Cisatracurium Besylate

Cisatracurium Besylate Manufacturers

• Sandoz Inc
  

  ×

  Cisatracurium Besylate | Sandoz Inc

  

  ---

  CISATRACURIUM BESYLATE INJECTION SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY.

  The dosage information provided below is intended as a guide only. Doses of cisatracuriumbesylate injection should be individualized (see CLINICAL PHARMACOLOGY- Individualization of Dosages). The use of a peripheral nerve stimulator will permit the most advantageous use of cisatracuriumbesylate injection, minimize the possibility of overdosage or underdosage, and assist in the evaluation of recovery.

  Adults

  Initial Doses

  One of two intubating doses of cisatracurium besylate may be chosen, based on the desired time to tracheal intubation and the anticipated length of surgery. In addition to the dose of neuromuscular blocking agent, the presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia are factors that can influence intubation conditions. Doses of 0.15 (3 × ED95) and 0.20 (4 × ED95) mg/kg cisatracurium besylate, as components of a propofol/nitrous oxide/oxygen induction-intubation technique, may produce generally GOOD or EXCELLENT conditions for intubation in 2 and 1.5 minutes, respectively. Similar intubation conditions may be expected when these doses of cisatracurium besylate are administered as components of a thiopental/nitrous oxide/oxygen induction-intubation technique. In two intubation studies using thiopental or propofol and midazolam and fentanyl as co-induction agents, EXCELLENT intubation conditions were most frequently achieved with the 0.2 mg/kg compared to 0.15 mg/kg dose of cisatracurium besylate injection. The clinically effective durations of action for 0.15 and 0.20 mg/kg cisatracurium besylate injection during propofol anesthesia are 55 minutes (range: 44 to 74 minutes) and 61 minutes (range: 41 to 81 minutes), respectively. Lower doses may result in a longer time for the development of satisfactory intubation conditions. Doses up to 8 × ED95 cisatracurium besylate injection have been safely administered to healthy adult patients and patients with serious cardiovascular disease. These larger doses are associated with longer clinically effective durations of action (see CLINICAL PHARMACOLOGY).

  Because slower times to onset of complete neuromuscular block were observed in elderly patients and patients with renal dysfunction, extending the interval between administration of cisatracurium besylate injection and the intubation attempt for these patients may be required to achieve adequate intubation conditions.

  A dose of 0.03 mg/kg cisatracurium besylate injection is recommended for maintenance of neuromuscular block during prolonged surgical procedures. Maintenance doses of 0.03 mg/kg each sustain neuromuscular block for approximately 20 minutes. Maintenance dosing is generally required 40 to 50 minutes following an initial dose of 0.15 mg/kg cisatracurium besylate and 50 to 60 minutes following an initial dose of 0.20 mg/kg cisatracurium besylate, but the need for maintenance doses should be determined by clinical criteria. For shorter or longer durations of action, smaller or larger maintenance doses may be administered.

  Isoflurane or enflurane administered with nitrous oxide/oxygen to achieve 1.25 MAC (Minimum Alveolar Concentration) may prolong the clinically effective duration of action of initial and maintenance doses. The magnitude of these effects may depend on the duration of administration of the volatile agents. Fifteen to 30 minutes of exposure to 1.25 MAC isoflurane or enflurane had minimal effects on the duration of action of initial doses of cisatracurium besylate injection and therefore, no adjustment to the initial dose should be necessary when cisatracurium besylate injection is administered shortly after initiation of volatile agents. In long surgical procedures during enflurane or isoflurane anesthesia, less frequent maintenance dosing or lower maintenance doses of cisatracurium besylate injection may be necessary. No adjustments to the initial dose of cisatracurium besylate injection are required when used in patients receiving propofol anesthesia.

  Children

  Initial Doses

  The recommended dose of cisatracurium besylate injection for children 2 to 12 years of age is 0.10-0.15 mg/kg administered over 5 to 10 seconds during either halothane or opioid anesthesia. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.10 mg/kg cisatracurium besylate injection produces maximum neuromuscular block in an average of 2.8 minutes (range: 1.8 to 6.7 minutes) and clinically effective block for 28 minutes (range: 21 to 38 minutes). When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate produces maximum neuromuscular block in about 3 minutes (range: 1.5 to 8 minutes) and clinically effective block (time to 25% recovery) for 36 minutes (range:  29 to 46 minutes).

  Infants

  Initial Doses

  The recommended dose of cisatracurium besylate injection for intubation of infants 1 month to 23 months is 0.15 mg/kg administered over 5 to 10 seconds during either halothane or opioid anesthesia. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate produces maximum neuromuscular block in about 2 minutes (range: 1.3 to 3.4 minutes) and clinically effective block (time to 25% recovery) for about 43 minutes (range: 34 to 58 minutes).

  Use by Continuous Infusion

  Infusion in the Operating Room (OR)

  After administration of an initial bolus dose of cisatracurium besylate, a diluted solution of cisatracurium besylate injection can be administered by continuous infusion to adults and children aged 2 or more years for maintenance of neuromuscular block during extended surgical procedures. Infusion of cisatracurium besylate injection should be individualized for each patient. The rate of administration should be adjusted according to the patient's response as determined by peripheral nerve stimulation. Accurate dosing is best achieved using a precision infusion device.

  Infusion of cisatracurium besylate injection should be initiated only after early evidence of spontaneous recovery from the initial bolus dose. An initial infusion rate of 3 mcg/kg/min may be required to rapidly counteract the spontaneous recovery of neuromuscular function. Thereafter, a rate of 1 to 2 mcg/kg/min should be adequate to maintain continuous neuromuscular block in the range of 89% to 99% in most pediatric and adult patients under opioid/nitrous oxide/oxygen anesthesia.

  Reduction of the infusion rate by up to 30% to 40% should be considered when cisatracurium besylate injection is administered during stable isoflurane or enflurane anesthesia (administered with nitrous oxide/oxygen at the 1.25 MAC level). Greater reductions in the infusion rate of cisatracurium besylate injection may be required with longer durations of administration of isoflurane or enflurane.

  The rate of infusion of atracurium required to maintain adequate surgical relaxation in patients undergoing coronary artery bypass surgery with induced hypothermia (25° to 28°C) is approximately half the rate required during normothermia. Based on the structural similarity between cisatracurium besylate injection and atracurium, a similar effect on the infusion rate of cisatracurium besylate injection may be expected.

  Spontaneous recovery from neuromuscular block following discontinuation of infusion of cisatracurium besylate may be expected to proceed at a rate comparable to that following administration of a single bolus dose.

  Infusion in the Intensive Care Unit (ICU)

  The principles for infusion of cisatracurium besylate injection in the OR are also applicable to use in the ICU. An infusion rate of approximately 3 mcg/kg/min (range: 0.5 to 10.2 mcg/kg/min) should provide adequate neuromuscular block in adult patients in the ICU. There may be wide interpatient variability in dosage requirements and these may increase or decrease with time (see PRECAUTIONS - Long-Term Use in the Intensive Care Unit (ICU)). Following recovery from neuromuscular block, readministration of a bolus dose may be necessary to quickly re-establish neuromuscular block prior to reinstitution of the infusion.

  Infusion Rate Tables

  The amount of infusion solution required per minute will depend upon the concentration of cisatracurium besylate in the infusion solution, the desired dose of cisatracurium besylate, and the patient's weight. The contribution of the infusion solution to the fluid requirements of the patient also must be considered. Tables 10 and 11 provide guidelines for delivery, in mL/hr (equivalent to microdrops/minute when 60 microdrops = 1 mL), of cisatracurium besylate solutions in concentrations of 0.1 mg/mL (10 mg/100 mL) or 0.4 mg/mL (40 mg/100 mL).

  Table 10. Infusion Rates of Cisatracurium Besylate for Maintenance of Neuromuscular Block During Opioid/Nitrous Oxide/Oxygen Anesthesia for a Concentration of 0.1 mg/mL Drug Delivery Rate (mcg/kg/min)

  1

  1.5

  2

  3

  5

  Patient Weight (kg)

  Infusion Delivery Rate (mL/hr)

  10

  6

  9

  12

  18

  30

  45

  27

  41

  54

  81

  135

  70

  42

  63

  84

  126

  210

  100

  60

  90

  120

  180

  300

  Table 11. Infusion Rates of Cisatracurium Besylate for Maintenance of Neuromuscular Block During Opioid/Nitrous Oxide/Oxygen Anesthesia for a Concentration of 0.4 mg/mL Drug Delivery Rate (mcg/kg/min)

  1

  1.5

  2

  3

  5

  Patient Weight (kg)

  Infusion Delivery Rate (mL/hr)

  10

  1.5

  2.3

  3

  4.5

  7.5

  45

  6.8

  10.1

  13.5

  20.3

  33.8

  70

  10.5

  15.8

  21

  31.5

  52.5

  100

  15

  22.5

  30

  45

  75

  Cisatracurium Besylate Injection Compatibility and Admixtures

  Y-site Administration

  Cisatracurium besylate injection is acidic (pH = 3.25 to 3.65) and may not be compatible with alkaline solution having a pH greater than 8.5 (e.g., barbiturate solutions).

  Studies have shown that cisatracurium besylate injection is compatible with:

  • 5% Dextrose injection, USP • 0.9% Sodium chloride injection, USP • 5% Dextrose and 0.9% Sodium chloride injection, USP • SUFENTA ® (sufentanil citrate) injection, diluted as directed • ALFENTA ® (alfentanil hydrochloride) injection, diluted as directed • SUBLIMAZE ® (fentanyl citrate) injection, diluted as directed • VERSED ® (midazolam hydrochloride) injection, diluted as directed • Droperidol injection, diluted as directed

  Cisatracurium besylate injection is not compatible with DIPRIVAN® (propofol) injection or TORADOL® (ketorolac) injection for Y-site administration. Studies of other parenteral products have not been conducted.

  Dilution Stability

  Cisatracurium besylate injection diluted in 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or 5% Dextrose and 0.9% Sodium Chloride Injection, USP to 0.1 mg/mL may be stored either under refrigeration or at room temperature for 24 hours without significant loss of potency. Dilutions to 0.1 mg/mL or 0.2 mg/mL in 5% Dextrose and Lactated Ringer's Injection may be stored under refrigeration for 24 hours.

  Cisatracurium besylate injection should not be diluted in Lactated Ringer's Injection, USP due to chemical instability.

  NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are not clear, or contain visible particulates, should not be used. Cisatracurium besylate injection is a colorless to slightly yellow or greenish-yellow solution.

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  No Recall

  More Info
• Sandoz Inc
  

  ×

  Cisatracurium Besylate | Sandoz Inc

  

  ---

  NOTE: CONTAINS BENZYL ALCOHOL (see WARNINGS and PRECAUTIONS: Pediatric Use)

  CISATRACURIUM BESYLATE INJECTION SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY.

  The dosage information provided below is intended as a guide only. Doses of cisatracuriumbesylate injection should be individualized (see CLINICAL PHARMACOLOGY- Individualization of Dosages). The use of a peripheral nerve stimulator will permit the most advantageous use of cisatracuriumbesylate injection, minimize the possibility of overdosage or underdosage, and assist in the evaluation of recovery.

  Adults Initial Doses

  One of two intubating doses of cisatracurium besylate may be chosen, based on the desired time to tracheal intubation and the anticipated length of surgery. In addition to the dose of neuromuscular blocking agent, the presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia are factors that can influence intubation conditions. Doses of 0.15 (3 × ED95) and 0.20 (4 × ED95) mg/kg cisatracurium besylate, as components of a propofol/nitrous oxide/oxygen induction-intubation technique, may produce generally GOOD or EXCELLENT conditions for intubation in 2 and 1.5 minutes, respectively. Similar intubation conditions may be expected when these doses of cisatracurium besylate injection are administered as components of a thiopental/nitrous oxide/oxygen induction-intubation technique. In two intubation studies using thiopental or propofol and midazolam and fentanyl as co-induction agents, EXCELLENT intubation conditions were most frequently achieved with the 0.2 mg/kg compared to 0.15 mg/kg dose of cisatracurium besylate injection. The clinically effective durations of action for 0.15 and 0.20 mg/kg cisatracurium besylate injection during propofol anesthesia are 55 minutes (range: 44 to 74 minutes) and 61 minutes (range: 41 to 81 minutes), respectively. Lower doses may result in a longer time for the development of satisfactory intubation conditions. Doses up to 8 × ED95 cisatracurium besylate injection have been safely administered to healthy adult patients and patients with serious cardiovascular disease. These larger doses are associated with longer clinically effective durations of action (see CLINICAL PHARMACOLOGY).

  Because slower times to onset of complete neuromuscular block were observed in elderly patients and patients with renal dysfunction, extending the interval between administration of cisatracurium besylate injection and the intubation attempt for these patients may be required to achieve adequate intubation conditions.

  A dose of 0.03 mg/kg cisatracurium besylate injection is recommended for maintenance of neuromuscular block during prolonged surgical procedures. Maintenance doses of 0.03 mg/kg each sustain neuromuscular block for approximately 20 minutes. Maintenance dosing is generally required 40 to 50 minutes following an initial dose of 0.15 mg/kg cisatracurium besylate injection and 50 to 60 minutes following an initial dose of 0.20 mg/kg cisatracurium besylate injection, but the need for maintenance doses should be determined by clinical criteria. For shorter or longer durations of action, smaller or larger maintenance doses may be administered.

  Isoflurane or enflurane administered with nitrous oxide/oxygen to achieve 1.25 MAC (Minimum Alveolar Concentration) may prolong the clinically effective duration of action of initial and maintenance doses. The magnitude of these effects may depend on the duration of administration of the volatile agents. Fifteen to 30 minutes of exposure to 1.25 MAC isoflurane or enflurane had minimal effects on the duration of action of initial doses of cisatracurium besylate injection and therefore, no adjustment to the initial dose should be necessary when cisatracurium besylate injection is administered shortly after initiation of volatile agents. In long surgical procedures during enflurane or isoflurane anesthesia, less frequent maintenance dosing or lower maintenance doses of cisatracurium besylate injection may be necessary. No adjustments to the initial dose of cisatracurium besylate injection are required when used in patients receiving propofol anesthesia.

  Children Initial Doses

  The recommended dose of cisatracurium besylate injection for children 2 to 12 years of age is 0.10 to 0.15 mg/kg administered over 5 to 10 seconds during either halothane or opioid anesthesia. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.10 mg/kg cisatracurium besylate injection produces maximum neuromuscular block in an average of 2.8 minutes (range: 1.8 to 6.7 minutes) and clinically effective block for 28 minutes (range: 21 to 38 minutes). When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate produces maximum neuromuscular block in about 3 minutes (range: 1.5 to 8 minutes) and clinically effective block (time to 25% recovery) for 36 minutes (range:  29 to 46 minutes).

  Infants Initial Doses

  The recommended dose of cisatracurium besylate injection for intubation of infants 1 month to 23 months is 0.15 mg/kg administered over 5 to 10 seconds during either halothane or opioid anesthesia. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate produces maximum neuromuscular block in about 2 minutes (range: 1.3 to 3.4 minutes) and clinically effective block (time to 25% recovery) for about 43 minutes (range: 34 to 58 minutes).

  Use by Continuous Infusion Infusion in the Operating Room (OR)

  After administration of an initial bolus dose of cisatracurium besylate injection, a diluted solution of cisatracurium besylate can be administered by continuous infusion to adults and children aged 2 or more years for maintenance of neuromuscular block during extended surgical procedures. Infusion of cisatracurium besylate injection should be individualized for each patient. The rate of administration should be adjusted according to the patient's response as determined by peripheral nerve stimulation. Accurate dosing is best achieved using a precision infusion device.

  Infusion of cisatracurium besylate injection should be initiated only after early evidence of spontaneous recovery from the initial bolus dose. An initial infusion rate of 3 mcg/kg/min may be required to rapidly counteract the spontaneous recovery of neuromuscular function. Thereafter, a rate of 1 to 2 mcg/kg/min should be adequate to maintain continuous neuromuscular block in the range of 89% to 99% in most pediatric and adult patients under opioid/nitrous oxide/oxygen anesthesia.

  Reduction of the infusion rate by up to 30% to 40% should be considered when cisatracurium besylate injection is administered during stable isoflurane or enflurane anesthesia (administered with nitrous oxide/oxygen at the 1.25 MAC level). Greater reductions in the infusion rate of cisatracurium besylate injection may be required with longer durations of administration of isoflurane or enflurane.

  The rate of infusion of atracurium required to maintain adequate surgical relaxation in patients undergoing coronary artery bypass surgery with induced hypothermia (25° to 28°C) is approximately half the rate required during normothermia. Based on the structural similarity between cisatracurium besylate injection and atracurium, a similar effect on the infusion rate of cisatracurium besylate injection may be expected.

  Spontaneous recovery from neuromuscular block following discontinuation of infusion of cisatracurium besylate may be expected to proceed at a rate comparable to that following administration of a single bolus dose.

  Infusion in the Intensive Care Unit (ICU)

  The principles for infusion of cisatracurium besylate injection in the OR are also applicable to use in the ICU. An infusion rate of approximately 3 mcg/kg/min (range: 0.5 to 10.2 mcg/kg/min) should provide adequate neuromuscular block in adult patients in the ICU. There may be wide interpatient variability in dosage requirements and these may increase or decrease with time (see PRECAUTIONS - Long-Term Use in the Intensive Care Unit (ICU)). Following recovery from neuromuscular block, readministration of a bolus dose may be necessary to quickly re-establish neuromuscular block prior to reinstitution of the infusion.

  Infusion Rate Tables

  The amount of infusion solution required per minute will depend upon the concentration of cisatracurium besylate in the infusion solution, the desired dose of cisatracurium besylate, and the patient's weight. The contribution of the infusion solution to the fluid requirements of the patient also must be considered. Tables 10 and 11 provide guidelines for delivery, in mL/hr (equivalent to microdrops/minute when 60 microdrops = 1 mL), of cisatracurium besylate solutions in concentrations of 0.1 mg/mL (10 mg/100 mL) or 0.4 mg/mL (40 mg/100 mL).

  Table 10. Infusion Rates of Cisatracurium Besylate for Maintenance of Neuromuscular Block During Opioid/Nitrous Oxide/Oxygen Anesthesia for a Concentration of 0.1 mg/mL Drug Delivery Rate (mcg/kg/min)

  1

  1.5

  2

  3

  5

  Patient Weight (kg)

  Infusion Delivery Rate (mL/hr)

  10

  6

  9

  12

  18

  30

  45

  27

  41

  54

  81

  135

  70

  42

  63

  84

  126

  210

  100

  60

  90

  120

  180

  300

  Table 11. Infusion Rates of Cisatracurium Besylate for Maintenance of Neuromuscular Block During Opioid/Nitrous Oxide/Oxygen Anesthesia for a Concentration of 0.4 mg/mL Drug Delivery Rate (mcg/kg/min)

  1

  1.5

  2

  3

  5

  Patient Weight (kg)

  Infusion Delivery Rate (mL/hr)

  10

  1.5

  2.3

  3

  4.5

  7.5

  45

  6.8

  10.1

  13.5

  20.3

  33.8

  70

  10.5

  15.8

  21

  31.5

  52.5

  100

  15

  22.5

  30

  45

  75

  Cisatracurium Besylate Injection Compatibility and Admixtures Y-site Administration

  Cisatracurium besylate injection is acidic (pH = 3.25 to 3.65) and may not be compatible with alkaline solution having a pH greater than 8.5 (e.g., barbiturate solutions).

  Studies have shown that cisatracurium besylate injection is compatible with:

  • 5% Dextrose injection, USP • 0.9% Sodium chloride injection, USP • 5% Dextrose and 0.9% sodium chloride injection, USP • SUFENTA ® (sufentanil citrate) injection, diluted as directed • ALFENTA ® (alfentanil hydrochloride) injection, diluted as directed • SUBLIMAZE ® (fentanyl citrate) injection, diluted as directed • VERSED ® (midazolam hydrochloride) injection, diluted as directed • Droperidol injection, diluted as directed

  Cisatracurium besylate injection is not compatible with DIPRIVAN® (propofol) injection or TORADOL® (ketorolac) injection for Y-site administration. Studies of other parenteral products have not been conducted.

  Dilution Stability

  Cisatracurium besylate injection diluted in 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or 5% Dextrose and 0.9% Sodium Chloride Injection, USP to 0.1 mg/mL may be stored either under refrigeration or at room temperature for 24 hours without significant loss of potency. Dilutions to 0.1 mg/mL or 0.2 mg/mL in 5% Dextrose and Lactated Ringer's Injection may be stored under refrigeration for 24 hours.

  Cisatracurium besylate injection should not be diluted in Lactated Ringer's Injection, USP due to chemical instability.

  NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are not clear, or contain visible particulates, should not be used. Cisatracurium besylate injection is a colorless to slightly yellow or greenish-yellow solution.

  Close
  No Recall

  More Info
• Sandoz Inc
  

  ×

  Cisatracurium Besylate | Sandoz Inc

  

  ---

  NOTE: CONTAINS BENZYL ALCOHOL (see WARNINGS and PRECAUTIONS: Pediatric Use)

  CISATRACURIUM BESYLATE INJECTION SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY.

  The dosage information provided below is intended as a guide only. Doses of cisatracuriumbesylate injection should be individualized (see CLINICAL PHARMACOLOGY- Individualization of Dosages). The use of a peripheral nerve stimulator will permit the most advantageous use of cisatracuriumbesylate injection, minimize the possibility of overdosage or underdosage, and assist in the evaluation of recovery.

  Adults

  Initial Doses

  One of two intubating doses of cisatracurium besylate may be chosen, based on the desired time to tracheal intubation and the anticipated length of surgery. In addition to the dose of neuromuscular blocking agent, the presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia are factors that can influence intubation conditions. Doses of 0.15 (3 × ED95) and 0.20 (4 × ED95) mg/kg cisatracurium besylate, as components of a propofol/nitrous oxide/oxygen induction-intubation technique, may produce generally GOOD or EXCELLENT conditions for intubation in 2 and 1.5 minutes, respectively. Similar intubation conditions may be expected when these doses of cisatracurium besylate injection are administered as components of a thiopental/nitrous oxide/oxygen induction-intubation technique. In two intubation studies using thiopental or propofol and midazolam and fentanyl as co-induction agents, EXCELLENT intubation conditions were most frequently achieved with the 0.2 mg/kg compared to 0.15 mg/kg dose of cisatracurium besylate injection. The clinically effective durations of action for 0.15 and 0.20 mg/kg cisatracurium besylate injection during propofol anesthesia are 55 minutes (range: 44 to 74 minutes) and 61 minutes (range: 41 to 81 minutes), respectively. Lower doses may result in a longer time for the development of satisfactory intubation conditions. Doses up to 8 × ED95 cisatracurium besylate injection have been safely administered to healthy adult patients and patients with serious cardiovascular disease. These larger doses are associated with longer clinically effective durations of action (see CLINICAL PHARMACOLOGY).

  Because slower times to onset of complete neuromuscular block were observed in elderly patients and patients with renal dysfunction, extending the interval between administration of cisatracurium besylate injection and the intubation attempt for these patients may be required to achieve adequate intubation conditions.

  A dose of 0.03 mg/kg cisatracurium besylate injection is recommended for maintenance of neuromuscular block during prolonged surgical procedures. Maintenance doses of 0.03 mg/kg each sustain neuromuscular block for approximately 20 minutes. Maintenance dosing is generally required 40 to 50 minutes following an initial dose of 0.15 mg/kg cisatracurium besylate injection and 50 to 60 minutes following an initial dose of 0.20 mg/kg cisatracurium besylate injection, but the need for maintenance doses should be determined by clinical criteria. For shorter or longer durations of action, smaller or larger maintenance doses may be administered.

  Isoflurane or enflurane administered with nitrous oxide/oxygen to achieve 1.25 MAC (Minimum Alveolar Concentration) may prolong the clinically effective duration of action of initial and maintenance doses. The magnitude of these effects may depend on the duration of administration of the volatile agents. Fifteen to 30 minutes of exposure to 1.25 MAC isoflurane or enflurane had minimal effects on the duration of action of initial doses of cisatracurium besylate injection and therefore, no adjustment to the initial dose should be necessary when cisatracurium besylate injection is administered shortly after initiation of volatile agents. In long surgical procedures during enflurane or isoflurane anesthesia, less frequent maintenance dosing or lower maintenance doses of cisatracurium besylate injection may be necessary. No adjustments to the initial dose of cisatracurium besylate injection are required when used in patients receiving propofol anesthesia.

  Children

  Initial Doses

  The recommended dose of cisatracurium besylate injection for children 2 to 12 years of age is 0.10 to 0.15 mg/kg administered over 5 to 10 seconds during either halothane or opioid anesthesia. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.10 mg/kg cisatracurium besylate injection produces maximum neuromuscular block in an average of 2.8 minutes (range: 1.8 to 6.7 minutes) and clinically effective block for 28 minutes (range: 21 to 38 minutes). When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate produces maximum neuromuscular block in about 3 minutes (range: 1.5 to 8 minutes) and clinically effective block (time to 25% recovery) for 36 minutes (range:  29 to 46 minutes).

  Infants

  Initial Doses

  The recommended dose of cisatracurium besylate injection for intubation of infants 1 month to 23 months is 0.15 mg/kg administered over 5 to 10 seconds during either halothane or opioid anesthesia. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate produces maximum neuromuscular block in about 2 minutes (range: 1.3 to 3.4 minutes) and clinically effective block (time to 25% recovery) for about 43 minutes (range: 34 to 58 minutes).

  Use by Continuous Infusion

  Infusion in the Operating Room (OR)

  After administration of an initial bolus dose of cisatracurium besylate injection, a diluted solution of cisatracurium besylate can be administered by continuous infusion to adults and children aged 2 or more years for maintenance of neuromuscular block during extended surgical procedures. Infusion of cisatracurium besylate injection should be individualized for each patient. The rate of administration should be adjusted according to the patient's response as determined by peripheral nerve stimulation. Accurate dosing is best achieved using a precision infusion device.

  Infusion of cisatracurium besylate injection should be initiated only after early evidence of spontaneous recovery from the initial bolus dose. An initial infusion rate of 3 mcg/kg/min may be required to rapidly counteract the spontaneous recovery of neuromuscular function. Thereafter, a rate of 1 to 2 mcg/kg/min should be adequate to maintain continuous neuromuscular block in the range of 89% to 99% in most pediatric and adult patients under opioid/nitrous oxide/oxygen anesthesia.

  Reduction of the infusion rate by up to 30% to 40% should be considered when cisatracurium besylate injection is administered during stable isoflurane or enflurane anesthesia (administered with nitrous oxide/oxygen at the 1.25 MAC level). Greater reductions in the infusion rate of cisatracurium besylate injection may be required with longer durations of administration of isoflurane or enflurane.

  The rate of infusion of atracurium required to maintain adequate surgical relaxation in patients undergoing coronary artery bypass surgery with induced hypothermia (25° to 28°C) is approximately half the rate required during normothermia. Based on the structural similarity between cisatracurium besylate injection and atracurium, a similar effect on the infusion rate of cisatracurium besylate injection may be expected.

  Spontaneous recovery from neuromuscular block following discontinuation of infusion of cisatracurium besylate may be expected to proceed at a rate comparable to that following administration of a single bolus dose.

  Infusion in the Intensive Care Unit (ICU)

  The principles for infusion of cisatracurium besylate injection in the OR are also applicable to use in the ICU. An infusion rate of approximately 3 mcg/kg/min (range: 0.5 to 10.2 mcg/kg/min) should provide adequate neuromuscular block in adult patients in the ICU. There may be wide interpatient variability in dosage requirements and these may increase or decrease with time (see PRECAUTIONS - Long-Term Use in the Intensive Care Unit (ICU)). Following recovery from neuromuscular block, readministration of a bolus dose may be necessary to quickly re-establish neuromuscular block prior to reinstitution of the infusion.

  Infusion Rate Tables

  The amount of infusion solution required per minute will depend upon the concentration of cisatracurium besylate in the infusion solution, the desired dose of cisatracurium besylate, and the patient's weight. The contribution of the infusion solution to the fluid requirements of the patient also must be considered. Tables 10 and 11 provide guidelines for delivery, in mL/hr (equivalent to microdrops/minute when 60 microdrops = 1 mL), of cisatracurium besylate solutions in concentrations of 0.1 mg/mL (10 mg/100 mL) or 0.4 mg/mL (40 mg/100 mL).

  Table 10. Infusion Rates of Cisatracurium Besylate for Maintenance of Neuromuscular Block During Opioid/Nitrous Oxide/Oxygen Anesthesia for a Concentration of 0.1 mg/mL Drug Delivery Rate (mcg/kg/min)

  1

  1.5

  2

  3

  5

  Patient Weight (kg)

  Infusion Delivery Rate (mL/hr)

  10

  6

  9

  12

  18

  30

  45

  27

  41

  54

  81

  135

  70

  42

  63

  84

  126

  210

  100

  60

  90

  120

  180

  300

  Table 11. Infusion Rates of Cisatracurium Besylate for Maintenance of Neuromuscular Block During Opioid/Nitrous Oxide/Oxygen Anesthesia for a Concentration of 0.4 mg/mL Drug Delivery Rate (mcg/kg/min)

  1

  1.5

  2

  3

  5

  Patient Weight (kg)

  Infusion Delivery Rate (mL/hr)

  10

  1.5

  2.3

  3

  4.5

  7.5

  45

  6.8

  10.1

  13.5

  20.3

  33.8

  70

  10.5

  15.8

  21

  31.5

  52.5

  100

  15

  22.5

  30

  45

  75

  Cisatracurium Besylate Injection Compatibility and Admixtures

  Y-site Administration

  Cisatracurium besylate injection is acidic (pH = 3.25 to 3.65) and may not be compatible with alkaline solution having a pH greater than 8.5 (e.g., barbiturate solutions).

  Studies have shown that cisatracurium besylate injection is compatible with:

  • 5% Dextrose injection, USP • 0.9% Sodium chloride injection, USP • 5% Dextrose and 0.9% sodium chloride injection, USP • SUFENTA ® (sufentanil citrate) injection, diluted as directed • ALFENTA ® (alfentanil hydrochloride) injection, diluted as directed • SUBLIMAZE ® (fentanyl citrate) injection, diluted as directed • VERSED ® (midazolam hydrochloride) injection, diluted as directed • Droperidol injection, diluted as directed

  Cisatracurium besylate injection is not compatible with DIPRIVAN® (propofol) injection or TORADOL® (ketorolac) injection for Y-site administration. Studies of other parenteral products have not been conducted.

  Dilution Stability

  Cisatracurium besylate injection diluted in 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or 5% Dextrose and 0.9% Sodium Chloride Injection, USP to 0.1 mg/mL may be stored either under refrigeration or at room temperature for 24 hours without significant loss of potency. Dilutions to 0.1 mg/mL or 0.2 mg/mL in 5% Dextrose and Lactated Ringer's Injection may be stored under refrigeration for 24 hours.

  Cisatracurium besylate injection should not be diluted in Lactated Ringer's Injection, USP due to chemical instability.

  NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are not clear, or contain visible particulates, should not be used. Cisatracurium besylate injection is a colorless to slightly yellow or greenish-yellow solution

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  Cisatracurium Besylate | Sandoz Inc

  

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  CISATRACURIUM BESYLATE INJECTION SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY.

  The dosage information provided below is intended as a guide only. Doses of cisatracuriumbesylate injection should be individualized (see CLINICAL PHARMACOLOGY- Individualization of Dosages). The use of a peripheral nerve stimulator will permit the most advantageous use of cisatracuriumbesylate injection, minimize the possibility of overdosage or underdosage, and assist in the evaluation of recovery.

  Adults Initial Doses

  One of two intubating doses of cisatracurium besylate may be chosen, based on the desired time to tracheal intubation and the anticipated length of surgery. In addition to the dose of neuromuscular blocking agent, the presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia are factors that can influence intubation conditions. Doses of 0.15 (3 × ED95) and 0.20 (4 × ED95) mg/kg cisatracurium besylate, as components of a propofol/nitrous oxide/oxygen induction-intubation technique, may produce generally GOOD or EXCELLENT conditions for intubation in 2 and 1.5 minutes, respectively. Similar intubation conditions may be expected when these doses of cisatracurium besylate injection are administered as components of a thiopental/nitrous oxide/oxygen induction-intubation technique. In two intubation studies using thiopental or propofol and midazolam and fentanyl as co-induction agents, EXCELLENT intubation conditions were most frequently achieved with the 0.2 mg/kg compared to 0.15 mg/kg dose of cisatracurium besylate injection. The clinically effective durations of action for 0.15 and 0.20 mg/kg cisatracurium besylate injection during propofol anesthesia are 55 minutes (range: 44 to 74 minutes) and 61 minutes (range: 41 to 81 minutes), respectively. Lower doses may result in a longer time for the development of satisfactory intubation conditions. Doses up to 8 × ED95 cisatracurium besylate injection have been safely administered to healthy adult patients and patients with serious cardiovascular disease. These larger doses are associated with longer clinically effective durations of action (see CLINICAL PHARMACOLOGY).

  Because slower times to onset of complete neuromuscular block were observed in elderly patients and patients with renal dysfunction, extending the interval between administration of cisatracurium besylate injection and the intubation attempt for these patients may be required to achieve adequate intubation conditions.

  A dose of 0.03 mg/kg cisatracurium besylate injection is recommended for maintenance of neuromuscular block during prolonged surgical procedures. Maintenance doses of 0.03 mg/kg each sustain neuromuscular block for approximately 20 minutes. Maintenance dosing is generally required 40 to 50 minutes following an initial dose of 0.15 mg/kg cisatracurium besylate and 50 to 60 minutes following an initial dose of 0.20 mg/kg cisatracurium besylate, but the need for maintenance doses should be determined by clinical criteria. For shorter or longer durations of action, smaller or larger maintenance doses may be administered.

  Isoflurane or enflurane administered with nitrous oxide/oxygen to achieve 1.25 MAC (Minimum Alveolar Concentration) may prolong the clinically effective duration of action of initial and maintenance doses. The magnitude of these effects may depend on the duration of administration of the volatile agents. Fifteen to 30 minutes of exposure to 1.25 MAC isoflurane or enflurane had minimal effects on the duration of action of initial doses of cisatracurium besylate injection and therefore, no adjustment to the initial dose should be necessary when cisatracurium besylate injection is administered shortly after initiation of volatile agents. In long surgical procedures during enflurane or isoflurane anesthesia, less frequent maintenance dosing or lower maintenance doses of cisatracurium besylate injection may be necessary. No adjustments to the initial dose of cisatracurium besylate injection are required when used in patients receiving propofol anesthesia.

  Children Initial Doses

  The recommended dose of cisatracurium besylate injection for children 2 to 12 years of age is 0.10-0.15 mg/kg administered over 5 to 10 seconds during either halothane or opioid anesthesia. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.10 mg/kg cisatracurium besylate injection produces maximum neuromuscular block in an average of 2.8 minutes (range: 1.8 to 6.7 minutes) and clinically effective block for 28 minutes (range: 21 to 38 minutes). When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate produces maximum neuromuscular block in about 3 minutes (range: 1.5 to 8 minutes) and clinically effective block (time to 25% recovery) for 36 minutes (range:  29 to 46 minutes).

  Infants Initial Doses

  The recommended dose of cisatracurium besylate injection for intubation of infants 1 month to 23 months is 0.15 mg/kg administered over 5 to 10 seconds during either halothane or opioid anesthesia. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate produces maximum neuromuscular block in about 2 minutes (range: 1.3 to 3.4 minutes) and clinically effective block (time to 25% recovery) for about 43 minutes (range: 34 to 58 minutes).

  Use by Continuous Infusion Infusion in the Operating Room (OR)

  After administration of an initial bolus dose of cisatracurium besylate, a diluted solution of cisatracurium besylate injection can be administered by continuous infusion to adults and children aged 2 or more years for maintenance of neuromuscular block during extended surgical procedures. Infusion of cisatracurium besylate injection should be individualized for each patient. The rate of administration should be adjusted according to the patient's response as determined by peripheral nerve stimulation. Accurate dosing is best achieved using a precision infusion device.

  Infusion of cisatracurium besylate injection should be initiated only after early evidence of spontaneous recovery from the initial bolus dose. An initial infusion rate of 3 mcg/kg/min may be required to rapidly counteract the spontaneous recovery of neuromuscular function. Thereafter, a rate of 1 to 2 mcg/kg/min should be adequate to maintain continuous neuromuscular block in the range of 89% to 99% in most pediatric and adult patients under opioid/nitrous oxide/oxygen anesthesia.

  Reduction of the infusion rate by up to 30% to 40% should be considered when cisatracurium besylate injection is administered during stable isoflurane or enflurane anesthesia (administered with nitrous oxide/oxygen at the 1.25 MAC level). Greater reductions in the infusion rate of cisatracurium besylate injection may be required with longer durations of administration of isoflurane or enflurane.

  The rate of infusion of atracurium required to maintain adequate surgical relaxation in patients undergoing coronary artery bypass surgery with induced hypothermia (25° to 28°C) is approximately half the rate required during normothermia. Based on the structural similarity between cisatracurium besylate injection and atracurium, a similar effect on the infusion rate of cisatracurium besylate injection may be expected.

  Spontaneous recovery from neuromuscular block following discontinuation of infusion of cisatracurium besylate may be expected to proceed at a rate comparable to that following administration of a single bolus dose.

  Infusion in the Intensive Care Unit (ICU)

  The principles for infusion of cisatracurium besylate injection in the OR are also applicable to use in the ICU. An infusion rate of approximately 3 mcg/kg/min (range: 0.5 to 10.2 mcg/kg/min) should provide adequate neuromuscular block in adult patients in the ICU. There may be wide interpatient variability in dosage requirements and these may increase or decrease with time (see PRECAUTIONS - Long-Term Use in the Intensive Care Unit (ICU)). Following recovery from neuromuscular block, readministration of a bolus dose may be necessary to quickly re-establish neuromuscular block prior to reinstitution of the infusion.

  Infusion Rate Tables

  The amount of infusion solution required per minute will depend upon the concentration of cisatracurium besylate in the infusion solution, the desired dose of cisatracurium besylate, and the patient's weight. The contribution of the infusion solution to the fluid requirements of the patient also must be considered. Tables 10 and 11 provide guidelines for delivery, in mL/hr (equivalent to microdrops/minute when 60 microdrops = 1 mL), of cisatracurium besylate solutions in concentrations of 0.1 mg/mL (10 mg/100 mL) or 0.4 mg/mL (40 mg/100 mL).

  Table 10. Infusion Rates of Cisatracurium Besylate for Maintenance of Neuromuscular Block During Opioid/Nitrous Oxide/Oxygen Anesthesia for a Concentration of 0.1 mg/mL Drug Delivery Rate (mcg/kg/min)

  1

  1.5

  2

  3

  5

  Patient Weight (kg)

  Infusion Delivery Rate (mL/hr)

  10

  6

  9

  12

  18

  30

  45

  27

  41

  54

  81

  135

  70

  42

  63

  84

  126

  210

  100

  60

  90

  120

  180

  300

  Table 11. Infusion Rates of Cisatracurium Besylate for Maintenance of Neuromuscular Block During Opioid/Nitrous Oxide/Oxygen Anesthesia for a Concentration of 0.4 mg/mL Drug Delivery Rate (mcg/kg/min)

  1

  1.5

  2

  3

  5

  Patient Weight (kg)

  Infusion Delivery Rate (mL/hr)

  10

  1.5

  2.3

  3

  4.5

  7.5

  45

  6.8

  10.1

  13.5

  20.3

  33.8

  70

  10.5

  15.8

  21

  31.5

  52.5

  100

  15

  22.5

  30

  45

  75

  Cisatracurium Besylate Injection Compatibility and Admixtures Y-site Administration

  Cisatracurium besylate injection is acidic (pH = 3.25 to 3.65) and may not be compatible with alkaline solution having a pH greater than 8.5 (e.g., barbiturate solutions).

  Studies have shown that cisatracurium besylate injection is compatible with:

  • 5% Dextrose injection, USP • 0.9% Sodium chloride injection, USP • 5% Dextrose and 0.9% Sodium chloride injection, USP • SUFENTA ® (sufentanil citrate) injection, diluted as directed • ALFENTA ® (alfentanil hydrochloride) injection, diluted as directed • SUBLIMAZE ® (fentanyl citrate) injection, diluted as directed • VERSED ® (midazolam hydrochloride) injection, diluted as directed • Droperidol injection, diluted as directed

  Cisatracurium besylate injection is not compatible with DIPRIVAN® (propofol) injection or TORADOL® (ketorolac) injection for Y-site administration. Studies of other parenteral products have not been conducted.

  Dilution Stability

  Cisatracurium besylate injection diluted in 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or 5% Dextrose and 0.9% Sodium Chloride Injection, USP to 0.1 mg/mL may be stored either under refrigeration or at room temperature for 24 hours without significant loss of potency. Dilutions to 0.1 mg/mL or 0.2 mg/mL in 5% Dextrose and Lactated Ringer's Injection may be stored under refrigeration for 24 hours.

  Cisatracurium besylate injection should not be diluted in Lactated Ringer's Injection, USP due to chemical instability.

  NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Solutions which are not clear, or contain visible particulates, should not be used. Cisatracurium besylate injection is a colorless to slightly yellow or greenish-yellow solution.

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