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Cisatracurium
Overview
What is Cisatracurium?
Cisatracurium Besylate Injection, USP is a non-depolarizing skeletal muscle relaxant for intravenous administration. Compared to other neuromuscular blocking agents, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1 -[1α,2α(1'*,2'*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is CHNO and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is CHNOSand the molecular weight is 1243.50.
The structural formula of cisatracurium besylate is:
The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C.
Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 mL, and 20 mL vials. The pH is adjusted to 3.25 to 3.65 with benzenesulfonic acid. The 5 mL and 10 mL vials each contain cisatracurium besylate, equivalent to 2 mg/mL cisatracurium. The 20 mL vial, contains cisatracurium besylate, equivalent to 10 mg/mL cisatracurium. The 10 mL vial, intended for multiple dose use, contains 0.9% benzyl alcohol as a preservative. The 5 mL and 20 mL vials are single dose vials and do not contain benzyl alcohol.
Cisatracurium besylate slowly loses potency with time at a rate of approximately 5% per year under refrigeration (5°C). Cisatracurium should be refrigerated at 2° to 8°C (36° to 46°F) in the carton to preserve potency. The rate of loss in potency increases to approximately 5% per at 25°C (77°F). Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium within 21 days, even if rerefrigerated.
What does Cisatracurium look like?
What are the available doses of Cisatracurium?
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What should I talk to my health care provider before I take Cisatracurium?
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How should I use Cisatracurium?
Cisatracurium Besylate Injection is an intermediate-onset/intermediate-duration neuromuscular blocking agent indicated for inpatients and outpatients as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU.
NOTE: CONTAINS BENZYL ALCOHOL (see and
).
CISATRACURIUM BESYLATE INJECTION SHOULD ONLY BE ADMINISTERED INTRAVENOUSLY.
The dosage information provided below is intended as a guide only. Doses of Cisatracurium should be individualized (see
). The use of a peripheral nerve stimulator will permit the most advantageous use of cisatracurium, minimize the possibility of overdosage or underdosage, and assist in the evaluation of recovery.
What interacts with Cisatracurium?
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What are the warnings of Cisatracurium?
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What are the precautions of Cisatracurium?
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What are the side effects of Cisatracurium?
Observed in Clinical Trials of Surgical Patients
Adverse experiences were uncommon among the 945 surgical patients who received cisatracurium in conjunction with other drugs in US and European clinical studies in the course of a wide variety of procedures in patients receiving opioid, propofol, or inhalation anesthesia. The following adverse experiences were judged by investigators during the clinical trials to have a possible causal relationship to administration of cisatracurium:
Incidence Greater than 1%
None.
Incidence Less than 1%
Cardiovascular
bradycardia (0.4%)
hypotension (0.2%)
flushing (0.2%)
Respiratory
bronchospasm (0.2%)
Dermatological
rash (0.1%)
Observed in Clinical Trials of Intensive Care Unit Patients
Adverse experiences were uncommon among the 68 ICU patients who received cisatracurium in conjunction with other drugs in US and European clinical studies. One patient experienced bronchospasm. In one of the two ICU studies, a randomized and double-blind study of ICU patients using TOF neuromuscular monitoring, there were two reports of prolonged recovery (167 and 270 minutes) among 28 patients administered cisatracurium and 13 reports of prolonged recovery (range: 90 minutes to 33 hours) among 30 patients administered vecuronium.
Observed During Clinical Practice
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of cisatracurium besylate in conjunction with one or more anesthetic agents in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to cisatracurium besylate.
General
Histamine release, hypersensitivity reactions including anaphylactic or anaphylactoid reactions which in some cases have been life threatening and fatal. Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see and ). There are rare reports of wheezing, laryngospasm, bronchospasm, rash and itching following administration of cisatracurium in children. These reported adverse events were not serious and their etiology could not be established with certainty.
Musculoskeletal
Prolonged neuromuscular block, inadequate neuromuscular block, muscle weakness, and myopathy.
What should I look out for while using Cisatracurium?
Cisatracurium is contraindicated in patients with known hypersensitivity to the product and its components. The 10 mL multiple dose vials of cisatracurium is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see and ).
What might happen if I take too much Cisatracurium?
Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway and controlled ventilation until recovery of normal neuromuscular function is assured. Once recovery from neuromuscular block begins, further recovery may be facilitated by administration of an anticholinesterase agent (e.g., neostigmine, edrophonium) in conjunction with an appropriate anticholinergic agent (see below).
How should I store and handle Cisatracurium?
Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Storage ConditionsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light.Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.The container closure is not made with natural rubber latex.Cisatracurium Besylate Injection, USP is supplied as:NOTE: Cisatracurium Besylate Injection, USP is supplied as:Intended only for use in the ICU.Cisatracurium Besylate Injection, USP is supplied as:NOTE: Cisatracurium Besylate Injection, USP is supplied as:Intended only for use in the ICU.Cisatracurium Besylate Injection, USP is supplied as:NOTE: Cisatracurium Besylate Injection, USP is supplied as:Intended only for use in the ICU.Cisatracurium Besylate Injection, USP is supplied as:NOTE: Cisatracurium Besylate Injection, USP is supplied as:Intended only for use in the ICU.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The neuromuscular blocking potency of cisatracurium is approximately threefold that of atracurium besylate. The time to maximum block is up to 2 minutes longer for equipotent doses of cisatracurium compared to atracurium besylate. The clinically effective duration of action and rate of spontaneous recovery from equipotent doses of cisatracurium and atracurium besylate are similar.
The average ED (dose required to produce 95% suppression of the adductor pollicis muscle twitch response to ulnar nerve stimulation) of cisatracurium is 0.05 mg/kg (range: 0.048 to 0.053) in adults receiving opioid/nitrous oxide/oxygen anesthesia. For comparison, the average ED for atracurium when also expressed as the parent bis-cation is 0.17 mg/kg under similar anesthetic conditions.
The pharmacodynamics of 2 x ED to 8 x ED doses of cisatracurium administered over 5 to 10 seconds during opioid/nitrous oxide/oxygen anesthesia are summarized in Table 1. When the dose is doubled, the clinically effective duration of block increases by approximately 25 minutes. Once recovery begins, the rate of recovery is independent of dose.
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, and decrease the average infusion rate requirement of cisatracurium. 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 and therefore, no adjustment to the initial dose should be necessary when cisatracurium is administered shortly after initiation of volatile agents. In long surgical procedures during enflurane or isoflurane anesthesia, less frequent maintenance dosing, lower maintenance doses, or reduced infusion rates of cisatracurium may be necessary. The average infusion rate requirement may be decreased by as much as 30% to 40%.
The onset, duration of action, and recovery profiles of cisatracurium during propofol/oxygen or propofol/nitrous oxide/oxygen anesthesia are similar to those during opioid/nitrous oxide/oxygen anesthesia.
*
†
‡
§
||
Halothane anesthesia.
**
When administered during the induction of adequate anesthesia using propofol, nitrous oxide/oxygen, and co-induction agents (e.g., fentanyl and midazolam), GOOD or EXCELLENT conditions for tracheal intubation occurred in 96/102 (94%) patients in 1.5 to 2 minutes following 0.15 mg/kg cisatracurium and in 97/110 (88%) patients in 1.5 minutes following 0.2 mg/kg cisatracurium.
In one intubation study during thiopental anesthesia in which fentanyl and midazolam were administered two minutes prior to induction, intubation conditions were assessed at 120 seconds. Table 2 displays these results in this study of 51 patients.
Table 2. Study of Tracheal Intubation Comparing Two Doses of Cisatracurium (Thiopental Anesthesia)
While GOOD or EXCELLENT intubation conditions were achieved in the majority of patients in this setting, EXCELLENT intubation conditions were more frequently achieved with the 0.2 mg/kg dose (60%) than the 0.15 mg/kg dose (31%) when intubation was attempted 2 minutes following cisatracurium.
A second study evaluated intubation conditions after 3 and 4 x ED (0.15 mg/kg and 0.2 mg/kg) following induction with fentanyl and midazolam and either thiopental or propofol anesthesia. This study compared intubation conditions produced by these doses of cisatracurium after 1.5 minutes. Table 3 displays these results.
Table 3. Study of Tracheal Intubation Comparing Three Doses of Cisatracurium (Thiopental or Propofol Anesthesia)
EXCELLENT intubation conditions were more frequently observed with the 0.2 mg/kg dose when intubation was attempted 1.5 minutes following cisatracurium.
A third study in pediatric patients (ages 1 month to 12 years) evaluated intubation conditions at 120 seconds after 0.15 mg/kg cisatracurium following induction with either halothane (with halothane/nitrous oxide/oxygen maintenance) or thiopentone and fentanyl (with thiopentone/fentanyl nitrous oxide/oxygen maintenance). The results are summarized in Table 4.
Table 4. Study of Tracheal Intubation for Pediatrics Stratified by Age Group (0.15 mg/kg Cisatracurium with Halothane or Thiopentone/Fentanyl Anesthesia)
** Easy passage of the tube without coughing. Vocal cords relaxed and abducted.
Good:
Poor:
Response of patient requires adjustment of ventilation pressure and/or rate.
EXCELLENT or GOOD intubating conditions were produced 120 seconds following 0.15 mg/kg cisatracurium in 88/90 (98%) of patients induced with halothane and in 85/90 (94%) of patients induced with thiopentone and fentanyl. There were no patients for whom intubation was not possible, but there were 7/120 patients ages 1 to 12 years for whom intubating conditions were described as poor.
Repeated administration of maintenance doses or a continuous infusion of cisatracurium for up to 3 hours is not associated with development of tachyphylaxis or cumulative neuromuscular blocking effects. The time needed to recover from successive maintenance doses does not change with the number of doses administered as long as partial recovery is allowed to occur between doses. Maintenance doses can therefore be administered at relatively regular intervals with predictable results. The rate of spontaneous recovery of neuromuscular function after infusion is independent of the duration of infusion and comparable to the rate of recovery following initial doses (Table 1).
Long-term infusion (up to 6 days) of cisatracurium during mechanical ventilation in the ICU has been evaluated in two studies. In a randomized, double-blind study using presence of a single twitch during train-of-four (TOF) monitoring to regulate dosage, patients treated with cisatracurium (n = 19) recovered neuromuscular function (T:T ratio ≥ 70%) following termination of infusion in approximately 55 minutes (range: 20 to 270) whereas those treated with vecuronium (n = 12) recovered in 178 minutes (range: 40 minutes to 33 hours). In another study comparing cisatracurium and atracurium, patients recovered neuromuscular function in approximately 50 minutes for both cisatracurium (range: 20 to 175; n = 34) and atracurium (range: 35 to 85; n = 15).
The neuromuscular block produced by cisatracurium is readily antagonized by anticholinesterase agents once recovery has started. As with other non-depolarizing neuromuscular blocking agents, the more profound the neuromuscular block at the time of reversal, the longer the time required for recovery of neuromuscular function.
In children (2 to 12 years) cisatracurium has a lower ED than in adults (0.04 mg/kg, halothane/nitrous oxide/oxygen anesthesia). At 0.1 mg/kg during opioid anesthesia, cisatracurium had a faster onset and shorter duration of action in children than in adults (Table 1). Recovery following reversal is faster in children than in adults.
At 0.15 mg/kg during opioid anesthesia, cisatracurium had a faster onset and longer clinically effective duration of action in infants aged 1 to 23 months compared to children aged 2 to 12 years (Table 1).
Studies were conducted during both opioid-based and halothane-based anesthesia in children aged 1 to 11 months, 1 to 4 years, and 5 to 12 years. Cisatracurium had a faster onset and longer duration of action in infants 1 to 11 months compared to children 1 to 4 years, who in turn have a faster onset and longer duration of action for cisatracurium compared to children 5 to 12 years.
The mean time to onset of maximum T suppression was generally faster for pediatric patients induced with halothane compared to thiopentone/fentanyl and the clinically effective duration (time to 25% recovery) was longer (by up to 15%) for pediatric patients under halothane anesthesia.
Non-Clinical Toxicology
Cisatracurium is contraindicated in patients with known hypersensitivity to the product and its components. The 10 mL multiple dose vials of cisatracurium is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see and ).Caution should be exercised when propranolol is administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Coadministration of such drugs with propranolol may lead to clinically relevant drug interactions and changes on its efficacy and/or toxicity (see in ).
Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.
Quinidine increases the concentration of propranolol and produces greater degrees of clinical beta-blockade and may cause postural hypotension.
Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
The clearance of lidocaine is reduced with administration of propranolol. Lidocaine toxicity has been reported following coadministration with propranolol.
Caution should be exercised when administering propranolol with drugs that slow A-V nodal conduction, e.g. digitalis, lidocaine and calcium channel blockers.
Digitalis Glycosides
Calcium Channel Blockers
There have been reports of significant bradycardia, heart failure, and cardiovascular collapse with concurrent use of verapamil and beta-blockers.
Coadministration of propranolol and diltiazem in patients with cardiac disease has been associated with bradycardia, hypotension, high-degree heart block, and heart failure.
ACE Inhibitors
The antihypertensive effects of clonidine may be antagonized by beta-blockers. Propranolol should be administered cautiously to patients withdrawing from clonidine.
Alpha Blockers
Postural hypotension has been reported in patients taking both beta-blockers and terazosin or doxazosin.
Reserpine
Isoproterenol and Dobutamine
Administration of indomethacin with propranolol may reduce the efficacy of propranolol in reducing blood pressure and heart rate.
Antidepressants
Anesthetic Agents
Warfarin
Neuroleptic Drugs
Thyroxine
Alcohol
Because of its intermediate onset of action, cisatracurium is not recommended for rapid sequence endotracheal intubation.
Recommended doses of cisatracurium have no clinically significant effects on heart rate; therefore, cisatracurium will not counteract the bradycardia produced by many anesthetic agents or by vagal stimulation.
Neuromuscular blocking agents may have a profound effect in patients with neuromuscular diseases (e.g., myasthenia gravis and the myasthenic syndrome). In these and other conditions in which prolonged neuromuscular block is a possibility (e.g., carcinomatosis), the use of a peripheral nerve stimulator and a dose of not more than 0.02 mg/kg cisatracurium is recommended to assess the level of neuromuscular block and to monitor dosage requirements.
Patients with burns have been shown to develop resistance to non-depolarizing neuromuscular blocking agents, including atracurium. The extent of altered response depends upon the size of the burn and the time elapsed since the burn injury. Cisatracurium has not been studied in patients with burns; however, based on its structural similarity to atracurium, the possibility of increased dosing requirements and shortened duration of action must be considered if cisatracurium is administered to burn patients.
Patients with hemiparesis or paraparesis also may demonstrate resistance to non-depolarizing muscle relaxants in the affected limbs. To avoid inaccurate dosing, neuromuscular monitoring should be performed on a non-paretic limb.
Acid-base and/or serum electrolyte abnormalities may potentiate or antagonize the action of neuromuscular blocking agents. No data are available to support the use of cisatracurium by intramuscular injection.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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