sufentanil citrate injection, USP Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Sufentanil Citrate Injection should be administered only by persons specifically trained in the use of intravenous or epidural anesthetics and management of the respiratory effects of potent opioids.

In patients administered high doses of Sufentanil Citrate Injection, it is essential that qualified personnel and adequate facilities are available for the management of postoperative respiratory depression.

For purposes of administering small volumes of Sufentanil Citrate Injection accurately, the use of a tuberculin syringe or equivalent is recommended.

•
Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available.
•
Individualize dosage based on factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved.
•
Monitor vital signs regularly.
•
The selection of preanesthetic medications should be based upon the needs of the individual patient.
•
The neuromuscular blocking agent selected should be compatible with the patient's condition, taking into account the hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required.

As with other potent opioids, the respiratory depressant effect of sufentanil may persist longer than the measured analgesic effect. The total dose of all opioid agonists administered should be considered by the practitioner before ordering opioid analgesics during recovery from anesthesia.

If Sufentanil Citrate Injection is administered with a CNS depressant, become familiar with the properties of each drug, particularly each product's duration of action. In addition, when such a combination is used, fluids and other countermeasures to manage hypotension should be available [see Warnings and Precautions (5.3)].

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2.2 Intravenous use

Sufentanil Citrate may be administered intravenously by slow injection or infusion.

Adjunct to general anesthesia:

•
Doses of up to 8 mcg/kg (see Table 1)
•
Total Dosage Requirements of 1 mcg/kg/hr or less are recommended
•
Dosage should be individualized and adjusted to remaining operative time anticipated.
Table 1: Adult Dosage Range Chart, Analgesic Component To General Anesthesia, Intravenous Use
Total dosageMaintenance dosage

Duration of anesthesia 1 to 2 hours

Incremental or Infusion: 1 to 2 mcg/kg
Approximately 75% or more of total sufentanil dosage may be administered prior to intubation by either slow injection or infusion titrated to individual patient response.

Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required.

Incremental: 10 to 25 mcg (0.2 to 0.5 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to remaining operative time anticipated.

Infusion: Intermittent or continuous infusion as needed in response to signs of lightening of analgesia.

In absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation.

Maintenance infusion rates should be adjusted based upon the induction dose of sufentanil so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time.

Duration of anesthesia 2 to 8 hours

Incremental or Infusion: 2 to 8 mcg/kg
Approximately 75% or less of the total calculated sufentanil dosage may be administered by slow injection or infusion prior to intubation, titrated to individual patient response.

Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing more complicated major surgical procedures in which endotracheal intubation and mechanical ventilation are required.

At dosages in this range, sufentanil has been shown to provide some attenuation of sympathetic reflex activity in response to surgical stimuli, provide hemodynamic stability, and provide relatively rapid recovery.

Incremental: 10 to 50 mcg (0.2 to 1 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to the remaining operative time anticipated.

Infusion: Intermittent or continuous infusion as needed in response to signs of lightening of analgesia.

In the absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation.

Maintenance infusion rates should be adjusted based upon the induction dose of sufentanil so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time.

Induction And Maintenance Of Anesthesia

•
As the primary anesthetic agent: doses ≥8 mcg/kg (see Dosage Range Chart, Table 2).
•
Dosage should be titrated to individual patient response
•
In children less than 12 years of age undergoing cardiovascular surgery: 10 to 25 mcg/kg administered with 100% oxygen
o
Supplemental dosages of up to 25 to 50 mcg are recommended for maintenance, based on response to initial dose and as determined by changes in vital signs indicating surgical stress or lightening of anesthesia.
Table 2: Dosage Range Chart, Induction and Maintenance of Anesthesia, Intravenous Use

Incremental or Infusion: 8 to 30 mcg/kg
Generally administered as a slow injection, as an infusion, or as an injection followed by an infusion.

Sufentanil with 100% oxygen and a muscle relaxant has been found to produce sleep at dosages ≥8 mcg/kg and to maintain a deep level of anesthesia without the use of additional anesthetic agents. The addition of N2O to these dosages will reduce systolic blood pressure. At dosages in this range of up to 25 mcg/kg, catecholamine release is attenuated.

Dosages of 25 to 30 mcg/kg have been shown to block sympathetic response including catecholamine release.

High doses are indicated in patients undergoing major surgical procedures, in which endotracheal intubation and mechanical ventilation are required, such as cardiovascular surgery and neurosurgery in the sitting position with maintenance of favorable myocardial and cerebral oxygen balance.

Postoperative observation is essential and postoperative mechanical ventilation may be required at the higher dosage range due to extended postoperative respiratory depression.

Incremental: Depending on the initial dose, maintenance doses of 0.5 to 10 mcg/kg may be administered by slow injection in anticipation of surgical stress such as incision, sternotomy or cardiopulmonary bypass.

Infusion: Sufentanil citrate may be administered by continuous or intermittent infusion as needed in response to signs of lightening of anesthesia.

In the absence of lightening of anesthesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation.

The maintenance infusion rate for sufentanil should be based upon the induction dose so that the total dose for the procedure does not exceed 30 mcg/kg.

2.3 Epidural Use in Labor and Delivery

Proper placement of the needle or catheter in the epidural space should be verified before sufentanil citrate is injected to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection of sufentanil could 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 could produce effects of high spinal anesthesia including prolonged paralysis and delayed recovery.

•
Sufentanil should be administered by slow injection. Respiration should be closely monitored following each administration of an epidural injection of sufentanil.
•
If analgesia is inadequate, the placement and integrity of the catheter should be verified prior to the administration of any additional epidural medications.

Dosage for Labor and Delivery

•
10 to 15 mcg administered with 10 mL bupivacaine 0.125% with or without epinephrine.
•
Sufentanil and bupivacaine should be mixed together before administration.
•
Doses can be repeated twice (for a total of three doses) at not less than one-hour intervals until delivery.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Sufentanil Citrate Injection should be administered only by persons specifically trained in the use of intravenous or epidural anesthetics and management of the respiratory effects of potent opioids.

In patients administered high doses of Sufentanil Citrate Injection, it is essential that qualified personnel and adequate facilities are available for the management of postoperative respiratory depression.

For purposes of administering small volumes of Sufentanil Citrate Injection accurately, the use of a tuberculin syringe or equivalent is recommended.

•
Ensure that an opioid antagonist, resuscitative and intubation equipment, and oxygen are readily available.
•
Individualize dosage based on factors such as age, body weight, physical status, underlying pathological condition, use of other drugs, type of anesthesia to be used, and the surgical procedure involved.
•
Monitor vital signs regularly.
•
The selection of preanesthetic medications should be based upon the needs of the individual patient.
•
The neuromuscular blocking agent selected should be compatible with the patient's condition, taking into account the hemodynamic effects of a particular muscle relaxant and the degree of skeletal muscle relaxation required.

As with other potent opioids, the respiratory depressant effect of sufentanil may persist longer than the measured analgesic effect. The total dose of all opioid agonists administered should be considered by the practitioner before ordering opioid analgesics during recovery from anesthesia.

If Sufentanil Citrate Injection is administered with a CNS depressant, become familiar with the properties of each drug, particularly each product's duration of action. In addition, when such a combination is used, fluids and other countermeasures to manage hypotension should be available [see Warnings and Precautions (5.3)].

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2.2 Intravenous use

Sufentanil Citrate may be administered intravenously by slow injection or infusion.

Adjunct to general anesthesia:

•
Doses of up to 8 mcg/kg (see Table 1)
•
Total Dosage Requirements of 1 mcg/kg/hr or less are recommended
•
Dosage should be individualized and adjusted to remaining operative time anticipated.
Table 1: Adult Dosage Range Chart, Analgesic Component To General Anesthesia, Intravenous Use
Total dosageMaintenance dosage

Duration of anesthesia 1 to 2 hours

Incremental or Infusion: 1 to 2 mcg/kg
Approximately 75% or more of total sufentanil dosage may be administered prior to intubation by either slow injection or infusion titrated to individual patient response.

Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing general surgery in which endotracheal intubation and mechanical ventilation are required.

Incremental: 10 to 25 mcg (0.2 to 0.5 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to remaining operative time anticipated.

Infusion: Intermittent or continuous infusion as needed in response to signs of lightening of analgesia.

In absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation.

Maintenance infusion rates should be adjusted based upon the induction dose of sufentanil so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time.

Duration of anesthesia 2 to 8 hours

Incremental or Infusion: 2 to 8 mcg/kg
Approximately 75% or less of the total calculated sufentanil dosage may be administered by slow injection or infusion prior to intubation, titrated to individual patient response.

Dosages in this range are generally administered with nitrous oxide/oxygen in patients undergoing more complicated major surgical procedures in which endotracheal intubation and mechanical ventilation are required.

At dosages in this range, sufentanil has been shown to provide some attenuation of sympathetic reflex activity in response to surgical stimuli, provide hemodynamic stability, and provide relatively rapid recovery.

Incremental: 10 to 50 mcg (0.2 to 1 mL) may be administered in increments as needed when movement and/or changes in vital signs indicate surgical stress or lightening of analgesia. Supplemental dosages should be individualized and adjusted to the remaining operative time anticipated.

Infusion: Intermittent or continuous infusion as needed in response to signs of lightening of analgesia.

In the absence of signs of lightening of analgesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation.

Maintenance infusion rates should be adjusted based upon the induction dose of sufentanil so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time.

Induction And Maintenance Of Anesthesia

•
As the primary anesthetic agent: doses ≥8 mcg/kg (see Dosage Range Chart, Table 2).
•
Dosage should be titrated to individual patient response
•
In children less than 12 years of age undergoing cardiovascular surgery: 10 to 25 mcg/kg administered with 100% oxygen
o
Supplemental dosages of up to 25 to 50 mcg are recommended for maintenance, based on response to initial dose and as determined by changes in vital signs indicating surgical stress or lightening of anesthesia.
Table 2: Dosage Range Chart, Induction and Maintenance of Anesthesia, Intravenous Use

Incremental or Infusion: 8 to 30 mcg/kg
Generally administered as a slow injection, as an infusion, or as an injection followed by an infusion.

Sufentanil with 100% oxygen and a muscle relaxant has been found to produce sleep at dosages ≥8 mcg/kg and to maintain a deep level of anesthesia without the use of additional anesthetic agents. The addition of N2O to these dosages will reduce systolic blood pressure. At dosages in this range of up to 25 mcg/kg, catecholamine release is attenuated.

Dosages of 25 to 30 mcg/kg have been shown to block sympathetic response including catecholamine release.

High doses are indicated in patients undergoing major surgical procedures, in which endotracheal intubation and mechanical ventilation are required, such as cardiovascular surgery and neurosurgery in the sitting position with maintenance of favorable myocardial and cerebral oxygen balance.

Postoperative observation is essential and postoperative mechanical ventilation may be required at the higher dosage range due to extended postoperative respiratory depression.

Incremental: Depending on the initial dose, maintenance doses of 0.5 to 10 mcg/kg may be administered by slow injection in anticipation of surgical stress such as incision, sternotomy or cardiopulmonary bypass.

Infusion: Sufentanil citrate may be administered by continuous or intermittent infusion as needed in response to signs of lightening of anesthesia.

In the absence of lightening of anesthesia, infusion rates should always be adjusted downward until there is some response to surgical stimulation.

The maintenance infusion rate for sufentanil should be based upon the induction dose so that the total dose for the procedure does not exceed 30 mcg/kg.

2.3 Epidural Use in Labor and Delivery

Proper placement of the needle or catheter in the epidural space should be verified before sufentanil citrate is injected to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection of sufentanil could 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 could produce effects of high spinal anesthesia including prolonged paralysis and delayed recovery.

•
Sufentanil should be administered by slow injection. Respiration should be closely monitored following each administration of an epidural injection of sufentanil.
•
If analgesia is inadequate, the placement and integrity of the catheter should be verified prior to the administration of any additional epidural medications.

Dosage for Labor and Delivery

•
10 to 15 mcg administered with 10 mL bupivacaine 0.125% with or without epinephrine.
•
Sufentanil and bupivacaine should be mixed together before administration.
•
Doses can be repeated twice (for a total of three doses) at not less than one-hour intervals until delivery.
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