Intended for U.S. healthcare professionals only.
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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):
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:
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.
|Description||Green tablets scored|
|Generic Name||Oxycodone hydrochloride tablets USP|
|Dosage Strength||15 mg|
|Identification Code||Green tablet scored (identified 54 710) [Embossed 54 710 on one side]|
|NDC #||Package Size||Case Quantity|
|23635-581-10||Bottles of 100 Tablets||12 Bottles|
For additional information on Roxicodone™ (oxycodone hydrochloride) Tablets USP, CII 15 mg, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.
Revised January 2020