A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience
Issue link: https://innovationscns.epubxp.com/i/895375
HOW COULD A PAIN TREATMENT AFFECT THE COMMUNITY? References: 1. Substance Abuse and Mental Health Services Administration (SAMHSA); US Department of Health and Human Services. Prescription Drug Use and Misuse in the United States: Results from the 2015 National Survey on Drug Use and Health. Published September 2016. 2. Data on file. Inflexxion data. Prescription opioid report: analysis for strategic planning, volume 1. Revision 1, January 17, 2012. 3. OXAYDO [package insert]. Wayne, PA: Egalet US Inc.; 2016. 4. Orange book: approved drug products with therapeutic equivalence evaluations. US Food and Drug Administration website. http://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. Updated January 2017. Accessed March 3, 2017. 5. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016;65(1):1-50. IMPORTANT SAFETY INFORMATION WARNING: ADDICTION, ABUSE, AND MISUSE; 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 OXAYDO ® (oxycodone HCl) tablets CII exposes 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 OXAYDO, and monitor all patients regularly for the development of these behaviors and conditions. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of OXAYDO. Monitor for respiratory depression, especially during initiation of OXAYDO or following a dose increase. Accidental Ingestion Accidental ingestion of even one dose of OXAYDO, especially by children, can result in a fatal overdose of oxycodone. Neonatal Opioid Withdrawal Syndrome Prolonged use of OXAYDO 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 OXAYDO 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 OXAYDO 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. • Reserve concomitant prescribing of OXAYDO and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. Please see additional Important Safety Information throughout and Full Prescribing Information at OXAYDO.com.