Cisatracurium Besylate - Cisatracurium Besylate injection
(Cisatracurium Besylate)Cisatracurium Besylate - Cisatracurium Besylate injection Prescribing Information
Cisatracurium Besylate injection is indicated:
• as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age
• to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU
• to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older.
Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
Store Cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product (
- Determine the adequacy of neuromuscular blockade (e.g., need for additional cisatracurium besylate injection doses, reduction of the infusion rate).
- Minimize risk of overdosage or underdosage.
- Assess the extent of recovery from neuromuscular blockade (e.g., spontaneous recovery or recovery after administration of a reversal agent, e.g., neostigmine).
- Appropriately titrate doses to potentially limit exposure to toxic metabolites.
- Facilitate more rapid reversal of the cisatracurium besylate injection – induced paralysis.
• Administer intravenously only by or under the supervision of experienced clinicians familiar with drug’s actions and possible complications (
- Determine the adequacy of neuromuscular blockade (e.g., need for additional cisatracurium besylate injection doses, reduction of the infusion rate).
- Minimize risk of overdosage or underdosage.
- Assess the extent of recovery from neuromuscular blockade (e.g., spontaneous recovery or recovery after administration of a reversal agent, e.g., neostigmine).
- Appropriately titrate doses to potentially limit exposure to toxic metabolites.
- Facilitate more rapid reversal of the cisatracurium besylate injection – induced paralysis.
• Use only if personnel and facilities for resuscitation and life support, and a cisatracurium besylate antagonist are immediately available (
- Determine the adequacy of neuromuscular blockade (e.g., need for additional cisatracurium besylate injection doses, reduction of the infusion rate).
- Minimize risk of overdosage or underdosage.
- Assess the extent of recovery from neuromuscular blockade (e.g., spontaneous recovery or recovery after administration of a reversal agent, e.g., neostigmine).
- Appropriately titrate doses to potentially limit exposure to toxic metabolites.
- Facilitate more rapid reversal of the cisatracurium besylate injection – induced paralysis.
• Use a peripheral nerve stimulator to determine adequacy of blockade (e.g., need for additional doses), minimize risk of overdosage or underdosage, assess extent of recovery from blockade, potentially limit exposure to toxic metabolites through dose titration, and facilitate more rapid reversal of cisatracurium besylate -induced paralysis (
- Determine the adequacy of neuromuscular blockade (e.g., need for additional cisatracurium besylate injection doses, reduction of the infusion rate).
- Minimize risk of overdosage or underdosage.
- Assess the extent of recovery from neuromuscular blockade (e.g., spontaneous recovery or recovery after administration of a reversal agent, e.g., neostigmine).
- Appropriately titrate doses to potentially limit exposure to toxic metabolites.
- Facilitate more rapid reversal of the cisatracurium besylate injection – induced paralysis.
See the Full Prescribing Information for:
• Dosage and administration instructions in adults, pediatric patients, geriatric patients, patients with neuromuscular disease, burns, end-stage renal disease, and patients undergoing coronary artery bypass graft surgery with induced hypothermia (
Prior to selecting the initial cisatracurium besylate injection bolus dose, consider the desired time to tracheal intubation and the anticipated length of surgery, factors affecting time to onset of complete neuromuscular block such as age and renal function, and factors that may influence intubation conditions such as the presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia.
In conjunction with a propofol/nitrous oxide/oxygen induction-intubation technique or a thiopental/nitrous oxide/oxygen induction-intubation technique, the recommended starting weight-based dose of cisatracurium besylate Injection is between 0.15 mg/kg and 0.2 mg/kg administered by bolus intravenous injection. Doses up to 0.4 mg/kg have been safely administered by bolus intravenous injection to healthy patients and patients with serious cardiovascular disease
The maximum recommended initial bolus dose of cisatracurium besylate injection is 0.02 mg/kg in patients with neuromuscular diseases (e.g., myasthenia gravis and myasthenic syndrome and carcinomatosis)
Because the time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients compared to younger patients (and in patients with end-stage renal disease than in patients with normal renal function), consider extending the interval between administering cisatracurium besylate injection and attempting intubation by at least 1 minute to achieve adequate intubation conditions in geriatric patients and patients with end-stage renal disease. A peripheral nerve stimulator should be used to determine the adequacy of muscle relaxation for the purposes of intubation and the timing and amounts of subsequent doses
The recommended dose of cisatracurium besylate injection for intubation of pediatric patients ages 1 month to 23 months is 0.15 mg/kg administered over 5 to 10 seconds. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg of cisatracurium besylate injection produced maximum neuromuscular blockade in about 2 minutes (range: 1.3 to 4.3 minutes) with a clinically effective block (time to 25% recovery) for about 43 minutes (range: 34 to 58 minutes)
The recommended weight-based bolus dose of cisatracurium besylate injection for pediatric patients 2 to 12 years of age is 0.1 to 0.15 mg/kg administered over 5 to 10 seconds. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.1 mg/kg cisatracurium besylate injection produced maximum neuromuscular blockade in an average of 2.8 minutes (range: 1.8 to 6.7 minutes) with a clinically effective block (time to 25% recovery) for 28 minutes (range: 21 to 38 minutes). When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate injection produced maximum neuromuscular blockade in an average of about 3 minutes (range: 1.5 to 8 minutes) with a clinically effective block for 36 minutes (range: 29 to 46 minutes)
Determine if maintenance bolus doses are needed based on clinical criteria including the response to peripheral nerve stimulation. The recommended maintenance bolus dose of cisatracurium besylate injection is 0.03 mg/kg; however, smaller or larger maintenance doses may be administered based on the required duration of action. Administer the first maintenance bolus dose starting:
• 40 to 50 minutes after an initial dose of cisatracurium besylate injection 0.15 mg/kg;
• 50 to 60 minutes after an initial dose of cisatracurium besylate injection 0.2 mg/kg.
For long surgical procedures using inhalational anesthetics administered with nitrous oxide/oxygen at the 1.25 MAC level for at least 30 minutes, consider administering less frequent maintenance bolus doses or lower maintenance bolus doses of cisatracurium besylate injection
Burn patients have been shown to develop resistance to nondepolarizing neuromuscular blocking agents; therefore, consider increasing the cisatracurium besylate Injection dosages for intubation and maintenance
During extended surgical procedures, cisatracurium besylate injection may be administered by continuous infusion to adults and pediatric patients aged 2 or more years if patients have spontaneous recovery after the initial cisatracurium besylate injection bolus dose. Following recovery from neuromuscular blockade, it may be necessary to re-administer a bolus dose to quickly re-establish neuromuscular blockade prior to starting the continuous infusion.
If patients have had recovery of neuromuscular function, the recommended initial cisatracurium besylate injection infusion rate is 3 mcg/kg/minute
Consider reducing the infusion rate by up to 30% to 40% when cisatracurium besylate injection is administered during stable isoflurane anesthesia for at least 30 minutes (administered with nitrous oxide/oxygen at the 1.25 MAC level)
Consider reducing the infusion rate in patients undergoing CABG with induced hypothermia to half the rate required during normothermia
The recommended cisatracurium besylate injection infusion rate in adult patients in the ICU is 3 mcg/kg/minute (range: 0.5 to 10.2 mcg/kg/minute)
• Continuous infusion rates (
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/mL or 0.4 mg/mL, respectively.
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 |
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 |
• Preparation instructions (
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.
Discard unused portion of the 20 mL single-dose vials.
Cisatracurium besylate injection may be diluted to 0.1 mg/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/mL or 0.2 mg/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.
• 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.
Cisatracurium besylate injection USP is available as a colorless to slightly yellow or greenish-yellow solution in the following strength:
• 200 mg of cisatracurium per 20 mL (10 mg/mL) in single-dose vials.
•
Patients with hemiparesis or paraparesis may demonstrate resistance to nondepolarizing neuromuscular blocking agents in the affected limbs. To avoid inaccurate dosing, perform neuromuscular monitoring on a non-paretic limb.
• Cisatracurium besylate is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to cisatracurium besylate have been reported
Severe hypersensitivity reactions, including fatal and life-threatening anaphylactic reactions, have been reported
•
Prior to selecting the initial cisatracurium besylate injection bolus dose, consider the desired time to tracheal intubation and the anticipated length of surgery, factors affecting time to onset of complete neuromuscular block such as age and renal function, and factors that may influence intubation conditions such as the presence of co-induction agents (e.g., fentanyl and midazolam) and the depth of anesthesia.
In conjunction with a propofol/nitrous oxide/oxygen induction-intubation technique or a thiopental/nitrous oxide/oxygen induction-intubation technique, the recommended starting weight-based dose of cisatracurium besylate Injection is between 0.15 mg/kg and 0.2 mg/kg administered by bolus intravenous injection. Doses up to 0.4 mg/kg have been safely administered by bolus intravenous injection to healthy patients and patients with serious cardiovascular disease
The maximum recommended initial bolus dose of cisatracurium besylate injection is 0.02 mg/kg in patients with neuromuscular diseases (e.g., myasthenia gravis and myasthenic syndrome and carcinomatosis)
Because the time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients compared to younger patients (and in patients with end-stage renal disease than in patients with normal renal function), consider extending the interval between administering cisatracurium besylate injection and attempting intubation by at least 1 minute to achieve adequate intubation conditions in geriatric patients and patients with end-stage renal disease. A peripheral nerve stimulator should be used to determine the adequacy of muscle relaxation for the purposes of intubation and the timing and amounts of subsequent doses
The recommended dose of cisatracurium besylate injection for intubation of pediatric patients ages 1 month to 23 months is 0.15 mg/kg administered over 5 to 10 seconds. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg of cisatracurium besylate injection produced maximum neuromuscular blockade in about 2 minutes (range: 1.3 to 4.3 minutes) with a clinically effective block (time to 25% recovery) for about 43 minutes (range: 34 to 58 minutes)
The recommended weight-based bolus dose of cisatracurium besylate injection for pediatric patients 2 to 12 years of age is 0.1 to 0.15 mg/kg administered over 5 to 10 seconds. When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.1 mg/kg cisatracurium besylate injection produced maximum neuromuscular blockade in an average of 2.8 minutes (range: 1.8 to 6.7 minutes) with a clinically effective block (time to 25% recovery) for 28 minutes (range: 21 to 38 minutes). When administered during stable opioid/nitrous oxide/oxygen anesthesia, 0.15 mg/kg cisatracurium besylate injection produced maximum neuromuscular blockade in an average of about 3 minutes (range: 1.5 to 8 minutes) with a clinically effective block for 36 minutes (range: 29 to 46 minutes)
Cisatracurium besylate has been associated with residual paralysis. Patients with neuromuscular diseases (e.g., myasthenia gravis and myasthenic syndrome) and carcinomatosis may be at higher risk of residual paralysis; thus, a lower maximum initial bolus is recommended in these patients
•
Laudanosine, an active metabolite of cisatracurium besylate, has been shown to cause seizures in animals. Cisatracurium besylate – treated patients with renal or hepatic impairment may have higher metabolite concentrations (including laudanosine) than patients with normal renal and hepatic function
The level of neuromuscular blockade during long-term cisatracurium besylate administration should be monitored with a nerve stimulator to titrate cisatracurium besylate administration to the patients’ needs and limit exposure to toxic metabolites.
•
• Cisatracurium besylate is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to cisatracurium besylate have been reported
• Known hypersensitivity to cisatracurium ]
•
Administration of cisatracurium besylate results in paralysis, which may lead to respiratory arrest and death, a progression that may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labeled and communicated.
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Neuromuscular blockade in the conscious patient can lead to distress. Use cisatracurium besylate in the presence of appropriate sedation or general anesthesia. Monitor patients to ensure that the level of anesthesia is adequate.