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

There is limited information regarding Cisatracurium Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Cisatracurium in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cisatracurium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cisatracurium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cisatracurium in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Cisatracurium in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Cisatracurium in geriatric settings.

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

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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.