Cisatracurium

Cisatracurium
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Black Box Warning

Black Box warning See full prescribing information for complete Boxed Warning. NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL

Overview

Cisatracurium is a skeletal muscle relaxant and neuromuscular blocking drugs that is FDA approved for the {{{indicationType}}} of induction of neuromuscular blockade, adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include cardiovascular: bradyarrhythmia (0.4% ), hypotension (0.2% ), , respiratory: bronchospasm (0.2%).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

dosage should be individualized and a peripheral nerve stimulator should be used to measure neuromuscular function during administration [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: initial, 0.15 to 0.2 mg/kg IV bolus as components of a propofol/nitrous oxide/oxygen induction-intubation technique [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: maintenance, 0.03 mg/kg IV [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: maintenance, initial continuous IV infusion rate of 3 mcg/kg/min may be required to rapidly counteract spontaneous recovery from initial bolus dose; thereafter, 1 to 2 mcg/kg/min continuous IV infusion [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: maintenance in ICU, 3 mcg/kg/min (infusion range of 0.5 to 10.2 mcg/kg/min) [1]

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cisatracurium in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cisatracurium in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

osage should be individualized and a peripheral nerve stimulator should be used to measure neuromuscular function during administration [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: (aged 1 to 23 months) initial, 0.15 mg/kg IV over 5 to 10 seconds during either halothane or opioid anesthesia [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: (aged 2 to 12 years) initial, 0.1 to 0.15 mg/kg IV over 5 to 10 seconds during either halothane or opioid anesthesia [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: (aged 2 to 12 years) maintenance, initial IV infusion of 3 mcg/kg/min; then decrease to 1 to 2 mcg/kg/min IV infusion [1]

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cisatracurium in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cisatracurium in pediatric patients.

Contraindications

osage should be individualized and a peripheral nerve stimulator should be used to measure neuromuscular function during administration [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: (aged 1 to 23 months) initial, 0.15 mg/kg IV over 5 to 10 seconds during either halothane or opioid anesthesia [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: (aged 2 to 12 years) initial, 0.1 to 0.15 mg/kg IV over 5 to 10 seconds during either halothane or opioid anesthesia [1] Induction of neuromuscular blockade, Adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation: (aged 2 to 12 years) maintenance, initial IV infusion of 3 mcg/kg/min; then decrease to 1 to 2 mcg/kg/min IV infusion [1]

Warnings

Black Box warning See full prescribing information for complete Boxed Warning. NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL

Anaphylaxis

Severe anaphylactic reactions to neuromuscular blocking agents, including NIMBEX, have been reported. These reactions have in some cases been life-threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those individuals 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 in this class of drugs.

Administration

NIMBEX SHOULD BE ADMINISTERED IN CAREFULLY ADJUSTED DOSAGE BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS WHO ARE FAMILIAR WITH THE DRUG'S ACTIONS AND THE POSSIBLE COMPLICATIONS OF ITS USE. THE DRUG SHOULD NOT BE ADMINISTERED UNLESS PERSONNEL AND FACILITIES FOR RESUSCITATION AND LIFE SUPPORT (TRACHEAL INTUBATION, ARTIFICIAL VENTILATION, OXYGEN THERAPY), AND AN ANTAGONIST OF NIMBEX ARE IMMEDIATELY AVAILABLE. IT IS RECOMMENDED THAT A PERIPHERAL NERVE STIMULATOR BE USED TO MEASURE NEUROMUSCULAR FUNCTION DURING THE ADMINISTRATION OF NIMBEX IN ORDER TO MONITOR DRUG EFFECT, DETERMINE THE NEED FOR ADDITIONAL DOSES, AND CONFIRM RECOVERY FROM NEUROMUSCULAR BLOCK.

NIMBEX HAS NO KNOWN EFFECT ON CONSCIOUSNESS, PAIN THRESHOLD, OR CEREBRATION. TO AVOID DISTRESS TO THE PATIENT, NEUROMUSCULAR BLOCK SHOULD NOT BE INDUCED BEFORE UNCONSCIOUSNESS.

NIMBEX Injection is acidic (pH 3.25 to 3.65) and may not be compatible with alkaline solutions having a pH greater than 8.5 (e.g., barbiturate solutions).

The 10 mL multiple-dose vials of NIMBEX contain benzyl alcohol, which is potentially toxic when administered locally to neural tissue. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solution containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources. Single-use vials (5 mL and 20 mL) of NIMBEX do not contain benzyl alcohol (see WARNINGS and PRECAUTIONS - Pediatric Use).

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Cisatracurium Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Cisatracurium Postmarketing Experience in the drug label.

Drug Interactions

Drug Interactions

NIMBEX has been used safely following varying degrees of recovery from succinylcholine-induced neuromuscular block. Administration of 0.1 mg/kg (2 × ED95) NIMBEX at 10% or 95% recovery following an intubating dose of succinylcholine (1 mg/kg) produced ≥ 95% neuromuscular block. The time to onset of maximum block following NIMBEX is approximately 2 minutes faster with prior administration of succinylcholine. Prior administration of succinylcholine had no effect on the duration of neuromuscular block following initial or maintenance bolus doses of NIMBEX. Infusion requirements of NIMBEX in patients administered succinylcholine prior to infusions of NIMBEX were comparable to or slightly greater than when succinylcholine was not administered.

The use of NIMBEX before succinylcholine to attenuate some of the side effects of succinylcholine has not been studied.

Although not studied systematically in clinical trials, no drug interactions were observed when vecuronium, pancuronium, or atracurium were administered following varying degrees of recovery from single doses or infusions of NIMBEX.

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 of NIMBEX and decrease the required infusion rate of NIMBEX. 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 NIMBEX and therefore, no adjustment to the initial dose should be necessary when NIMBEX 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 NIMBEX may be necessary. The average infusion rate requirement may be decreased by as much as 30% to 40%.

In clinical studies propofol had no effect on the duration of action or dosing requirements for NIMBEX.

Other drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as NIMBEX include certain antibiotics (e.g., aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, and sodium colistemethate), magnesium salts, lithium, local anesthetics, procainamide, and quinidine.

Resistance to the neuromuscular blocking action of nondepolarizing neuromuscular blocking agents has been demonstrated in patients chronically administered phenytoin or carbamazepine. While the effects of chronic phenytoin or carbamazepine therapy on the action of NIMBEX are unknown, slightly shorter durations of neuromuscular block may be anticipated and infusion rate requirements may be higher.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B Teratology testing in nonventilated pregnant rats treated subcutaneously with maximum subparalyzing doses (4 mg/kg daily; equivalent to 8 × the human ED95 following a bolus dose of 0.2 mg/kg IV) and in ventilated rats treated intravenously with paralyzing doses of NIMBEX at 0.5 and 1.0 mg/kg; equivalent to 10 × and 20 × the human ED95 dose, respectively, revealed no maternal or fetal toxicity or teratogenic effects. There are no adequate and well-controlled studies of NIMBEX in pregnant women. Because animal studies are not always predictive of human response, NIMBEX should be used during pregnancy only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cisatracurium in women who are pregnant.

Labor and Delivery

The use of NIMBEX during labor, vaginal delivery, or cesarean section has not been studied in humans and it is not known whether NIMBEX administered to the mother has effects on the fetus. Doses of 0.2 or 0.4 mg/kg cisatracurium given to female beagles undergoing cesarean section resulted in negligible levels of cisatracurium in umbilical vessel blood of neonates and no deleterious effects on the puppies. The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of toxemia of pregnancy

Nursing Mothers

It is not known whether cisatracurium besylate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised following administration of NIMBEX to a nursing woman.

Pediatric Use

NIMBEX has not been studied in pediatric patients below the age of 1 month (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION for clinical experience and recommendations for use in children 1 month to 12 years of age). Intubation of the trachea in patients 1-4 years old was facilitated more reliably when NIMBEX was used in combination with Halothane than when opioids and nitrous oxide were used for induction of anesthesia.

The 10 mL multiple-dose vials of NIMBEX contain benzyl alcohol as a preservative. Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome”, (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates. Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth-weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources.

Geriatic Use

Of the total number of subjects in clinical studies of NIMBEX, 57 were 65 and over, 63 were 70 and over, and 15 were 80 and over. The geriatric population included a subset of patients with significant cardiovascular disease (see CLINICAL PHARMACOLOGY - Hemodynamics Profile and Special Populations - Geriatric Patients subsections). No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger subjects, but greater sensitivity of some older individuals to NIMBEX cannot be ruled out.

Minor differences in the pharmacokinetics of cisatracurium between elderly and young adult patients are not associated with clinically significant differences in the recovery profile of NIMBEX following a single 0.1 mg/kg dose; the time to maximum block is approximately 1 minute slower in elderly patients (see CLINICAL PHARMACOLOGY - Pharmacokinetics).

Gender

There is no FDA guidance on the use of Cisatracurium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cisatracurium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cisatracurium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cisatracurium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cisatracurium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cisatracurium in patients who are immunocompromised.

Administration and Monitoring

Administration

Observed in Clinical Trials of Surgical Patients

Adverse experiences were uncommon among the 945 surgical patients who received NIMBEX 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 NIMBEX:

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 NIMBEX 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 NIMBEX 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 WARNINGS and PRECAUTIONS). There are rare reports of wheezing, laryngospasm, bronchospasm, rash and itching following administration of NIMBEX 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.

Monitoring

There is limited information regarding Cisatracurium Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Cisatracurium and IV administrations.

Overdosage

There is limited information regarding Cisatracurium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Cisatracurium Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Cisatracurium Mechanism of Action in the drug label.

Structure

There is limited information regarding Cisatracurium Structure in the drug label.

Pharmacodynamics

There is limited information regarding Cisatracurium Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Cisatracurium Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Cisatracurium Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Cisatracurium Clinical Studies in the drug label.

How Supplied

There is limited information regarding Cisatracurium How Supplied in the drug label.

Storage

There is limited information regarding Cisatracurium Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Cisatracurium Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Cisatracurium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Cisatracurium Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Cisatracurium Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.