Cisatracurium Besylate (Page 2 of 9)

2.6 Rate Tables for Continuous Infusion

The intravenous infusion rate depends upon the cisatracurium besylate injection concentration, the desired dose, the patient’s weight, and the contribution of the infusion solution to the fluid requirements of the patient. Tables 1 and 2 provide guidelines for the cisatracurium besylate injection infusion rate, in mL/hour (equivalent to microdrops/minute when 60 microdrops = 1 mL), in concentrations of 0.1 mg per mL or 0.4 mg per mL, respectively.

Table 1. Cisatracurium Besylate Injection Infusion Rates for Maintenance of Neuromuscular Blockade During Opioid/Nitrous Oxide/Oxygen Anesthesia with a Concentration of 0.1 mg per mL
Drug Delivery Rate (mcg/kg/minute)
1 1.5 2 3 5
Patient Weight Infusion Delivery Rate (mL/hour)
10 kg 6 9 12 18 30
45 kg 27 41 54 81 135
70 kg 42 63 84 126 210
100 kg 60 90 120 180 300
Table 2. Cisatracurium Besylate Injection Infusion Rates for Maintenance of Neuromuscular Blockade During Opioid/Nitrous Oxide/Oxygen Anesthesia with a Concentration of 0.4 mg per mL
Drug Delivery Rate (mcg/kg/minute)
1 1.5 2 3 5
Patient Weight Infusion Delivery Rate (mL/hour)
10 kg 1.5 2.3 3 4.5 7.5
45 kg 6.8 10.1 13.5 20.3 33.8
70 kg 10.5 15.8 21 31.5 52.5
100 kg 15 22.5 30 45 75

2.7 Preparation of Cisatracurium Besylate Injection

Visually inspect cisatracurium besylate injection for particulate matter and discoloration prior to administration. If a cisatracurium besylate injection solution is cloudy or contains visible particulates, do not use cisatracurium besylate injection. Cisatracurium besylate injection is a colorless to slightly yellow or greenish-yellow solution.

Cisatracurium besylate injection may be diluted to 0.1 mg per mL in the following solutions:

  • 5% Dextrose Injection, USP
  • 0.9% Sodium Chloride Injection, USP, or
  • 5% Dextrose and 0.9% Sodium Chloride Injection, USP

Store these diluted cisatracurium besylate injection solutions either in a refrigerator or at room temperature for 24 hours without significant loss of potency.

Cisatracurium besylate injection also may be diluted to 0.1 mg per mL or 0.2 mg per mL in the following solution:

  • Lactated Ringer’s and 5% Dextrose Injection

Store this diluted cisatracurium besylate injection solution under refrigeration for no more than 24 hours.

Do not dilute cisatracurium besylate injection in Lactated Ringer’s Injection, USP due to chemical instability.

2.8 Drug Compatibility

Cisatracurium besylate injection is compatible and may be administered with the following solutions through Y-site administration:

  • 5% Dextrose Injection, USP
  • 0.9% Sodium Chloride Injection, USP
  • 5% Dextrose and 0.9% Sodium Chloride Injection, USP
  • Sufentanil Citrate Injection, diluted as directed
  • Alfentanil Hydrochloride Injection, diluted as directed
  • Fentanyl Citrate Injection, diluted as directed
  • Midazolam Hydrochloride Injection, diluted as directed
  • Droperidol Injection, diluted as directed

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). Therefore, do not administer cisatracurium besylate injection and alkaline solutions simultaneously in the same intravenous line.

Cisatracurium besylate injection is not compatible with propofol injection or ketorolac injection for Y-site administration. Compatibility studies with other parenteral products have not been conducted.

3 DOSAGE FORMS AND STRENGTHS

Cisatracurium Besylate Injection, USP is available as a clear solution in the following strengths:

  • 10 mg of cisatracurium per 5 mL (2 mg per mL) in single-dose vials (equivalent to 2.68 mg per mL cisatracurium besylate)
  • 20 mg of cisatracurium per 10 mL (2 mg per mL) and benzyl alcohol as a preservative in multiple-dose vials (equivalent to 2.68 mg per mL cisatracurium besylate).
  • 200 mg of cisatracurium per 20 mL (10 mg per mL) in single-dose vials (equivalent to 13.38 mg per mL cisatracurium besylate); intended only for administration as an infusion in a single patient in the ICU.

4 CONTRAINDICATIONS

Cisatracurium besylate is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to cisatracurium besylate have been reported [see Warnings and Precautions (5.4)].

The use of 10 mL cisatracurium besylate multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains benzyl alcohol [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4)].

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