TRACRIUM is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

To avoid distress to the patient, TRACRIUM should not be administered before unconsciousness has been induced. TRACRIUM should not be mixed in the same syringe, or administered simultaneously through the same needle, with alkaline solutions (e.g., barbiturate solutions).

TRACRIUM should be administered intravenously. DO NOT GIVE TRACRIUM BY INTRAMUSCULAR ADMINISTRATION. Intramuscular administration of TRACRIUM may result in tissue irritation and there are no clinical data to support this route of administration.

As with other neuromuscular blocking agents, the use of a peripheral nerve stimulator will permit the most advantageous use of TRACRIUM, minimizing the possibility of overdosage or underdosage, and assist in the evaluation of recovery.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Bolus Doses for Intubation and Maintenance of Neuromuscular Block

Adults: A dose of TRACRIUM of 0.4 to 0.5 mg/kg (1.7 to 2.2 times the ED₉₅), given as an intravenous bolus injection, is the recommended initial dose for most patients. With this dose, good or excellent conditions for nonemergency intubation can be expected in 2 to 2.5 minutes in most patients, with maximum neuromuscular block achieved approximately 3 to 5 minutes after injection. Clinically required neuromuscular block generally lasts 20 to 35 minutes under balanced anesthesia. Under balanced anesthesia, recovery to 25% of control is achieved approximately 35 to 45 minutes after injection, and recovery is usually 95% complete approximately 60 minutes after injection.

TRACRIUM is potentiated by isoflurane or enflurane anesthesia. The same initial dose of TRACRIUM of 0.4 to 0.5 mg/kg may be used for intubation prior to administration of these inhalation agents; however, if TRACRIUM is first administered under steady state of isoflurane or enflurane, the initial dose of TRACRIUM should be reduced by approximately one third, i.e., to 0.25 to 0.35 mg/kg, to adjust for the potentiating effects of these anesthetic agents. With halothane, which has only a marginal (approximately 20%) potentiating effect on TRACRIUM, smaller dosage reductions may be considered.

Doses of TRACRIUM of 0.08 to 0.10 mg/kg are recommended for maintenance of neuromuscular block during prolonged surgical procedures. The first maintenance dose will generally be required 20 to 45 minutes after the initial injection of TRACRIUM, but the need for maintenance doses should be determined by clinical criteria. Because TRACRIUM lacks cumulative effects, maintenance doses may be administered at relatively regular intervals for each patient, ranging approximately from 15 to 25 minutes under balanced anesthesia, slightly longer under isoflurane or enflurane. Higher doses of TRACRIUM (up to 0.2 mg/kg) permit maintenance dosing at longer intervals.

Pediatric Patients: No dosage adjustments of TRACRIUM are required for pediatric patients 2 years of age or older. A dose of TRACRIUM of 0.3 to 0.4 mg/kg is recommended as the initial dose for infants (1 month to 2 years of age) under halothane anesthesia. Maintenance doses may be required with slightly greater frequency in infants and children than in adults.

Special Considerations: An initial dose of TRACRIUM of 0.3 to 0.4 mg/kg, given slowly or in divided doses over 1 minute, is recommended for adults, adolescents, children, or infants with significant cardiovascular disease and for adults, adolescents, children, or infants with any history (e.g., severe anaphylactoid reactions or asthma) suggesting a greater risk of histamine release.

Dosage reductions must be considered also in patients with neuromuscular disease, severe electrolyte disorders, or carcinomatosis in which potentiation of neuromuscular block or difficulties with reversal have been demonstrated. There has been no clinical experience with TRACRIUM in these patients, and no specific dosage adjustments can be recommended. No dosage adjustments of TRACRIUM are required for patients with renal disease.

An initial dose of TRACRIUM of 0.3 to 0.4 mg/kg is recommended for adults following the use of succinylcholine for intubation under balanced anesthesia. Further reductions may be desirable with the use of potent inhalation anesthetics. The patient should be permitted to recover from the effects of succinylcholine prior to administration of TRACRIUM . Insufficient data are available for recommendation of a specific initial dose of TRACRIUM for administration following the use of succinylcholine in children and infants.

Use by Continuous Infusion

Infusion in the Operating Room (OR): After administration of a recommended initial bolus dose of TRACRIUM (0.3 to 0.5 mg/kg), a diluted solution of TRACRIUM can be administered by continuous infusion to adults and pediatric patients aged 2 or more years for maintenance of neuromuscular block during extended surgical procedures.

Infusion of TRACRIUM should be individualized for each patient. The rate of administration should be adjusted according to the patient†s response as determined by peripheral nerve stimulation. Accurate dosing is best achieved using a precision infusion device.

Infusion of TRACRIUM should be initiated only after early evidence of spontaneous recovery from the bolus dose. An initial infusion rate of 9 to 10 mcg/kg per minute may be required to rapidly counteract the spontaneous recovery of neuromuscular function. Thereafter, a rate of 5 to 9 mcg/kg per minute should be adequate to maintain continuous neuromuscular block in the range of 89% to 99% in most pediatric and adult patients under balanced anesthesia. Occasional patients may require infusion rates as low as 2 mcg/kg per minute or as high as 15 mcg/kg per minute.

The neuromuscular blocking effect of TRACRIUM administered by infusion is potentiated by enflurane or isoflurane and to a lesser extent, by halothane. Reduction in the infusion rate of TRACRIUM should, therefore, be considered for patients receiving inhalation anesthesia. The infusion rate of TRACRIUM should be reduced by approximately one third in the presence of steady-state enflurane or isoflurane anesthesia; smaller reductions should be considered in the presence of halothane.

In patients undergoing cardiopulmonary bypass with induced hypothermia, the rate of infusion of TRACRIUM required to maintain adequate surgical relaxation during hypothermia (25° to 28° C) has been shown to be approximately half the rate required during normothermia.

Spontaneous recovery from neuromuscular block following discontinuation of infusion of TRACRIUM may be expected to proceed at a rate comparable to that following administration of a single bolus dose.

Infusion in the Intensive Care Unit (ICU): The principles for infusion of TRACRIUM in the OR are also applicable to use in the ICU.

An infusion rate of 11 to 13 mcg/kg per minute (range: 4.5 to 29.5) should provide adequate neuromuscular block in adult patients in an ICU. Limited information suggests that infusion rates required for pediatric patients in the ICU may be higher than in adult patients. There may be wide interpatient variability in dosage requirements and these requirements may increase or decrease with time (see PRECAUTIONS: Long-Term Use in Intensive Care Unit [ICU]). Following recovery from neuromuscular block, readministration of a bolus dose may be necessary to quickly re-establish neuromuscular block prior to reinstitution of the infusion.

Infusion Rate Tables

The amount of infusion solution required per minute will depend upon the concentration of TRACRIUM in the infusion solution, the desired dose of TRACRIUM, and the patient†s weight. The following tables provide guidelines for delivery, in mL/hr (equivalent to microdrops/min when 60 microdrops = 1 mL), of solutions of TRACRIUM in concentrations of 0.2 mg/mL (20 mg in 100 mL) or 0.5 mg/mL (50 mg in 100 mL) with an infusion pump or a gravity flow device.

Compatibility and Admixtures

Infusion solutions of TRACRIUM may be prepared by admixing TRACRIUM Injection with an appropriate diluent such as 5% Dextrose Injection, USP; 0.9% Sodium Chloride Injection, USP; or 5% Dextrose and 0.9% Sodium Chloride Injection, USP. Infusion solutions should be used within 24 hours of preparation. Unused solutions should be discarded. Solutions containing 0.2 mg/mL or 0.5 mg/mL TRACRIUM in the above diluents may be stored either under refrigeration or at room temperature for 24 hours without significant loss of potency. Care should be taken during admixture to prevent inadvertent contamination. Visually inspect prior to administration.

Spontaneous degradation of TRACRIUM has been demonstrated to occur more rapidly in Lactated Ringer†s solution than in 0.9% sodium chloride solution. Therefore, it is recommended that Lactated Ringer†s Injection, USP not be used as a diluent in preparing solutions of TRACRIUM for infusion.

TRACRIUM Injection, 10 mg atracurium besylate in each mL.

5-mL Single-Use Vial (50 mg atracurium besylate per vial). Tray of 10 (NDC 0173-0940-44).

10-mL Multiple-Dose Vial (100 mg atracurium besylate per vial). Contains benzyl alcohol (see WARNINGS). Tray of 10 (NDC 0173-0545-00).

STORAGE: TRACRIUM Injection should be refrigerated at 2° to 8° C (36° to 46° F) to preserve potency. DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25° C / 77° F), use TRACRIUM Injection within 14 days even if rerefrigerated.

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