Medicine guide

Cisatracurium Besylate

2 mg/mL · Injection

Prescription only
Nondepolarizing Neuromuscular Blocker

Active substance: Cisatracurium Besylate
Made by: Zydus Pharmaceuticals USA Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-08-16

What it is

Nondepolarizing Neuromuscular Blocker

Used for

As an adjunct to general anesthesia to facilitate tracheal intubation in

The label’s usual adult dose

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 )] .

Lactated Ringer's and 5% Dextrose Injection Store this diluted cisatracurium besylate injection solution under refrigeration for no more than 24 hours.

Full directions ↓

Do not take it if

Cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

28other products contain Cisatracurium Besylate — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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 Limitations of Use Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action.
Cisatracurium besylate injection is a nondepolarizing neuromuscular blocker indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation in
adults and in pediatric patients 1 month to 12 years of age ( 1 ) to provide skeletal muscle relaxation during surgery in
adults and in pediatric patients 2 to 12 years of age as a bolus or infusion maintenance ( 1 ) for mechanical ventilation in the ICU in
adults ( 1 ) Limitations of Use:
Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action ( 1 )

From the official label · 2024-08-16 · DailyMed

How it works

From this product’s own US prescribing label.

Cisatracurium besylate binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine, resulting in blockade of neuromuscular transmission.
This action is antagonized by acetylcholinesterase inhibitors such as neostigmine.

How the body breaks it down

Laudanosine is further metabolized to desmethyl metabolites which are conjugated with glucuronic acid and excreted in the urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-08-16

Do not take it if

Cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium.
Severe anaphylactic reactions to cisatracurium besylate have been reported [see Warnings and Precautions ( 5.4 )] .
Known hypersensitivity to cisatracurium ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Store cisatracurium besylate injection that minimizes the possibility of selecting the wrong product (2.1) Administer intravenously only by or under the supervision of experienced clinicians familiar with drug's actions and possible complications ( 2.1 ) Use only if personnel and facilities for resuscitation and life support, and a cisatracurium besylate antagonist are immediately available ( 2.1 ) 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 ( 2.1 ) 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 ( 2.2 , 2.3 , 2.4 , 2.5 ) Continuous infusion rates ( 2.6 ) Preparation instructions ( 2.7 ) Drug compatibility ( 2.8 )
2.1 Important Dosage and Administration Instructions 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 )] .
Important Administration Instructions Cisatracurium besylate is for intravenous use only.
Administer cisatracurium besylate 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 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 [see Overdosage ( 10 )] .
The dosage information which follows is intended to serve as an initial guide for individual patients; base subsequent cisatracurium besylate dosage on the patients' responses to the initial doses.
Use a peripheral nerve stimulator to:
Determine the adequacy of neuromuscular blockade (e.g., need for additional cisatracurium besylate 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-induced paralysis.
2.2 Recommended Cisatracurium Besylate Dose for Performing Tracheal Intubation Tracheal Intubation in
Adults Prior to selecting the initial cisatracurium besylate 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 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 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 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 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 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 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 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 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 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 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 0.15 mg/kg; 50 to 60 minutes after an initial dose of cisatracurium besylate 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 [see Clinical Pharmacology ( 12.2 )] .
No adjustment to the initial cisatracurium besylate maintenance bolus dose should be necessary when cisatracurium besylate is administered shortly after initiation of volatile agents or when used in patients receiving propofol anesthesia.
2.4 Dosage in Burn Patients Burn patients have been shown to develop resistance to nondepolarizing neuromuscular blocking agents; therefore, consider increasing the cisatracurium besylate dosages for intubation and maintenance [see Use in Specific Populations ( 8.8 )] .
Dosage for Continuous Infusion Continuous Infusion for Surgical Procedures in
Adults and Pediatric Patients During extended surgical procedures, cisatracurium besylate 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 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 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 besylate 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 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 besylate 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 cisatracurium besylate 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 may be administered by continuous infusion to
adults if a patient has spontaneous recovery of neuromuscular function after the initial cisatracurium besylate 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 besylate 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 besylate infusion rate.
2.6 Rate Tables for Continuous Infusion The intravenous infusion rate depends upon the cisatracurium besylate 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 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.
Table 1:
Cisatracurium Besylate Infusion Rates for Maintenance of Neuromuscular Blockade During Opioid/Nitrous Oxide/Oxygen Anesthesia with a Concentration of 0.1 mg/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 Infusion Rates for Maintenance of Neuromuscular Blockade During Opioid/Nitrous Oxide/Oxygen Anesthesia with a Concentration of 0.4 mg/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 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 5 mL and 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.
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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Residual Paralysis : Patients with neuromuscular diseases are at higher risk.
Use a lower initial bolus dose and consider using a reversal agent in these patients.
( 2.2 , 5.1 ) Risk of Seizure :
Monitor level of neuromuscular blockade during long-term administration to limit exposure to toxic metabolites ( 5.3 ) Hypersensitivity Reactions and Anaphylaxis :
Severe hypersensitivity reactions including anaphylactic reactions have been reported.
Consider cross-reactivity among neuromuscular blocking agents, both depolarizing and non-depolarizing.
( 4 , 5.4 ) Risk of Death due to Medication Errors :
Accidental administration can cause death.
( 5.5 ) Inadequate Anesthesia :
Use cisatracurium besylate in the presence of appropriate sedation or general anesthesia and monitor patients to ensure level of anesthesia is adequate ( 5.6 )
5.1 Residual Paralysis 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 [see Dosage and Administration ( 2.2 ) and Use in Specific Populations ( 8.10 )] .
To prevent complications resulting from cisatracurium besylate-associated residual paralysis, extubation is recommended only after the patient has recovered sufficiently from neuromuscular blockade.
Consider use of a reversal agent especially in cases where residual paralysis is more likely to occur [see Overdosage ( 10 )] .
5.3 Risk of Seizure 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 [see Clinical Pharmacology ( 12.3 )] .
Therefore, patients with renal or hepatic impairment receiving extended administration of cisatracurium besylate may be at higher risk of seizures.
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.
5.4 Hypersensitivity Reactions Including Anaphylaxis Severe hypersensitivity reactions, including fatal and life-threatening anaphylactic reactions, have been reported [see Contraindications ( 4 )] .
There have been reports of wheezing, laryngospasm, bronchospasm, rash and itching following cisatracurium besylate administration in pediatric patients.
Due to the potential severity of these reactions, appropriate precautions such as the immediate availability of appropriate emergency treatment should be taken.
Precautions should also be taken in those patients who have had previous anaphylactic reactions to other neuromuscular blocking agents since cross-reactivity between neuromuscular blocking agents, both depolarizing and non-depolarizing, has been reported.
5.5 Risk of Death Due to Medication Errors 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.
5.6 Risks Due to Inadequate Anesthesia 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.
5.7 Risk for Infection The 20 mL vial of cisatracurium besylate is intended only for administration as an infusion for use in a single patient in the ICU.
The 20 mL vial should not be used multiple times because there is a higher risk of infection (the 20 mL vial does not contain a preservative).
5.8 Potentiation of Neuromuscular Blockade Certain drugs may enhance the neuromuscular blocking action of cisatracurium besylate including inhalational anesthetics, antibiotics, magnesium salts, lithium, local anesthetics, procainamide and quinidine [see Drug Interactions ( 7.1 )] .
Additionally, acid-base and/or serum electrolyte abnormalities may potentiate the action of neuromuscular blocking agents.
Use peripheral nerve stimulation and monitor the clinical signs of neuromuscular blockade to determine the adequacy of the level of neuromuscular blockage and the need to adjust the cisatracurium besylate dosage.
5.9 Resistance to Neuromuscular Blockade with Certain Drugs Shorter durations of neuromuscular block may occur and cisatracurium besylate infusion rate requirements may be higher in patients chronically administered phenytoin or carbamazepine [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .
Use peripheral nerve stimulation and monitor the clinical signs of neuromuscular blockade to determine the adequacy of neuromuscular blockage and the need to adjust the cisatracurium besylate dosage.
5.10 Malignant Hyperthermia (MH) Cisatracurium besylate has not been studied in MH-susceptible patients.
Because MH can develop in the absence of established triggering agents, the clinician should be prepared to recognize and treat MH in any patient undergoing general anesthesia.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Animal studies conducted in rats administered cisatracurium besylate during organogenesis (Gestational Day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting IV bolus dose of 0.2 mg/kg.
(see Data).
The estimated background risk for major birth defects and miscarriage in the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Labor or Delivery The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of preeclampsia or eclampsia of pregnancy.
Data Animal Data Two embryofetal developmental reproductive toxicity studies were conducted in rats.
In a non-ventilated rat study, pregnant animals were treated with cisatracurium besylate subcutaneously twice per day from Gestational Day 6 to 15 using subparalyzing doses (2 and 4 mg/kg daily; equivalent to 6- and 12-times, respectively, the AUC exposure in humans following a bolus dose of 0.2 mg/kg IV).
In the ventilated rat study, pregnant animals were treated with cisatracurium besylate intravenously once a day between Gestational Day 6 to 15 using paralyzing doses (0.5 and 1 mg/kg; equivalent to 0.4- and 0.8-times, respectively, the exposure in humans following a bolus dose of 0.2 mg/kg IV based on mg/m 2 comparison).
Neither of these studies revealed maternal or fetal toxicity or malformation.
IN SPECIFIC POPULATIONS Patients with Hemiparesis or Paraparesis :
Perform neuromuscular monitoring on non-paretic limb ( 8.9 )
8.1 Pregnancy Risk Summary There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Animal studies conducted in rats administered cisatracurium besylate during organogenesis (Gestational Day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting IV bolus dose of 0.2 mg/kg.
(see Data).
The estimated background risk for major birth defects and miscarriage in the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Labor or Delivery The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of preeclampsia or eclampsia of pregnancy.
Data Animal Data Two embryofetal developmental reproductive toxicity studies were conducted in rats.
In a non-ventilated rat study, pregnant animals were treated with cisatracurium besylate subcutaneously twice per day from Gestational Day 6 to 15 using subparalyzing doses (2 and 4 mg/kg daily; equivalent to 6- and 12-times, respectively, the AUC exposure in humans following a bolus dose of 0.2 mg/kg IV).
In the ventilated rat study, pregnant animals were treated with cisatracurium besylate intravenously once a day between Gestational Day 6 to 15 using paralyzing doses (0.5 and 1 mg/kg; equivalent to 0.4- and 0.8-times, respectively, the exposure in humans following a bolus dose of 0.2 mg/kg IV based on mg/m 2 comparison).
Neither of these studies revealed maternal or fetal toxicity or malformation.
8.2 Lactation There are no data on the presence of cisatracurium besylate in human milk, the effects on the breastfed child, or the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cisatracurium besylate and any potential adverse effects on the breastfed child from cisatracurium besylate or from the underlying maternal condition.
8.4 Pediatric Use The safety and effectiveness of cisatracurium besylate as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery in pediatric patients 1 month through 12 years of age were established from three studies in pediatric patients [see Dosing and Administration ( 2.2 , 2.5 ) and Clinical Studies ( 14.2 )] .
The three open-label studies are summarized below.
The safety and effectiveness of cisatracurium besylate have not been established in pediatric patients less than 1 month of age.
Tracheal Intubation A study of 0.15 mg/kg cisatracurium besylate evaluated 230 pediatric patients (ages 1 month to 12 years).
Excellent or good intubating conditions were produced 120 seconds following 0.15 mg/kg of cisatracurium besylate in 88 of 90 of patients induced with halothane and in 85 of 90 of patients induced with thiopentone and fentanyl.
The study also evaluated 50 pediatric patients during opioid anesthesia, with maximum neuromuscular blockade achieved in an average of about 3 minutes and a clinically effective block for 36 minutes in patients ages 2 to 12 years, and maximum neuromuscular block in about 2 minutes and a clinically effective block for about 43 minutes in infants 1 to 23 months [see Clinical Studies ( 14.2 )] .
In a study of 0.1 mg/kg cisatracurium besylate administered in 16 pediatric patients (ages 2 to 12 years) during opioid/nitrous oxide/oxygen anesthesia, maximum neuromuscular blockade was achieved in an average of 2.8 minutes with a clinically effective block for 28 minutes [see Clinical Studies ( 14.2 )] .
Skeletal Muscle Relaxation During Surgery In a study of cisatracurium besylate administered during halothane/nitrous oxide/oxygen anesthesia, 18 pediatric patients (ages 2 to 12 years) were scheduled for surgical procedures that required neuromuscular block for 60 minutes or longer.
The average duration of continuous infusion was 62.8 minutes (range: 17 to 145 minutes).
The overall mean infusion rate for 9 patients whose infusion was 45 minutes or longer was 1.7 mcg/kg/minute (range:
1.19 to 2.14 mcg/kg/minute).
8.5 Geriatric Use Of the total number of subjects (135) in clinical studies of cisatracurium besylate, 57, 63, and 15 subjects were 65-70 years old, 70-80 years old, and greater than 80 years old, respectively.
The geriatric population included a subset of patients with significant cardiovascular disease [see Clinical Pharmacology ( 12.3 )] .
Because the time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients compared to younger patients, consider extending the interval between administering cisatracurium besylate and attempting intubation by at least 1 minute to achieve adequate intubation conditions [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.2 )] .
The time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients, a difference that should be taken into account when selecting a neuromuscular blocking agent (e.g., the need to rapidly secure the airway) and when initiating laryngoscopy [see Clinical Pharmacology ( 12.3 )] .
Minor differences in the pharmacokinetics of cisatracurium between elderly and young adult patients were not associated with clinically significant differences in the recovery profile of cisatracurium besylate following a single 0.1 mg/kg dose.
Besides the differences noted above, no overall differences in safety or effectiveness were observed between geriatric and younger subjects, and other reported clinical experience has not identified differences in responses between geriatric and younger subjects, but greater sensitivity of some older individuals to cisatracurium besylate cannot be ruled out.
8.6 Patients with Renal Impairment The time to 90% neuromuscular blockade was 1 minute slower in patients with end-stage renal disease than in patients with normal renal function.
Therefore, consider extending the interval between administering cisatracurium besylate and attempting intubation by at least 1 minute to achieve adequate intubation conditions [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.2 )] .
There was no clinically significant alteration in the recovery profile of cisatracurium besylate in patients with end-stage renal disease following a 0.1 mg/kg dose of cisatracurium besylate.
The recovery profile of cisatracurium besylate is unchanged in patients with renal impairment, which is consistent with predominantly organ-independent elimination [see Clinical Pharmacology ( 12.3 )] .
8.7 Patients with Hepatic Impairment The pharmacokinetic study analysis in patients with end-stage liver disease undergoing liver transplantation and healthy subjects undergoing elective surgery indicated slightly larger volumes of distribution in liver transplant patients with slightly higher plasma clearances of cisatracurium.
The times to maximum neuromuscular blockade were approximately one minute faster in liver transplant patients than in healthy adult patients receiving 0.1 mg/kg cisatracurium besylate.
These minor differences in pharmacokinetics were not associated with clinically significant differences in the recovery profile of cisatracurium besylate [see Clinical Pharmacology ( 12.3 )] .
8.8 Burn Patients Patients with burns have been shown to develop resistance to nondepolarizing neuromuscular blocking agents.
The extent of altered response depends upon the size of the burn and the time elapsed since the burn injury.
Cisatracurium besylate has not been studied in patients with burns.
However, based on its structural similarity to another neuromuscular blocking agent, consider the possibility of increased dosage requirements and shortened duration of action if cisatracurium besylate is administered to burn patients.
8.9 Patients with Hemiparesis or Paraparesis 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.
8.10 Patients with Neuromuscular Disease Profound and prolonged neuromuscular blockade may occur in patients with neuromuscular diseases (e.g., myasthenia gravis and myasthenic syndrome) and carcinomatosis.
Therefore, a lower maximum initial bolus is recommended in these patients [see Dosage and Administration ( 2.2 )] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Succinylcholine :
May decrease time to onset of maximum neuromuscular blockade ( 7.1 ) Inhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine :
May potentiate or prolong neuromuscular blockade action of cisatracurium besylate.
Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade.
( 5.8 , 7.1 ) Phenytoin and Carbamazepine :
May shorten duration of neuromuscular blockade.
Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade.
( 5.9 , 7.1 )
7.1 Clinically Significant Drug Interactions Table 4 displays clinically significant drug interactions with cisatracurium besylate.
Table 4:
Clinically Significant Drug Interactions with Cisatracurium Besylate Drug or Drug Class Clinical Implications * Succinylcholine The use of succinylcholine prior to cisatracurium besylate administration may decrease the time to onset of maximum neuromuscular blockade but has no effect on the duration of neuromuscular blockade.
Inhalational Anesthetics Administration of inhalational anesthetics with nitrous oxide/oxygen for greater than 30 minutes to achieve
1.25 Minimum Alveolar Concentration (MAC) may prolong the duration of action of initial and maintenance doses of cisatracurium besylate.
This may potentiate the neuromuscular blockade.
Antibiotics † Local anesthetics Magnesium salts Procainamide Lithium Quinidine May prolong the neuromuscular blockade action of cisatracurium besylate.
Phenytoin, Carbamazepine May increase resistance to the neuromuscular blockade action of cisatracurium besylate resulting in shorter durations of neuromuscular blockade and infusion rate requirements may be higher. * The use of peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of cisatracurium besylate, and to determine whether adjustments need to be made to the dose with subsequent administration. † Examples:
aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, sodium colistimethate
7.2 Drugs Without Clinically Significant Drug Interactions With Cisatracurium Besylate In clinical studies, propofol had no effect on the duration of action or dosing requirements for cisatracurium besylate.
Cisatracurium besylate is not compatible with propofol for Y-site administration.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Overdosage with neuromuscular blocking agents may result in neuromuscular blockade 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 a cholinesterase inhibitor (e.g., neostigmine, edrophonium) in conjunction with an appropriate cholinergic inhibitor.
Cholinesterase inhibitors should not be administered when complete neuromuscular blockade is evident or suspected because the reversal of paralysis may not be sufficient to maintain a patent airway and support an appropriate level of spontaneous ventilation.
Neostigmine :
Administration of 0.04 to 0.07 mg/kg of neostigmine at approximately 10% recovery from neuromuscular blockade (range:
0 to 15%) produced 95% recovery of the muscle twitch response and a T 4 :T 1 ratio ≥ 70% in an average of 9 to 10 minutes.
The times from 25% recovery of the muscle twitch response to a T 4 :T 1 ratio ≥ 70% following these doses of neostigmine averaged 7 minutes.
The mean 25% to 75% recovery index following reversal was 3 to 4 minutes.
Edrophonium :
Administration of 1 mg/kg of edrophonium at approximately 25% recovery from neuromuscular blockade (range:
16% to 30%) produced 95% recovery and a T 4 :T 1 ratio ≥ 70% in an average of 3 to 5 minutes.
For providers treating patients treated with cholinesterase inhibitors:
Use a peripheral nerve stimulator to evaluate recovery and antagonism of neuromuscular blockade.
Evaluate for evidence of adequate clinical recovery (e.g., 5-second head lift and grip strength).
Support ventilation until adequate spontaneous ventilation has resumed.
The onset of antagonism may be delayed in the presence of debilitation, cachexia, carcinomatosis, and the concomitant use of certain broad spectrum antibiotics, or anesthetic agents and other drugs which enhance neuromuscular block or separately cause respiratory depression [see Drug Interactions ( 7.1 )] .
Under such circumstances the management is the same as that of prolonged neuromuscular block.

Quoted from the official label, section “Overdosage”.

Use in children

The safety and effectiveness of cisatracurium besylate as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery in pediatric patients 1 month through 12 years of age were established from three studies in pediatric patients [see Dosing and Administration ( 2.2 , 2.5 ) and Clinical Studies ( 14.2 )] .
The three open-label studies are summarized below.
The safety and effectiveness of cisatracurium besylate have not been established in pediatric patients less than 1 month of age.
Tracheal Intubation A study of 0.15 mg/kg cisatracurium besylate evaluated 230 pediatric patients (ages 1 month to 12 years).
Excellent or good intubating conditions were produced 120 seconds following 0.15 mg/kg of cisatracurium besylate in 88 of 90 of patients induced with halothane and in 85 of 90 of patients induced with thiopentone and fentanyl.
The study also evaluated 50 pediatric patients during opioid anesthesia, with maximum neuromuscular blockade achieved in an average of about 3 minutes and a clinically effective block for 36 minutes in patients ages 2 to 12 years, and maximum neuromuscular block in about 2 minutes and a clinically effective block for about 43 minutes in infants 1 to 23 months [see Clinical Studies ( 14.2 )] .
In a study of 0.1 mg/kg cisatracurium besylate administered in 16 pediatric patients (ages 2 to 12 years) during opioid/nitrous oxide/oxygen anesthesia, maximum neuromuscular blockade was achieved in an average of 2.8 minutes with a clinically effective block for 28 minutes [see Clinical Studies ( 14.2 )] .
Skeletal Muscle Relaxation During Surgery In a study of cisatracurium besylate administered during halothane/nitrous oxide/oxygen anesthesia, 18 pediatric patients (ages 2 to 12 years) were scheduled for surgical procedures that required neuromuscular block for 60 minutes or longer.
The average duration of continuous infusion was 62.8 minutes (range: 17 to 145 minutes).
The overall mean infusion rate for 9 patients whose infusion was 45 minutes or longer was 1.7 mcg/kg/minute (range:
1.19 to 2.14 mcg/kg/minute).

Quoted from the official label, section “Pediatric Use”.

Use in older people

Of the total number of subjects (135) in clinical studies of cisatracurium besylate, 57, 63, and 15 subjects were 65-70 years old, 70-80 years old, and greater than 80 years old, respectively.
The geriatric population included a subset of patients with significant cardiovascular disease [see Clinical Pharmacology ( 12.3 )] .
Because the time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients compared to younger patients, consider extending the interval between administering cisatracurium besylate and attempting intubation by at least 1 minute to achieve adequate intubation conditions [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.2 )] .
The time to maximum neuromuscular blockade is approximately 1 minute slower in geriatric patients, a difference that should be taken into account when selecting a neuromuscular blocking agent (e.g., the need to rapidly secure the airway) and when initiating laryngoscopy [see Clinical Pharmacology ( 12.3 )] .
Minor differences in the pharmacokinetics of cisatracurium between elderly and young adult patients were not associated with clinically significant differences in the recovery profile of cisatracurium besylate following a single 0.1 mg/kg dose.
Besides the differences noted above, no overall differences in safety or effectiveness were observed between geriatric and younger subjects, and other reported clinical experience has not identified differences in responses between geriatric and younger subjects, but greater sensitivity of some older individuals to cisatracurium besylate cannot be ruled out.

Quoted from the official label, section “Geriatric Use”.

Side effects

The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Clinical Trials of Cisatracurium Besylate in Surgical Patients The data presented below are based on studies involving 945 surgical patients who received cisatracurium besylate in conjunction with other drugs in US and European clinical studies in a variety of procedures [see Clinical Studies ( 14.1 )] .
Table 3 displays adverse reactions that occurred at a rate of less than 1%.
Table 3:
Adverse Reactions in Clinical Trials of Cisatracurium Besylate in Surgical Patients Adverse Reaction Incidence Bradycardia 0.4% Hypotension 0.2% Flushing 0.2% Bronchospasm 0.2% Rash 0.1% Adverse Reactions in Clinical Trials of Cisatracurium Besylate in Intensive Care Unit Patients The adverse reactions presented below were from studies involving 68 adult ICU patients who received cisatracurium besylate in conjunction with other drugs in US and European clinical studies [see Clinical Studies ( 14.3 )] .
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 (range:
167 and 270 minutes) among 28 patients administered cisatracurium besylate and 13 reports of prolonged recovery (range:
90 minutes to 33 hours) among 30 patients administered vecuronium.
6.2 Postmarketing Experience 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:
anaphylaxis, histamine release, prolonged neuromuscular block, muscle weakness, myopathy.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Hypersensitivity Reactions Including Anaphylaxis Advise the caregiver and/or family that severe hypersensitivity reactions have occurred with cisatracurium besylate [see Warnings and Precautions ( 5.4 )] .
Manufactured by: Zydus Lifesciences Ltd.
Vadodara, India.
Distributed by: Zydus Pharmaceuticals (USA) Inc.
Pennington, NJ 08534 Revised: 12/22

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

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/mL) in single-dose vials (equivalent to 2.68 mg/mL cisatracurium besylate) 200 mg of cisatracurium per 20 mL (10 mg/mL) in single-dose vials (equivalent to 13.38 mg/mL cisatracurium besylate); intended only for administration as an infusion in a single patient in the ICU.
Injection:
10 mg/5 mL (2 mg/mL) in single-dose vials ( 3 ) 200 mg/20 mL (10 mg/mL) in single-dose vials ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Cisatracurium besylate injection USP is a clear solution supplied as follows:
Strength (mg of cisatracurium) Containers NDC# Pack Style 10 mg/5 mL (2 mg/mL) Single-dose vials 70710-1532-6 10 vials per carton 200 mg/20 mL (10 mg/mL) Single-dose vials 70710-1534-6 10 vials per carton Discard unused portion of the 5 mL and 20 mL single-dose vials.
Storage Refrigerate cisatracurium besylate injection USP at 2°C to 8°C (36°F to 46°F) in the carton to preserve potency.
Protect from light.
DO NOT FREEZE.
Upon removal of the unused vial from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium besylate injection USP within 21 days, even if re-refrigerated.

Quoted from the official label, section “How Supplied”.

What is in it

Cisatracurium besylate injection USP is a nondepolarizing skeletal neuromuscular blocker for intravenous administration.
Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action.
Cisatracurium besylate USP is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture.
Cisatracurium besylate USP is [1 R -[1α,2α(1' R *,2' R *)]]-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 C 53 H 72 N 2 O 12 and the molecular weight is 929.2.
The molecular formula of cisatracurium as the besylate salt is C 65 H 82 N 2 O 18 S 2 and the molecular weight is 1243.49.
The structural formula of cisatracurium besylate USP is:
The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C.
Each mL in the single-dose vials contains either 2 mg or 10 mg of cisatracurium (equivalent to 2.68 mg and 13.38 mg of cisatracurium besylate; respectively), and benzenesulfonic acid as pH adjuster in water for injection.
The pH of cisatracurium besylate injection, USP is between 3.25 and 3.65.
Image

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made by	Zydus Pharmaceuticals USA Inc.
Active substance	Cisatracurium Besylate
Strength	2 mg/mL
Form	Injection
Route	Intravenous
Packs	10 VIAL in 1 CARTON / 5 mL in 1 VIAL
NDC	70710-1532

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

27 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Injection21 products
- 2 mg/mL9
  2 mg/mL · 9 companies
  +1 more
- 10 mg/mL9
  10 mg/mL · 9 companies
  +1 more
- 10 mg/5mL
- 20 mg/10mL
- 200 mg/20mL
Injection, Solution6 products
- 2 mg/mL
- 10 mg/mL2
  10 mg/mL · 2 companies
  - Avenacy, LLC
  - Hospira, Inc.
- 10 mg/5mL
- 20 mg/10mL
- 200 mg/20mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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