Cisatracurium
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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
There is limited information regarding Cisatracurium Administration in the drug label.
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
{{#ask: Page Name::Cisatracurium |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Cisatracurium |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.