Innovations In Clinical Neuroscience

Hot Topics in Pain Management October 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Snorting range=19.4% to 78.3%; injecting range=1.0% to 60.2%; smoking range=0.9% to 5.3%; oral range not reported. 2 Data were collected from January 2009 to September 2011. Data were obtained from the Addiction Severity Index–Multimedia Version (ASI-MV), a standardized computer, self-administered assessment that is part of the clinical flow for treatment planning and triage around substance abuse problems and associated life-functioning areas. The ASI-MV includes product-specific questions about past 30-day abuse of prescription medications. Data were derived from a sentinel, high-risk population of individuals being evaluated for substance abuse problems. Data for the study period included a total of 191,354 assessments collected from 637 sites located within 37 states. Only results with immediate-release, single-agent oxycodone are shown. 2 SNORTING 61% ORAL 47% INJECTING 35% SMOKING 5% REPORTED ROUTES OF ABUSE FOR IMMEDIATE-RELEASE, SINGLE-AGENT OXYCODONE 2 Indications and Usage OXAYDO is indicated for the management of acute and chronic 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 OXAYDO 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. Contraindications OXAYDO 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; hypersensitivity to oxycodone, oxycodone salts, or any components of the product (e.g., anaphylaxis). Warnings and Precautions Addiction, Abuse, and Misuse OXAYDO contains oxycodone, a Schedule II controlled substance. As an opioid, OXAYDO exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OXAYDO. Addiction can occur at recommended dosages and if the drug is misused or abused. 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. Neonatal Opioid Withdrawal Syndrome Prolonged use of OXAYDO during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers Concomitant use of OXAYDO with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of oxycodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of OXAYDO is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in OXAYDO-treated patients may increase oxycodone plasma concentrations and prolong opioid adverse reactions. When using OXAYDO with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in OXAYDO-treated patients, monitor patients closely at frequent intervals and consider dosage reduction of OXAYDO until stable drug effects are achieved. Concomitant use of OXAYDO with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease oxycodone plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to oxycodone. IMPORTANT SAFETY INFORMATION (cont'd) PRESCRIPTION PAIN RELIEVERS IN THE PAST YEAR* 1 12.5 MILLION PEOPLE MISUSED OBTAINED THEIR LAST MISUSED PRESCRIPTION PAIN RELIEVERS FROM A FRIEND OR RELATIVE * 1 54 % OF THE RESPONDENTS WHO MISUSED PRESCRIPTION PAIN RELIEVERS IN THE PAST YEAR, IN A 2015 NATIONAL SURVEY OF PEOPLE 12 AND OLDER, AN ESTI MATED * In the 2015 National Survey on Drug Use and Health of people age 12 and older (N=68,073), 3,199 respondents (4.7%) reported misusing prescription pain relievers in the past year (~93% of which were opioids). When extrapolated to the U.S. population, an estimated 12.5 million Americans age 12 and older misused prescription pain relievers in the past year. Of those respondents who reported misusing pain relievers in the past year (n=3,199), 53.7% reported that they last obtained (given, bought, or took) them from a friend or relative. 1

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