CISATRACURIUM BESYLATE — cisatracurium besylate injection
Somerset Therapeutics, LLC
- 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, USP is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
- Cisatracurium besylate injection is for intravenous use only.
- Administer cisatracurium besylate injection in carefully adjusted dosage by or under the supervision of experienced clinicians who are familiar with the drug’s actions and the possible complications.
- Use cisatracurium besylate injection only if the following are immediately available: personnel and facilities for resuscitation and life support (tracheal intubation, artificial ventilation, oxygen therapy); and an antagonist of cisatracurium besylate injection [see Overdosage (10)].
- The dosage information which follows is intended to serve as an initial guide for individual patients; base subsequent cisatracurium besylate injection dosage on the patient’s responses to the initial doses.
- Use a peripheral nerve stimulator to:
o Minimize risk of overdosage or underdosage.
o Assess the extent of recovery from neuromuscular blockade (e.g., spontaneous recovery or recovery after administration of a reversal agent, e.g., neostigmine).
o Appropriately titrate doses to potentially limit exposure to toxic metabolites.
o Facilitate more rapid reversal of the cisatracurium besylate injection-induced paralysis.
Risk of Medication Errors
Accidental administration of neuromuscular blocking agents may be fatal. Store cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions (5.5)].
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 [see Clinical Pharmacology (12.2)].
Patients with Neuromuscular 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) [see Warnings and Precautions (5.1)].
Geriatric Patients and Patients with End-Stage Renal Disease
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 [see Use in Specific Populations (8.5, 8.6) and Clinical Pharmacology (12.3)].
Tracheal Intubation in Pediatric Patients
Infants 1 to 23 Months of Age
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) [see Clinical Studies (14.2)].
Pediatric Patients 2 to 12 Years of Age
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) [see Clinical Studies (14.2)].
2.3 Recommended Maintenance Bolus Cisatracurium Besylate Injection Doses in Adult Surgical Procedures
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 [see Clinical Pharmacology (12.2)]. No adjustment to the initial cisatracurium besylate injection maintenance bolus dose should be necessary when cisatracurium besylate injection is administered shortly after initiation of volatile agents or when used in patients receiving propofol anesthesia.
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 [see Use in Specific Populations (8.8)].
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 infusion rate is 3 mcg/kg/minute [see Dosage and Administration (2.6)]. Subsequently reduce the rate to 1 to 2 mcg/kg/minute to maintain continuous neuromuscular blockade. Use peripheral nerve stimulation to assess the level of neuromuscular blockade and to appropriately titrate the cisatracurium infusion rate. If no response is elicited to peripheral nerve stimulation, discontinue the infusion until a response returns.
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) [see Clinical Pharmacology (12.2)]. Greater reductions in the cisatracurium infusion rate may be required with longer durations of administration of isoflurane or with the administration of other inhalational anesthetics.
Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
Consider reducing the infusion rate in patients undergoing CABG with induced hypothermia to half the rate required during normothermia [see Clinical Pharmacology (12.2)]. Spontaneous recovery from neuromuscular block following discontinuation of infusion of cisatracurium infusion is expected to proceed at a rate comparable to that following administration of a single bolus dose.
Continuous Infusion for Mechanical Ventilation in the Intensive Care Unit in Adults
During extended need for mechanical ventilation and skeletal muscle relaxation in the intensive care unit (ICU), cisatracurium besylate injection may be administered by continuous infusion to adults if a patient has spontaneous recovery of neuromuscular function 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.
The recommended cisatracurium infusion rate in adult patients in the ICU is 3 mcg/kg/minute (range: 0.5 to 10.2 mcg/kg/minute) [see Dosage and Administration (2.6)]. Use peripheral nerve stimulation to assess the level of neuromuscular blockade and to appropriately titrate the cisatracurium infusion rate.
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