Drug Detail:Sufentanil (monograph) (Sufenta)
Drug Class:
Usual Adult Dose for Anesthesia
Doses should be individualized and titrated to the desired effect according to body weight, physical status, underlying pathological condition, use of other drugs, and type and duration of surgical procedure, and anesthesia:
ADJUNCT TO GENERAL ANESTHESIA: Total Dosage Requirement: 1 mcg/kg/hr or less (expected surgical time)
- Duration of Anesthesia: 1 TO 2 HOURS:
- Approximately 75% or more of total dosage may be administered prior to intubation
- Duration of Anesthesia: 2 TO 8 HOURS:
- Approximately 75% or less of total dosage may be administered prior to intubation
INDUCTION AND MAINTENANCE OF ANESTHESIA:
As primary anesthetic agent: 8 mcg/kg or greater
- Incremental IV injection: Depending on initial dose, follow with maintenance doses of 0.5 to 1 mcg/kg IV in anticipation of surgical stress
- IV Infusion: Generally initiated with a slow IV injection then followed with continuous or intermittent IV infusion in response to lightening of anesthesia
Comments:
- Doses of 25 to 30 mcg/kg have been shown to block sympathetic response including catecholamine release.
- Postoperative observation is essential; postoperative mechanical ventilation may be required at the higher dose range due to extended postoperative respiratory depression.
Uses: As a primary anesthetic or an analgesic adjunct for patients intubated and ventilated.
Usual Adult Dose for Labor Pain
10 to 15 mcg with 10 mL of bupivacaine 0.125% with or without epinephrine
- Dose may be repeated up to 2 more times at not less than 1-hour intervals until delivery
Comments:
- This drug should be mixed with bupivacaine before administration
- Prior to administering this drug, proper placement of needle or catheter in the epidural space should be verified; if analgesia is inadequate, placement and integrity of catheter should be verified prior to administration of any additional medication.
Use: As an analgesic (in combination with bupivacaine) during labor and vaginal delivery.
Usual Adult Dose for Pain
30 mcg sublingually once; may repeat dose as needing allowing a minimum of 1 hour between doses
Maximum dose: 360 mcg (12 tablets) in 24 hours
Maximum duration: 72 hours
Comments:
- This drug is for use in a certified medically supervised healthcare setting, such as hospital, surgical center, and emergency department; it should be administered by a healthcare professional.
- This drug is not for home use and not to be used beyond 72 hours.
- Due to risks of addiction, abuse, and misuse with opioids, this drug should be reserved for use in patients for whom alternative options such as non-opioid analgesics or opioid combination products have not been or are not expected to be tolerated; or have not provided or are not expected to provide adequate analgesia.
Use: For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Usual Pediatric Dose for Anesthesia
Doses should be individualized and titrated to the desired effect according to body weight, physical status, underlying pathological condition, use of other drugs, and type and duration of surgical procedure, and anesthesia:
ADJUNCT TO GENERAL ANESTHESIA: Total Dosage Requirement: 1 mcg/kg/hr or less (expected surgical time)
- Duration of Anesthesia: 1 TO 2 HOURS:
- Approximately 75% or more of total dosage may be administered prior to intubation
- Duration of Anesthesia: 2 TO 8 HOURS:
- Approximately 75% or less of total dosage may be administered prior to intubation
INDUCTION AND MAINTENANCE OF ANESTHESIA:
As primary anesthetic agent: 8 mcg/kg or greater
- Incremental IV injection: Depending on initial dose, follow with maintenance doses of 0.5 to 1 mcg/kg IV in anticipation of surgical stress
- IV Infusion: Generally initiated with a slow IV injection then followed with continuous or intermittent IV infusion in response to lightening of anesthesia
Cardiovascular Surgery:
Less than 12 years: 10 to 25 mcg/kg IV (administered with 100% oxygen)
- Maintenance: Supplemental doses 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
Comments:
- Limited data have shown use of this drug in patients as young as 1 day old undergoing cardiovascular surgery; clearance in healthy neonates is approximately one-half of adults and children and further reduced (up to one-third) in neonates with cardiovascular disease.
- Postoperative observation is essential; postoperative mechanical ventilation may be required at the higher dose range due to extended postoperative respiratory depression.
Uses: As a primary anesthetic or an analgesic adjunct for patients intubated and ventilated.
Renal Dose Adjustments
Use with caution, dosage adjustments may be required; however, no specific guidelines have been suggested.
- More frequent monitoring for signs of respiratory depression, sedation, and hypotension are recommended, especially in patients with severe renal impairment.
Liver Dose Adjustments
Use with caution, dosage adjustments may be required; however, no specific guidelines have been suggested.
- More frequent monitoring for signs of respiratory depression, sedation, and hypotension are recommended due to extensive hepatic metabolism
Dose Adjustments
Elderly: Use caution generally starting at the low end of the dosing range and titrate slowly; monitor closely for signs of CNS and respiratory depression
Concomitant Use or Discontinuation of CYP450 3A4 Inhibitors or Inducers:
- Monitor patients closely and at frequent intervals; consider dose adjustments as clinically appropriate
Precautions
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Dsuvia(R). It includes elements to assure safe use and an implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm
US BOXED WARNING: SUBLINGUAL TABLET
- ACCIDENTAL EXPOSURE AND REMS PROGRAM: Accidental exposure or ingestion of the sublingual tablet, especially in children, can result in respiratory depression and death. Because of the potential for life-threatening respiratory depression due to accidental exposure, this drug is only available through a restricted REMS program. This drug must only be dispensed to patients in a certified medically supervised healthcare setting; this drug must be discontinued prior to discharge or transfer from the certified medically supervised healthcare setting.
- LIFE-THREATENING RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation.
- ADDICTION, ABUSE, AND MISUSE: This drug 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 and monitor all patients regularly for the development of these behaviors or conditions.
- CYP450 3A4 INTERACTION: The concomitant use with CYP450 3A4 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 concomitantly used CYP450 3A4 inducer may result in an increase in sufentanil plasma concentration. Monitor patients receiving sufentanil and any CYP450 3A4 inhibitor or inducer.
- RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS including alcohol, may result in profound sedation, respiratory depression, coma, and death. Concomitant use should be reserved for those patients for whom alternative treatment options are inadequate. If needed, limit dose and duration to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.
US BOXED WARNING: INJECTION
- This drug exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Asses patient's risk before prescribing and monitor regularly for these behaviors and conditions.
CONTRAINDICATIONS:
- Known hypersensitivity to active substance or any product excipients
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected gastrointestinal obstruction, including paralytic ileus
Safety and efficacy of sublingual tablets have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule II
Dialysis
Data not available
Other Comments
Administration advice:
IV: Administer via slow injection or infusion
Epidural:
- Ensure proper placement of needle/catheter in epidural space prior to injection
- This drug is intended to be administered with bupivacaine
Sublingual Tablet:
- To be administered by healthcare provider in a certified medically supervised healthcare setting; gloves should be worn when administering
- Patient should be instructed not to chew or swallow tablet
- Patient should not eat or drink and minimize talking for 10 minutes after receiving tablet; if patient has excessive dry mouth, ice chips should be provided prior to administration
Storage requirements:
Ampules: Protect from light
Reconstitution/preparation techniques: Consult Manufacturer Package Insert
Epidural use: Mix with bupivacaine prior to administration
Sublingual use: Administer with Single-Dose-Applicator (SDA); SDA should be disposed in biohazard waste after administration
General:
- Administration of this drug is restricted to those healthcare professionals specifically trained in the use of anesthetics and the management of the respiratory effects of potent opioids.
- This drug should be administered in facilities that have qualified personnel and are adequately equipped to handle any degree of respiratory depression; opioid antagonists, resuscitative and intubation equipment, and oxygen should be readily available during drug administration.
Monitoring:
- Vital signs should be continuously monitored during and after use
- Monitor oxygen saturation and watch for early signs of hypotension, apnea, upper airway obstruction and/or oxygen desaturation
- Elderly, debilitated patients, patients with brain tumors or head injuries, those on concomitant medications including CNS depressants, CYP450 3A4 inhibitors/inducers, serotonergic medications, or neuromuscular blocking agents should be observed very closely
Patient advice:
- Patients should be advised not to drive or operate machinery for a sufficient time after having received this drug.
Frequently asked questions
- What is the Dsuvia REMS program?
- How do you take the Dsuvia (sufentanil) tablet?
- Is Dsuvia (sufentanil) a controlled substance?
