sufentanil

High Alert

IV: Analgesic supplement to general anesthesia; usually with other agents (ultra–short-acting barbiturates, neuromuscular blockers, and inhalation anesthetics) to produce balanced anesthesia in patients who are intubated and ventilated.
Induction/maintenance of anesthesia (with oxygen or oxygen/nitrous oxide and a neuromuscular blocker).
Obstetrical pain during labor and vaginal delivery (in combination with bupivacaine).
Acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Unlabeled Use:

Postoperative pain.

Action ⬆ ⬇

Binds to opioid receptors in the CNS, altering the response to and perception of pain.
Produces CNS depression.

Therapeutic effects:

Supplement in anesthesia.
Decreased pain.

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability. 55% absorbed after SL administration.

Distribution: Does not readily penetrate adipose tissue; crosses the placenta, enters breast milk.

Metabolism/Excretion: Mostly metabolized by the CYP3A4 isoenzyme in the liver; some metabolism in small intestine; ↓ in neonates, further ↓ in neonates with cardiovascular disease.

Half-Life: IV: 2.7 hr (↑ during cardiopulmonary bypass; ↑ in neonates, further ↑ in neonates with cardiovascular disease); SL: 13.4 hr.

Time/Action Profile ⬆ ⬇

(analgesia‡)

ROUTE	ONSET	PEAK	DURATION
Epidural	unknown	unknown	70–90 min
IV	within 1 min	unknown	5 min
SL	1 hr	unknown	unknown

‡Respiratory depression may last longer than analgesia.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity; cross-sensitivity among agents may occur;
Known intolerance;
Significant respiratory depression (SL only);
Severe bronchial asthma (SL only);
Known or suspected GI obstruction (SL only).

Use Cautiously in:

Diabetes;
Severe pulmonary disease;
Hepatic impairment;
Severe renal impairment;
CNS tumors;
↑intracranial pressure;
Head trauma;
Adrenal insufficiency;
Seizure disorder;
Undiagnosed abdominal pain;
Hypothyroidism;
Alcoholism;
Cardiac disease (arrhythmias);
Pancreatitis;
Concurrent use of serotenergic mediations (↑ risk of serotonin syndrome);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk; prolonged use of SL formulation during pregnancy can result in neonatal opioid withdrawal syndrome;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness of SL formulation not established in children;
Geri: risk of respiratory depression in older adults ( dose).

Adv. Reactions/Side Effects ⬆ ⬇

CV: arrhythmias, bradycardia, CARDIAC ARREST, hypotension

Derm: facial itching

EENT: blurred/double vision

Endo: adrenal insufficiency

GI: nausea, biliary spasm, constipation, vomiting

MS: skeletal and thoracic muscle rigidity

Neuro: headache, confusion, dizziness, paradoxical excitation/delirium, postoperative depression, postoperative drowsiness

Resp: allergic bronchospasm, APNEA, LARYNGOSPASM, RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)

Misc: allodynia, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), opioid-induced hyperalgesia, physical dependence, psychological dependence, tolerance

Interactions ⬆ ⬇

Drug-drug:

Avoid use in patients who have received MAO inhibitors within the previous 14 days (may produce unpredictable, potentially fatal reactions).
Use with benzodiazepines or other CNS depressants, including otheropioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, general anesthetics, muscle relaxants, antipsychotics, and alcohol, may cause profound sedation, respiratory depression, coma, and death; reserve concurrent use for when alternative treatment options are inadequate.
Concurrent use of CYP3A4 inhibitors, including clarithromycin, diltiazem, erythromycin, fluconazole, fosamprenavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, and verapamil, ↑ levels and risk of opioid toxicity; careful monitoring during initiation, dose changes, or discontinuation of the inhibitor is recommended.
Concurrent use with CYP3A4 inducers, including carbamazepine, corticosteroids, efavirenz, modafinil, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, or rifampin, may ↓ levels and analgesia; if inducers are discontinued or dosage ↓, patients should be monitored for signs of opioid toxicity, and necessary dose adjustments should be made.
Buprenorphine, butorphanol, or nalbuphine may ↓ analgesia and/or precipitate withdrawal symptoms.
Drugs that affect serotonergic neurotransmitter systems, including tricyclic antidepressants, SSRIs, SNRIs, MAO inhibitors, tramadol, trazodone, mirtazapine, 5-HT3 receptor antagonists, linezolid, methylene blue, and triptans, ↑ risk of serotonin syndrome.
May ↓ the effect of diuretics.
Concurrent use with anticholinergic drugs may ↑ risk of urinary retention and constipation.

Route/Dosage ⬆ ⬇

Low-Dose Anesthesia Adjunct

IV (Adults ): 0.5–2 mcg/kg initially; supplemental doses of 10–25 mcg may be given as needed (not to exceed 1 mcg/kg/hr when administered with nitrous oxide and oxygen).

Moderate-Dose Anesthesia Adjunct

IV (Adults ): 2–8 mcg/kg initially; supplemental doses of 10–50 mcg may be given as needed (not to exceed 1 mcg/kg/hr when administered with nitrous oxide and oxygen).

Primary Anesthesia (with 100% Oxygen)

IV (Adults ): 8–30 mcg/kg initially; supplemental doses of 25–50 mcg may be given as needed or a continuous infusion may be used.
IV (Children ): Cardiovascular surgery: 10–25 mcg/kg initially, followed by maintenance doses of up to 25–50 mcg; clearance in neonates is ↓ and more ↓ in neonates with cardiovascular disease, adjust dose accordingly.

Obstetrical Analgesia

(Adults ): 10–15 mcg in combination with 10 mL of 0.0125% bupivacaine; may be repeated after 1 hr for two additional doses.

Postoperative Pain

(Adults ): 30–60 mcg in 10 mL of 0.9% sodium chloride; additional doses of 25 mcg may be given hourly if needed.

Acute Pain

(Adults ): 30 mcg as needed with a minimum of 1 hr between doses (max = 12 tabs/24 hr).

Availability ⬆ ⬇

(Generic available)

Solution for injection (preservative-free): 50 mcg/mL
Sublingual tablets: 30 mcg

Assessment ⬆ ⬇

Monitor respiratory rate and BP frequently throughout therapy. Report significant changes immediately. The respiratory depressant effects of sufentanil may last longer than the analgesic effects. Monitor closely.
Assess type, location, and intensity of pain before and 3–5 min after IV administration and 1 hr after SL tablet administration when sufentanil is used to treat pain.
Assess risk for opioid addiction, abuse, or misuse prior to administration.

Lab Test Considerations:

May cause ↑ serum amylase and lipase concentrations.

Toxicity and Overdose:

Symptoms of toxicity include respiratory depression, hypotension, arrhythmias, bradycardia, and asystole. Atropine may be used to treat bradycardia. If respiratory depression persists after surgery, prolonged mechanical ventilation may be required. If an opioid antagonist is required to reverse respiratory depression or coma, naloxone is the antidote. Dilute the 0.4-mg ampule of naloxone in 10 mL of 0.9% NaCl and administer 0.5 mL (0.02 mg) by IV push every 2 min. For children and patients weighing <40 kg, dilute 0.1 mg of naloxone in 10 mL of 0.9% NaCl for a concentration of 10 mcg/mL and administer 0.5 mcg/kg every 1–2 min. Titrate dose to avoid withdrawal, seizures, and severe pain. Administration of naloxone in these circumstances, especially in cardiac patients, has resulted in hypertension and tachycardia, occasionally causing left ventricular failure and pulmonary edema.

Implementation ⬆ ⬇

Accidental overdose of opioid analgesics has resulted in fatalities. Before administering, clarify all ambiguous orders; have second practitioner independently check original order, dose calculations, and infusion pump settings.
Do not confuse sufentanil with fentanyl.
- Benzodiazepines may be administered before or after administration of sufentanil to reduce the induction dose requirements, decrease time to loss of consciousness, and produce amnesia. This combination may also increase the risk of hypotension and respiratory depression.
- Opioid antagonists, oxygen, and resuscitative equipment should be readily available during the administration of sufentanil. Sufentanil should be administered IV only in monitored anesthesia care settings (operating room, emergency department, ICU) with immediate access to life support equipment and should be administered only by personnel trained in resuscitation and emergency airway management.
Dsuvia is only available through a restricted program called Dsuvia REMS. Information about Dsuvia REMS can be found at www.DSUVIAREMS.com or by calling 1-855-925-8476.
SL tablets are administered only by a health care professional in a certified medically supervised health care setting and must be discontinued prior to the patient leaving the certified medically supervised setting.
- Administer SL with at least 1 hr between doses. Wear gloves for administration. Follow manufacturer's instructions for use of single-dose applicator. Instruct patient to not chew or swallow the tablet and not eat or drink and minimize talking for 10 min after receiving the tablet. If excessive dry mouth occurs, ice chips may be administered prior to SL administration.
- Explain therapeutic value of medication prior to administration to enhance the analgesic effect.
FDA strongly encourages health care professionals to complete a REMS-compliant education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain, available at www.fda.gov/OpioidAnalgesicREMSBlueprint. Information on programs can be found at 1-800-503-0784 or www.opioidanalgesicrems.com.

IV Administration:

Diluent: Administer undiluted.
Rate: Administer slowly over 1–3 min. Slow IV administration may reduce the incidence and severity of muscle rigidity, bradycardia, or hypotension. Neuromuscular blocking agents may be administered concurrently to decrease muscle rigidity.
Intermittent Infusion: Diluent: May be diluted with D5W or 0.9% NaCl.
Rate: Adjust rate based upon the induction dose so that total dose does not exceed 1 mcg/kg per hr of expected surgical time.

Patient/Family Teaching ⬆ ⬇

Discuss the use of anesthetic agents and the sensations to expect with the patient before surgery.
Explain the purpose of Dsuvia and the pain assessment scale to patient.
Caution patient to change positions slowly to minimize orthostatic hypotension.
May causes dizziness and drowsiness. Advise patient to call for assistance during ambulation and transfer and to avoid driving or other activities requiring alertness for 24 hr after administration during outpatient surgery.
Instruct patient to avoid alcohol or other CNS depressants for 24 hr after administration for outpatient surgery.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. Inform patient of potential for neonatal opioid withdrawal syndrome with prolonged use during pregnancy. Monitor neonate for signs and symptoms of withdrawal symptoms (irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight); usually occur the first days after birth.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇