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Sufenta

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Sufenta

INDICATIONS

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 myocar-dial 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 administra-tion, during labor and vaginal delivery. See DOSAGE AND ADMINISTRATION SECTION FOR MORE COMPLETE INFORMATION ON THE USE OF SUFENTA.

DOSAGE AND ADMINISTRATION

The dosage of SUFENTA (sufentanil citrate injection) should be individualized in each case according to body weight, physical status, underlying pathological condition, use of otherdrugs, and type of surgical procedure and anesthesia. In obese patients (more than 20% above ideal total body weight), the dosage of SUFENTA (sufentanil citrate injection) shouldbe 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 (sufentanil citrate injection) is reduced in neonates, especially those with cardiovascular disease, the dose of SUFENTA should be reducedaccordingly (see PRECAUTIONS).

Intravenous use

SUFENTA (sufentanil citrate injection) may be administered intravenously by slow injection or infusion 1) in doses of up to 8 g/kg as an analgesic adjunct to general anesthesia, and 2) in doses ≥ 8 g/kg as a primary anesthetic agent for induction and maintenance of anesthesia (see Dosage Range Chart). If benzodiazepines, barbitu-rates, 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 10-25 g/kg administered with 100% oxygen is generally recommended. Supplemental dosages of up to 25-50 g are recommended for mainte-nance, 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 G/KG/HR OR LESS ARE RECOMMENDED
TOTAL DOSAGE MAINTENANCE DOSAGE
ANALGESIC DOSAGES
Incremental or Infusion: 1-2 g/kg (expected duration of anesthesia 1-2 hours). Approximately 75% or more of total SUFENTA (sufentanil citrate injection) 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: 10-25 g (0.2-0.5 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 (sufentanil citrate injection) 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 (sufentanil citrate injection) so that the total dose does not exceed 1 g/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated.
ANALGESIC DOSAGES
Incremental or Infusion: 2-8 g/kg (expected duration of anesthesia 2-8 hours). Approximately 75% or less of the total calculated SUFENTA (sufentanil citrate injection) 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 (sufentanil citrate injection) 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: 10-50 g (0.2-1 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 g/kg/hr of expected surgical time. Dosage should be individualized and adjusted to remaining operative time anticipated.
ANESTHETIC DOSAGES
Incremental or Infusion: 8-30 g/kg (anesthetic doses). At this anesthetic dosage range SUFENTA (sufentanil citrate injection) is generally administered as a slow injection, as an infusion, or as an injection followed by an infusion. SUFENTA (sufentanil citrate injection) with 100% oxygen and a muscle relaxant has been found to produce sleep at dosages > 8 g/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 g/kg, catecholamine release is attenuated. Dosages of 25-30 g/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 0.5-10 g/kg may be administered by slow injection in anticipation of surgical stress such as incision, sternotomy or cardiopulmonary bypass. Infusion: SUFENTA (sufentanil citrate injection) 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 (sufentanil citrate injection) should be based upon the induction dose so that the total dose for the procedure does not exceed 30 g/kg.

In patients administered high doses of SUFENTA, it is essential that qualified personnel and adequate facilities are available for the management of postoper-ative respiratory depression. Also see WARNINGS and PRECAUTIONS sections. For purposes of administering small volumes of SUFENTA (sufentanil citrate injection) accurately, the use of a tuberculin syringe or equivalent is recommended.

Epidural use in Labor and Delivery
Proper placement of the needle or catheter in the epidural space should be verified before SUFENTA (sufentanil citrate injection) is injected to assure that unintentional intravas-cular or intrathecal administration does not occur. Unintentional intravascular injection of SUFENTA (sufentanil citrate injection) 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 (sufentanil citrate injection) 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 (sufentanil citrate injection) 10-15 g administered with 10 mL bupivacaine 0.125% with or without epinephrine. SUFENTA (sufentanil citrate injection) 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.

HOW SUPPLIED

SUFENTA (sufentanil citrate) Injection is supplied as a sterile aqueous preservative-free solution for intravenous and epidural use as:

NDC 11098-050-01 50 g/mL sufentanil base, 1 mL ampoules in packages of 10
NDC 11098-050-02 50 g/mL sufentanil base, 2 mL ampoules in packages of 10
NDC 11098-050-05 50 g/mL sufentanil base, 5 mL ampoules in packages of 10

Protect from light. Store at controlled room temperature (59°-77°F/15°-25°C).

MAY 1995, SEPTEMBER 1995. Taylor Pharmaceuticals, An akorn Company., Decatur, IL 62522. FDA rev date: 6/4/2007

Last reviewed on RxList: 9/14/2007
This monograph has been modified to include the generic and brand name in many instances.

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