INDICATIONS AND USAGE
SUFENTA (sufentanil citrate) is indicated for intravenous administration in adults and pediatric patients:
as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated.
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.
SUFENTA (sufentanil citrate) is indicated for epidural administration as an analgesic combined with low dose bupivacaine, usually 12.5 mg per administration, during labor and vaginal delivery.
SEE DOSAGE AND ADMINISTRATION SECTION FOR MORE COMPLETE INFORMATION ON THE USE OF SUFENTA.
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DOSAGE AND ADMINISTRATION
The dosage of SUFENTA should be individualized in each case according to body weight, physical status, underlying pathological condition, use of other drugs, and type of surgical procedure and anesthesia. In obese patients (more than 20% above ideal total body weight), the dosage of SUFENTA should be determined on the basis of lean body weight. Dosage should be reduced in elderly and debilitated patients (see PRECAUTIONS).
Vital signs should be monitored routinely.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because the clearance of SUFENTA is reduced in neonates, especially those with cardiovascular disease, the dose of SUFENTA should be reduced accordingly (see PRECAUTIONS).
Intravenous use
SUFENTA may be administered intravenously by slow injection or infusion 1) in doses of up to 8 mcg/kg as an analgesic adjunct to general anesthesia, and 2) in doses ≥8 mcg/kg as a primary anesthetic agent for induction and maintenance of anesthesia (see Dosage Range Chart). If benzodiazepines, barbiturates, inhalation agents, other opioids or other central nervous system depressants are used concomitantly, the dose of SUFENTA and/or these agents should be reduced (see PRECAUTIONS). In all cases dosage should be titrated to individual patient response.
Usage in Children
For induction and maintenance of anesthesia in children less than 12 years of age undergoing cardiovascular surgery, an anesthetic dose of 10 to 25 mcg/kg administered with 100% oxygen is generally recommended. 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.
Premedication
The selection of preanesthetic medications should be based upon the needs of the individual patient.
Neuromuscular Blocking Agents
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 (see CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS).
ADULT DOSAGE RANGE CHART for Intravenous use ANALGESIC COMPONENT TO GENERAL ANESTHESIA
•TOTAL DOSAGE REQUIREMENTS OF 1 MCG/KG/HR OR LESS ARE RECOMMENDED |
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| TOTAL DOSAGE | MAINTENANCE DOSAGE |
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| ANALGESIC DOSAGES |
| Incremental or Infusion: 1 to 2 mcg/kg (expected duration of anesthesia 1 to 2 hours). Approximately 75% or more of total SUFENTA 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: SUFENTA may be administered as an 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 SUFENTA so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated. |
| ANALGESIC DOSAGES |
| Incremental or Infusion: 2 to 8 mcg/kg (expected duration of anesthesia 2 to 8 hours). Approximately 75% or less of the total calculated SUFENTA 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, SUFENTA 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: SUFENTA may be administered as an 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 SUFENTA so that the total dose does not exceed 1 mcg/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated. |
| ANESTHETIC DOSAGES |
| Incremental or Infusion: 8 to 30 mcg/kg (anesthetic doses). At this anesthetic dosage range SUFENTA is generally administered as a slow injection, as an infusion, or as an injection followed by an infusion. SUFENTA 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. Dosage should be titrated to individual patient response. | 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: SUFENTA 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 SUFENTA should be based upon the induction dose so that the total dose for the procedure does not exceed 30 mcg/kg. |
In patients administered high doses of SUFENTA, it is essential that qualified personnel and adequate facilities are available for the management of postoperative respiratory depression.
Also see WARNINGS and PRECAUTIONS sections.
For purposes of administering small volumes of SUFENTA accurately, the use of a tuberculin syringe or equivalent is recommended.
| Epidural use in Labor and Delivery |
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| Proper placement of the needle or catheter in the epidural space should be verified before SUFENTA is injected to assure that unintentional intravascular or intrathecal administration does not occur. Unintentional intravascular injection of SUFENTA 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. If analgesia is inadequate, the placement and integrity of the catheter should be verified prior to the administration of any additional epidural medications. SUFENTA should be administered by slow injection. Respiration should be closely monitored following each administration of an epidural injection of SUFENTA. |
| Dosage for Labor and Delivery: The recommended dosage is SUFENTA 10 to 15 mcg administered with 10 mL bupivacaine 0.125% with or without epinephrine. SUFENTA 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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HOW SUPPLIED
SUFENTA (Sufentanil Citrate Injection, USP) is supplied as a sterile aqueous preservative-free solution for intravenous and epidural use as:
NDC 11098-050-01 50 mcg/mL sufentanil base, 1 mL ampules in packages of 10
NDC 11098-050-02 50 mcg/mL sufentanil base, 2 mL ampules in packages of 10
NDC 11098-050-05 50 mcg/mL sufentanil base, 5 mL ampules in packages of 10
STORAGE
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. PROTECT FROM LIGHT.
U.S. Patent No. 3,998,834
MAY 1995, SEPTEMBER 1995
TAYLOR PHARMACEUTICALS
AN AKORN COMPANY
Decatur, IL 62522
SFA0N
Rev. 07/07
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