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SUFentanil

Pronunciation

(soo FEN ta nil)

Index Terms

  • Sufentanil Citrate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous [preservative free]:

Generic: 50 mcg/mL (1 mL); 100 mcg/2 mL (2 mL); 250 mcg/5 mL (5 mL)

Pharmacologic Category

  • Analgesic, Opioid
  • Anilidopiperidine Opioid
  • General Anesthetic

Pharmacology

Binds to opioid receptors throughout the CNS. Once receptor binding occurs, effects are exerted by opening K+ channels and inhibiting Ca++ channels. These mechanisms increase pain threshold, alter pain perception, inhibit ascending pain pathways; short-acting opioid; dose-related inhibition of catecholamine release (up to 30 mcg/kg) controls sympathetic response to surgical stress.

Distribution

Vdss: Children 2 to 8 years: 2.9 ± 0.6 L/kg; Adults: 1.7 ± 0.2 L/kg

Metabolism

Primarily hepatic and small intestine via demethylation and dealkylation

Excretion

Urine (2% excreted as unchanged drug; 80% metabolites) within 24 hours

Clearance:

Children 2 to 8 years: 30.5 ± 8.8 mL/minute/kg

Adolescents: 12.8 ± 12 mL/minute/kg

Adults: 12.7 ± 0.8 mL/minute/kg

Onset of Action

Analgesia: IV: 1 to 3 minutes; Epidural: 10 minutes

Duration of Action

Dose dependent; Epidural: 10 to 15 mcg with bupivacaine 0.125%: 1.7 hours; Anesthesia adjunct doses: 5 minutes

Half-Life Elimination

Neonates: 7.2 ± 2.7 hours; Infants and Children (2 to 8 years): 97 ± 42 minutes; Adolescents 10-15 years: 76 ± 33 minutes; Adults: 164 minutes

Protein Binding

Neonates: 79%; Adults: 91% to 93%; primarily to alpha 1-acid glycoprotein

Use: Labeled Indications

Epidural analgesia: For epidural administration as an analgesic combined with low-dose bupivacaine during labor and vaginal delivery.

Surgical analgesia: Analgesic adjunct for the maintenance of balanced general anesthesia in patients who are intubated and ventilated.

Surgical anesthesia: As a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures; in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position; to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated.

Contraindications

Hypersensitivity (eg, anaphylaxis) to sufentanil or any component of the formulation

Documentation of allergenic cross-reactivity for opioids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Surgical analgesia (as a component of balanced anesthesia) (surgery expected to last: 1 to 2 hours): IV: Total dose: 1 to 2 mcg/kg with N2O/O2; ≥75% of total dose may be administered by slow injection or infusion prior to intubation (titrate to individual response)

Maintenance:

Incremental dosing: According to the manufacturer, 10 to 25 mcg may be administered as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. May also administer doses in the range of 5 to 20 mcg as needed (Barash, 2009) or 0.1 to 0.25 mcg/kg as needed (Miller, 2010). Total dose should not exceed 1 mcg/kg/hour of expected surgical time.

Continuous infusion: May also be administered as a continuous infusion with the infusion rate based on the induction dose used. Maximum infusion rate according to the manufacturer: 1 mcg/kg/hour. May also administer doses in the range of 0.3 to 0.9 mcg/kg/hour (Barash, 2009) or 0.5 to 1.5 mcg/kg/hour (Miller, 2010).

Surgical analgesia (as a component of balanced anesthesia) (surgery expected to last 2 to 8 hours): Total dose: 2 to 8 mcg/kg with N2O/O2; ≤75% of total dose may be administered by slow injection or infusion prior to intubation (titrate to individual response).

Maintenance:

Incremental dosing: According to the manufacturer, 10 to 50 mcg may be administered as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Total dose should not exceed 1 mcg/kg/hour of expected surgical time.

Continuous infusion: May also be administered as a continuous infusion with the infusion rate based on the induction dose used. Maximum infusion rate according to the manufacturer: 1 mcg/kg/hour. May also administer doses in the range of 0.3 to 0.9 mcg/kg/hour (Barash, 2009) or 0.5 to 1.5 mcg/kg/hour (Miller, 2010).

Surgical anesthesia: Total dose: 8 to 30 mcg/kg as a slow injection, infusion, or injection followed by infusion; titrate to individual patient response. Note: In patients administered high doses of sufentanil, qualified personnel and adequate facilities are necessary to manage the potential for postoperative respiratory depression.

Maintenance:

Incremental dosing: 0.5 to 10 mcg/kg as needed in anticipation of surgical stress

Continuous infusion: Base infusion rate on the induction dose so that the total dose for the procedure does not exceed 30 mcg/kg

Analgesia for labor and delivery: Epidural: 10 to 15 mcg with bupivacaine 0.125% with/without epinephrine. Dose can be repeated twice (for a total of 3 doses) at not less than 1-hour intervals until delivery.

Dosing: Geriatric

Refer to adult dosing. Use with caution and titrate slowly; monitor closely for signs of CNS and respiratory depression.

Dosing: Pediatric

Surgical anesthesia (cardiovascular surgery): IV: Children <12 years: Induction: 10 to 25 mcg/kg with 100% O2; maintenance: up to 25 to 50 mcg based on response to initial dose and as determined by changes in vital signs indicating surgical stress or lightening of anesthesia.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution and reduce dose as needed; titrate slowly and closely monitor for signs of CNS and respiratory depression.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution and reduce dose as needed; titrate slowly and closely monitor for signs of CNS and respiratory depression.

Dosing: Obesity

IV: In adult obese patients (eg, >20% above ideal body weight), use lean body weight to determine dosage.

Administration

Intermittent doses may be administered IV as either a slow injection (eg, over at least 2 minutes [Sebel 1982] or a range of 2 to 10 minutes [Miller 2010]) or as an infusion. May also be administered as a continuous infusion.

Compatibility

See Trissel’s IV Compatibility Database

Storage

Store at 20°C to 25°C (68°F to 77°F). Protect from light.

Drug Interactions

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Alvimopan: Analgesics (Opioid) may enhance the adverse/toxic effect of Alvimopan. This is most notable for patients receiving long-term (i.e., more than 7 days) opiates prior to alvimopan initiation. Management: Alvimopan is contraindicated in patients receiving therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan initiation. Consider therapy modification

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Amphetamines: May enhance the analgesic effect of Analgesics (Opioid). Monitor therapy

Analgesics (Opioid): CNS Depressants may enhance the CNS depressant effect of Analgesics (Opioid). Management: Avoid concomitant use of opioid analgesics and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Anticholinergic Agents: May enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Beta-Blockers: Anilidopiperidine Opioids may enhance the bradycardic effect of Beta-Blockers. Anilidopiperidine Opioids may enhance the hypotensive effect of Beta-Blockers. Monitor therapy

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Monitor therapy

Bretylium: May enhance the bradycardic effect of Bradycardia-Causing Agents. Bretylium may also enhance atrioventricular (AV) blockade in patients receiving AV blocking agents. Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): Anilidopiperidine Opioids may enhance the bradycardic effect of Calcium Channel Blockers (Nondihydropyridine). Anilidopiperidine Opioids may enhance the hypotensive effect of Calcium Channel Blockers (Nondihydropyridine). Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Avoid combination

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

CNS Depressants: May enhance the CNS depressant effect of Analgesics (Opioid). Management: Avoid concomitant use of opioid analgesics and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Consider therapy modification

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Desmopressin: Analgesics (Opioid) may enhance the adverse/toxic effect of Desmopressin. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Diuretics: Analgesics (Opioid) may enhance the adverse/toxic effect of Diuretics. Analgesics (Opioid) may diminish the therapeutic effect of Diuretics. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Eluxadoline: Analgesics (Opioid) may enhance the constipating effect of Eluxadoline. Avoid combination

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Gastrointestinal Agents (Prokinetic): Analgesics (Opioid) may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Monitor therapy

Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mixed Agonist / Antagonist Opioids: May diminish the analgesic effect of Analgesics (Opioid). Management: Seek alternatives to mixed agonist/antagonist opioids in patients receiving pure opioid agonists, and monitor for symptoms of therapeutic failure/high dose requirements (or withdrawal in opioid-dependent patients) if patients receive these combinations. Avoid combination

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nalmefene: May diminish the therapeutic effect of Analgesics (Opioid). Management: Avoid the concomitant use of nalmefene and opioid analgesics. Discontinue nalmefene 1 week prior to any anticipated use of opioid analgesics. If combined, larger doses of opioid analgesics will likely be required. Consider therapy modification

Naltrexone: May diminish the therapeutic effect of Analgesics (Opioid). Management: Seek therapeutic alternatives to opioids. See full drug interaction monograph for detailed recommendations. Consider therapy modification

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Pegvisomant: Analgesics (Opioid) may diminish the therapeutic effect of Pegvisomant. Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Ramosetron: Analgesics (Opioid) may enhance the constipating effect of Ramosetron. Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Monitor therapy

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Serotonin Modulators: Analgesics (Opioid) may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Succinylcholine: May enhance the bradycardic effect of Analgesics (Opioid). Monitor therapy

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Adverse Reactions

>10%: Dermatologic: Pruritus (epidural administration: 25%)

1% to 10%:

Cardiovascular: Bradycardia (3% to 9%; dose-related), hypertension (≤9%; more common with IV administration), hypotension (≤9%; more common with IV administration)

Central nervous system: Drowsiness (3% to 9%), central nervous system depression, confusion

Gastrointestinal: Nausea (3% to 9%), vomiting (3% to 9%)

Neuromuscular & skeletal: Chest wall rigidity (3% to 9%; dose-related)

Ophthalmic: Blurred vision

<1% (Limited to important or life-threatening): Anaphylaxis, apnea, biliary colic, bronchospasm, cardiac arrhythmia, chills, circulatory depression, cold and clammy skin, delirium (paradoxical), depression, dizziness, drug dependence (physical and psychological; with prolonged use), dysesthesia, erythema, genitourinary tract spasm, laryngospasm, muscle rigidity, paradoxical central nervous system stimulation, pruritus, respiratory depression (dose-related), seizure, skin rash, tachycardia, urinary retention, urticaria

ALERT: U.S. Boxed Warning

Addiction, abuse, and misuse:

Sufentanil 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.

Warnings/Precautions

Concerns related to adverse effects:

• Bradyarrhythmias: Severe bradycardia may occur; use with caution in patients with bradyarrhythmias.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Hypotension: May cause severe hypotension (including orthostatic hypotension and syncope); use with caution in patients with hypovolemia, cardiovascular disease (including acute MI), or drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics). Monitor for symptoms of hypotension following initiation or dose titration. Use with caution in patients with circulatory shock.

• Respiratory depression: Serious, life-threatening, or fatal respiratory depression, even when used as recommended, may occur. Monitor closely for respiratory depression, especially during initiation or dose escalation. Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids.

• Serotonin syndrome: Potentially life-threatening serotonin syndrome (SS) has occurred with concomitant use of sufentanil and serotonergic agents (eg, SSRIs, SNRIs, triptans, TCAs, 5-HT3 receptor antagonists, mirtazapine, trazodone, tramadol) and agents that impair metabolism of serotonin (eg, MAO inhibitors). Monitor patients closely for signs of SS such as mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis); neuromuscular changes (eg, tremor, rigidity, myoclonus); GI symptoms (eg, nausea, vomiting, diarrhea); and/or seizures. Discontinue sufentanil if serotonin syndrome is suspected.

Disease-related concerns:

• Abdominal conditions: May obscure diagnosis or clinical course of patients with acute abdominal conditions.

• Biliary tract impairment: Use with caution in patients with biliary tract dysfunction, including acute pancreatitis; opioids may cause constriction of sphincter of Oddi.

• CNS depression/coma: Use with caution in patients with impaired consciousness or coma as these patients are susceptible to intracranial effects of CO2 retention.

• Delirium tremens: Use opioids with caution in patients with delirium tremens.

• Head trauma: Use with extreme caution in patients with head injury, intracranial lesions, or elevated intracranial pressure (ICP); exaggerated elevation of ICP may occur.

• Hepatic impairment: Use with caution and reduce dose as needed in patients with hepatic impairment.

• Obesity: Use with caution in patients who are morbidly obese. Consider use of lean body weight for dosing in patients >20% over ideal body weight.

• Prostatic hyperplasia/urinary stricture: Use opioids with caution in patients with prostatic hyperplasia and/or urinary stricture.

• Psychosis: Use opioids with caution in patients with toxic psychosis.

• Renal impairment: Use with caution and reduce dose as needed in patients with renal impairment.

• Respiratory disease: Use with caution and monitor for respiratory depression in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or preexisting respiratory depression, particularly when initiating and titrating therapy; critical respiratory depression may occur, even at therapeutic dosages.

• Seizures: Use with caution in patients with a history of seizure disorders; may increase risk or exacerbate preexisting seizure disorders.

• Thyroid dysfunction: Use opioids with caution in patients with thyroid dysfunction.

Concurrent drug therapy issues:

• Benzodiazepines or other CNS depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in hypotension, profound sedation, respiratory depression, coma, and death. Following the administration of sufentanil, the dose of other CNS depressant drugs should be reduced.

• CYP 3A4 interactions: Use with all CYP3A4 inhibitors may result in an increase in sufentanil plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitant CYP 3A4 inducer may result in increased sufentanil concentrations. Monitor patients receiving sufentanil and any CYP 3A4 inhibitor or inducer.

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Cachectic or debilitated patients: Use with caution in cachectic or debilitated patients; there is a greater potential for critical respiratory depression, even at therapeutic dosages.

• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.

• Pediatric: Use caution in neonates as clearance of sufentanil is much slower than adults; neonates with cardiovascular disease have an even slower clearance. The clearance of sufentanil in children 2 to 8 years of age was shown to be twice as rapid as that seen in adults and adolescents (Lundberg 2011).

Other warnings/precautions:

• Abuse/misuse/diversion: [US Boxed Warning]: Sufentanil exposes 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 sufentanil and monitor all patients regularly for the development of these behaviors and conditions.

• Appropriate use: Epidural: Proper placement of the needle or catheter in the epidural space should be verified before injection to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection may result in a potentially serious overdose, including acute truncal muscular rigidity and apnea. Unintentional intrathecal injection of the full sufentanil/bupivacaine epidural doses and volume may produce effects of high spinal anesthesia including prolonged paralysis and delayed recovery.

• Rapid infusion: Inject slowly over at least 2 minutes (Sebel 1982); rapid IV infusion may result in skeletal muscle and chest wall rigidity, impaired ventilation, or respiratory distress/arrest; nondepolarizing skeletal muscle relaxant may be required.

• Trained individuals: Sufentanil should be administered by health care providers specifically trained in the use of anesthetic agents and should not be used in diagnostic or therapeutic procedures outside the monitored anesthesia setting; resuscitative and intubation equipment should be readily available.

Monitoring Parameters

Pain relief, respiratory and cardiovascular status, blood pressure, and heart rate

Pregnancy Considerations

Adverse event have been observed in some animal reproduction studies. Administration of epidural sufentanil with bupivacaine with or without epinephrine is indicated in labor and delivery. Intravenous use or larger epidural doses are not recommended in pregnant women. When used for pain relief during labor, opioids may temporarily affect the heart rate of the fetus (ACOG 2002).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, fatigue, itching, or muscle rigidity. Have patient report immediately to prescriber signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), noisy breathing, angina, tachycardia, severe dizziness, passing out, confusion, difficulty breathing, slow breathing, shallow breathing, seizures, bradycardia, sexual dysfunction (males), amenorrhea, decreased libido, or infertility (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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