FDA

Cisatracurium Besylate Preservative Free

Approved 3 Feb 2012InjectionInjectable

The FDA lists this product in 13 strengths and forms.

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Indications

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 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 is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action (1)

Contraindications

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 )

Warnings and precautions

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 )

Indications

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 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 is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action (1)

Warnings and precautions

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 )

Interactions

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 )

7.1Clinically 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

1.25Minimum 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

7.2Drugs 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.

Adverse reactions

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 Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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.

6.2Postmarketing 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.

Cisatracurium Besylate Preservative Free

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Cisatracurium Besylate Preservative Free

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Residual Paralysis

5.3Risk of Seizure Laudanosine,

5.4Hypersensitivity Reactions Including Anaphylaxis

5.5Risk of Death Due to Medication Errors Administration

5.6Risks Due to Inadequate Anesthesia

5.8Potentiation of Neuromuscular Blockade

5.9Resistance to Neuromuscular Blockade with Certain Drugs

5.10Malignant Hyperthermia (MH)

Interactions

7.1Clinically Significant Drug Interactions Table

1.25Minimum Alveolar Concentration

7.2Drugs Without Clinically Significant Drug Interactions With Cisatracurium Besylate

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Studies Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance