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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Adverse Reactions Serious adverse reactions that may be associated with OXAYDO include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock. The most frequent of the adverse reactions include nausea, constipation, vomiting, headache, and pruritus. Additional Drug Interactions Serotonergic Drugs The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Monoamine Oxidase Inhibitors (MAOIs) MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics May reduce the analgesic effect of OXAYDO and/or precipitate withdrawal symptoms. Muscle Relaxants Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Diuretics Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Anticholinergic Drugs The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Use in Specific Populations Pregnancy Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. There are no available data with OXAYDO in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Labor or Delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. OXAYDO is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate. Opioid analgesics, including OXAYDO, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Lactation Oxycodone is present in breast milk. Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, breastfeeding is not recommended during treatment with OXAYDO. Females and Males of Reproductive Potential Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible. Pediatric Use The safety, effectiveness, and pharmacokinetics of OXAYDO in pediatric patients below the age of 18 have not been established. Geriatric Use Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of OXAYDO slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression. Hepatic Impairment Since oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. Follow a conservative approach to initiate dosing in patients with hepatic impairment. Monitor patients closely and adjust the dose based on clinical response. Renal Impairment Information from oxycodone HCl indicates that patients with renal impairment had higher plasma concentrations of oxycodone than subjects with normal renal function. Use a conservative approach to initiate dosing in patients with renal impairment. Monitor patients closely and adjust the dose based on clinical response. Formulated with an inactive ingredient that may cause nasal burning and throat irritation when snorted 3 Contains sodium lauryl sulfate, which is found in soap, shampoo, and other personal hygiene products Does not contain acetaminophen Familiar molecule — bioequivalent to immediate-release oxycodone in the fasted state Available in the lowest dosage strength for a single-entity immediate- release oxycodone, 5 mg and a unique 7.5 mg strength 4 When starting an opioid therapy for chronic pain, the CDC recommends prescribing opioids at the lowest effective dosage 5 Eligible patients with commercial insurance pay no more than $15 with the My OXAYDO Patient Savings Program.* *Terms and conditions apply. Printed in U.S.A. © 2017 Egalet US Inc. 17-OX-057 June 2017

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