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INDICATIONS AND USAGE DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve DILAUDID INJECTION for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: have not been tolerated, are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia. IMPORTANT SAFETY INFORMATION DILAUDID INJECTION is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment, known or suspected gastrointestinal obstruction, known hypersensitivity to hydromorphone, hydromorphone salts, sulfite-containing medications, or any other components of the product. Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation and titration. Adrenal insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Severe hypotension: Monitor during dosage initiation and titration. Avoid use in patients with circulatory shock. Risks of use in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness: Monitor for sedation and respiratory depression. Avoid use in patients with impaired consciousness or coma. Additional serious adverse reactions: Apnea, circulatory depression, respiratory arrest, shock, cardiac arrest, seizures, withdrawal, anaphylaxis. Most common adverse reactions: Lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DILAUDID INJECTION contains sodium metabisulfite. Overdosage: Acute overdose can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, miosis (or mydriasis when hypoxia is present), and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. This Important Safety Information does not include all the information needed to use DILAUDID safely and effectively. Please see the following page for brief summary of prescribing information for DILAUDID INJECTION, including Boxed Warning. Full prescribing information is available at www.simplist-us.com. References: 1. Institute for Safe Medication Practices. Risk control strategies for reducing patient harm with hydromorphone. http://www.ismp.org/tools/ hydromorphone.asp. (Last visited February 14, 2017). 2. The Joint Commission. Safe use of opioids in hospitals. http://www.jointcommission.org/sea_issue_49/. Published August 8, 2012. (Last visited February 14, 2017). 3. Institute for Safe Medication Practices. ISMP safe practice guidelines for adult IV push medications. http://www.ismp.org/Tools/guidelines/ivsummitpush/ivpushmedguidelines.pdf. Published 2015. (Last visited February 14, 2017). WARNING: RISK OF MEDICATION ERRORS, ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS • DILAUDID INJECTION exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. • Prolonged use of DILAUDID INJECTION during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. • 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 for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. ©2017, Fresenius Kabi USA, LLC. All Rights Reserved. 1325-SIM-05-04/17 Learn more at simplist-us.com 1.888.386.1300 I www.fresenius-kabi.us