Outpatient Surgery Magazine

Backbreaker - April 2019 - Subscribe to Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

Issue link: http://magazine.outpatientsurgery.net/i/1101250

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Page 15 of 146

BRIEF SUMMARY OF PRESCRIBING INFORMATION This brief summary does not include all the information needed to use DILAUDID INJECTION safely and effectively. Please see full prescribing information for DILAUDID INJECTION, including BOXED WARNING, at www.fresenius-kabi.com/us. WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE- THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS Addiction, Abuse, and Misuse DILAUDID INJECTION 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 DILAUDID INJECTION 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 DILAUDID INJECTION. Monitor for respiratory depression, especially during initiation of DILAUDID INJECTION or following a dose increase. Neonatal Opioid Withdrawal Syndrome Prolonged use of DILAUDID INJECTION 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. 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 DILAUDID 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. INDICATIONS AND USAGE DILAUDID INJECTION is an opioid agonist 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, or are not expected to be tolerated • Have not provided adequate analgesia, or are not expected to provide adequate analgesia CONTRAINDICATIONS 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, including paralytic ileus. • Known hypersensitivity to hydromorphone, hydromorphone salts, sulfite-containing medications, or any other components of the product. WARNINGS AND PRECAUTIONS (also see BOXED WARNING) • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely at initiation, dose titration. See Contraindications for use in patients with bronchial asthma. • Adrenal Insufficiency: If diagnosed, wean the patient off of the opioid and treat with physiologic replacement doses of corticosteroids. • 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 of DILAUDID INJECTION in patients with impaired consciousness or coma. • Risks of Use in Patients with Gastrointestinal Conditions: The hydromorphone in DILAUDID INJECTION may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. • Increased Risk of Seizures in Patients with Seizure Disorders: Monitor patients with a history of seizure disorders for worsened seizure control. • Withdrawal: When discontinuing DILAUDID INJECTION in a physically-dependent patient, gradually taper the dosage. Do not abruptly discontinue therapy in physically-dependent patients. • Risks of Driving and Operating Machinery: DILAUDID INJECTION may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of DILAUDID INJECTION and know how they will react to the medication. • Sulfites: DILAUDID INJECTION contains sodium metabisulfite. See Contraindications. • Increased Risk of Hypotension and Respiratory Depression with Rapid Intravenous Administration: should be given very slowly. ADVERSE REACTIONS (see Boxed Warning and Warnings and Precautions) Serious adverse reactions: Addiction, abuse, and misuse, life- threatening respiratory depression, neonatal opioid withdrawal syndrome, interactions with benzodiazepines and other CNS depressants, adrenal insufficiency, severe hypotension, gastrointestinal adverse reactions, seizures, withdrawal, respiratory depression and apnea, circulatory depression, respiratory arrest, shock, and cardiac arrest. Most common adverse reactions: Lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. Less frequently observed adverse reactions: tachycardia, bradycardia, palpitations, blurred vision, diplopia, miosis, visual impairment, constipation, ileus, diarrhea, abdominal pain, weakness, feeling abnormal, chills, injection site uticaria, fatigue, injection site reactions, peripheral edema, biliary colic, anaphylactic reactions, hypersensitivity reactions, increase in hepatic enzymes, decreased appetite, muscle rigidity, headache, tremor, paraesthesia, nystagmus, increased intracranial pressure, syncope, taste alteration, involuntary muscle contractions, presyncope, convulsion, drowsiness, dyskinesia, hyperalgesia, lethargy, myoclonus, somnolence, agitation, mood altered, nervousness, anxiety, depression, hallucination, disorientation, insomnia, abnormal dreams, urinary retention, urinary hesitation, antidiuretic effects, erectile dysfunction, bronchospasm, laryngospasm, dyspnea, oropharyngeal swelling, injection site pain, urticaria, rash, hyperhidrosis, flushing, hypotension, hypertension, serotonin syndrome, and androgen deficiency. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA at 1-800-551-7176 option 5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS • Pregnancy: May cause fetal harm (see BOXED WARNING for neonatal opioid withdrawal syndrome). • Labor or Delivery: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. Naloxone must be available for reversal. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. • Lactation: Low levels of opioid analgesics have been detected in human milk. Monitor infants for excess sedation and respiratory depression. Withdrawal symptoms can occur in breastfed infants when maternal administration of hydromorphone is stopped, or when breast-feeding is stopped. • 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 and effectiveness of DILAUDID INJECTION in pediatric patients has not been established. • Geriatric Use: Patients 65 years of age or older may have increased sensitivity to hydromorphone. Start at the low end of the dosing range, titrate the dosage slowly and monitor for signs of CNS and respiratory depression. • Hepatic and Renal Impairment: Start patients on one-fourth to one-half the usual starting dose depending on the degree of impairment and closely monitor during dose titration. DRUG INTERACTIONS Clinically significant drug interactions with DILAUDID INJECTION: benzodiazepines and other CNS depressants, serotonergic and anticholinergic drugs, monoamine oxidase inhibitors (MAOIs), mixed agonist/antagonist and partial agonist opioid analgesics, muscle relaxants, diuretics. OVERDOSAGE Acute overdose with DILAUDID INJECTION can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis, rather than miosis, may be seen with hypoxia in overdose situations. In case of overdose, reestablish patent and protected airway, institute assisted or controlled ventilation, manage circulatory shock, pulmonary edema, cardiac arrest or arrhythmias, as indicated. Administer opioid antagonists only for clinically significant respiratory or circulatory depression. Carefully monitor the patient until spontaneous respiration is reestablished. Administration of opioid antagonist in a physically dependent patient should be initiated with care and by titration with smaller than usual doses of the antagonist. Simplist ® Dilaudid ® Injection (hydromorphone hydrochloride) CII, for intravenous, intramuscular, or subcutaneous use

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