome P450 3A4 Interaction
The concomitant use of ROXICODONE with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving ROXICODONE and any CYP3A4 inhibitor or inducer.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
ROXICODONE is contraindicated in patients with:
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected gastrointestinal obstruction, including paralytic ileus
- Known hypersensitivity to oxycodone
WARNINGS AND PRECAUTIONS
- ROXICODONE contain oxycodone, a Schedule II controlled substance. As an opioid, ROXICODONE expose users to the risks of addiction, abuse, and misuse.
- Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing ROXICODONE, and monitor all patients receiving ROXICODONE for the development of these behaviors and conditions.
- To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers.
- Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Patients with chronic pulmonary disease, elderly, cachectic, or debilitated patients may be at increased risk. Monitor closely, especially during initiation and titration.
- 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.
- Accidental ingestion of even one dose of ROXICODONE, especially by children, can result in respiratory depression and death due to an overdose of ROXICODONE. Instruct patients to take steps to store ROXICODONE securely. Expired, unwanted, or unused ROXICODONE should be disposed of by flushing the unused medication down the toilet if a drug take-back option is not readily available.
- Neonatal opioid withdrawal syndrome (NOWS) may occur following prolonged use of opioids during pregnancy. Observe newborns for signs of NOWS and manage accordingly; NOWS may be life threatening if not recognized and treated in neonates.
- When using CYP3A4 inhibitors or discontinuing CYP3A4 inducers in ROXICODONE -treated patients, monitor patients closely at frequent intervals and consider dosage reduction of ROXICODONE until stable drug effects are achieved. When using ROXICODONE with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing the opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur.
- Profound sedation, respiratory depression, coma, and death may result from the concomitant use of ROXICODONE with benzodiazepines or other CNS depressants (including alcohol and illicit drugs).
- Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. If adrenal insufficiency is diagnosed, treat with physiologic replacement of corticosteroids and wean patient off of the opioid until adrenal function recovers.
- ROXICODONE may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Monitor during initiation and/or titration of ROXICODONE. Avoid use in patients with circulatory shock.
- Use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Use of ROXICODONE should be avoided in patients with impaired consciousness or coma.
- ROXICODONE is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. The oxycodone in ROXICODONE may cause spasm of the sphincter of Oddi.
- The oxycodone in ROXICODONE 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.
- Do not abruptly discontinue ROXICODONE in a patient physically dependent on opioids. When discontinuing ROXICODONE 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.
- Avoid use of ROXICODONE with mixed agonist/antagonists or partial agonist analgesics due to risk of precipitation of withdrawal symptoms.
- Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of ROXICODONE and know how they will react to the medication.
- Opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop.
- The use of ROXICODONE is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
Serious adverse reactions associated with ROXICODONE use include respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock. The most common adverse reactions include nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
This is not a complete list of potential adverse events associated with ROXICODONE. Please see Full Prescribing Information for a complete list.