- Tracrium mg
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- Tracrium 10 mg
- Tracrium tracrium injection
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Solution: D5/NS, D5W(?), NS(?)
Additive: bretylium, cimetidine, ciprofloxacin, dobutamine, dopamine, esmolol, gentamicin, isoproterenol, lidocaine, morphine, KCl, procainamide, vancomycin
Syringe: alfentanil, fentanyl, midazolam, sufentanil
Y-site: amiodarone, cefazolin, cefuroxime, cimetidine, clarithromycin, dobutamine, dopamine, epinephrine, esmolol, etomidate, fenoldopam, fentanyl, gentamicin, heparin, Hextend, hydrocortisone, isoproterenol, lorazepam, midazolam, milrinone, morphine, nitroglycerin, ranitidine, Na nitroprusside, trimethoprim/sulfamethoxazole, vancomycin
Additive: aminophylline, cefazolin, heparin, quinidine gluconate, ranitidine, sodium nitroprusside
Syringe: alkaline solutions
Y-site: diazepam, propofol(?), thiopental
Add to an empty Viaflex bag & infuse undiluted (10 mg/mL); however, if necessary, may be diluted in D5W, NS or dextrose-saline combinations
Dilution in LR not recommended
Not for IM injection due to tissue irritation
May be given undiluted as bolus injection
Administration via infusion requires use of an infusion pump
Use infusion solutions within 24 hr of preparation
Unstable in alkaline solutions
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 (atracurium besylate) 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 (atracurium besylate) Injection within 14 days even if rerefrigerated.
TRACRIUM (atracurium besylate) SHOULD BE USED ONLY BY THOSE SKILLED IN AIRWAY MANAGEMENT AND RESPIRATORY SUPPORT. EQUIPMENT AND PERSONNEL MUST BE IMMEDIATELY AVAILABLE FOR ENDOTRACHEAL INTUBATION AND SUPPORT OF VENTILATION, INCLUDING ADMINISTRATION OF POSITIVE PRESSURE OXYGEN. ADEQUACY OF RESPIRATION MUST BE ASSURED THROUGH ASSISTED OR CONTROLLED VENTILATION. ANTICHOLINESTERASE REVERSAL AGENTS SHOULD BE IMMEDIATELY AVAILABLE.
DO NOT GIVE TRACRIUM (atracurium besylate) BY INTRAMUSCULAR ADMINISTRATION. TRACRIUM (atracurium besylate) has no known effect on consciousness, pain threshold, or cerebration. It should be used only with adequate anesthesia.
TRACRIUM ® (atracurium besylate) Injection, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions) in the same syringe or administered simultaneously during intravenous infusion through the same needle. Depending on the resultant pH of such mixtures, TRACRIUM (atracurium besylate) may be inactivated and a free acid may be precipitated.
TRACRIUM (atracurium besylate) Injection 10-mL multiple-dose vials contain benzyl alcohol. In neonates, benzyl alcohol has been associated with an increased incidence of neurological and other complications which are sometimes fatal. TRACRIUM (atracurium besylate) Injection 5-mL single-use vials do not contain benzyl alcohol (see
TRACRIUM (atracurium besylate) is a nondepolarizing skeletal muscle relaxant. Nondepolarizing agents antagonize the neurotransmitter action of acetylcholine by binding competitively with cholinergic receptor sites on the motor end-plate. This antagonism is inhibited, and neuromuscular block reversed, by acetylcholinesterase inhibitors such as neostigmine, edrophonium, and pyridostigmine.
TRACRIUM (atracurium besylate) can be used most advantageously if muscle twitch response to peripheral nerve stimulation is monitored to assess degree of muscle relaxation.
The duration of neuromuscular block produced by TRACRIUM (atracurium besylate) is approximately one third to one half the duration of block by d-tubocurarine, metocurine, and pancuronium at initially equipotent doses. As with other nondepolarizing neuromuscular blockers, the time to onset of paralysis decreases and the duration of maximum effect increases with increasing doses of TRACRIUM (atracurium besylate) .
The ED95 (dose required to produce 95% suppression of the muscle twitch response with balanced anesthesia) has averaged 0.23 mg/kg (0.11 to 0.26 mg/kg in various studies). An initial dose of TRACRIUM (atracurium besylate) of 0.4 to 0.5 mg/kg generally produces maximum neuromuscular block within 3 to 5 minutes of injection, with good or excellent intubation conditions within 2 to 2.5 minutes in most patients. Recovery from neuromuscular block (under balanced anesthesia) can be expected to begin approximately 20 to 35 minutes after injection. 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 to 70 minutes after injection. The neuromuscular blocking action of TRACRIUM (atracurium besylate) is enhanced in the presence of potent inhalation anesthetics. Isoflurane and enflurane increase the potency of TRACRIUM (atracurium besylate) and prolong neuromuscular block by approximately 35%; however, halothane†s potentiating effect (approximately 20%) is marginal (see DOSAGE AND ADMINISTRATION).
Repeated administration of maintenance doses of TRACRIUM (atracurium besylate) has no cumulative effect on the duration of neuromuscular block if recovery is allowed to begin prior to repeat dosing. Moreover, the time needed to recover from repeat doses does not change with additional doses. Repeat doses can therefore be administered at relatively regular intervals with predictable results. After an initial dose of 0.4 to 0.5 mg/kg under balanced anesthesia, the first maintenance dose (suggested maintenance dose is 0.08 to 0.10 mg/kg) is generally required within 20 to 45 minutes, and subsequent maintenance doses are usually required at approximately 15- to 25-minute intervals.
Once recovery from the neuromuscular blocking effects of TRACRIUM (atracurium besylate) begins, it proceeds more rapidly than recovery from d-tubocurarine, metocurine, and pancuronium. Regardless of the dose of TRACRIUM (atracurium besylate) , the time from start of recovery (from complete block) to complete (95%) recovery is approximately 30 minutes under balanced anesthesia, and approximately 40 minutes under halothane, enflurane, or isoflurane. Repeated doses have no cumulative effect on recovery rate.
Reversal of neuromuscular block produced by TRACRIUM (atracurium besylate) can be achieved with an anticholinesterase agent such as neostigmine, edrophonium, or pyridostigmine, in conjunction with an anticholinergic agent such as atropine or glycopyrrolate. Under balanced anesthesia, reversal can usually be attempted approximately 20 to 35 minutes after an initial dose of TRACRIUM (atracurium besylate) of 0.4 to 0.5 mg/kg, or approximately 10 to 30 minutes after a 0.08- to 0.10-mg/kg maintenance dose, when recovery of muscle twitch has started. Complete reversal is usually attained within 8 to 10 minutes of the administration of reversing agents. Rare instances of breathing difficulties, possibly related to incomplete reversal, have been reported following attempted pharmacologic antagonism of neuromuscular block induced by TRACRIUM (atracurium besylate) . As with other agents in this class, the tendency for residual neuromuscular block is increased if reversal is attempted at deep levels of block or if inadequate doses of reversal agents are employed.
The pharmacokinetics of TRACRIUM (atracurium besylate) in humans are essentially linear within the 0.3- to 0.6-mg/kg dose range. The elimination half-life is approximately 20 minutes. THE DURATION OF NEUROMUSCULAR BLOCK PRODUCED BY TRACRIUM (atracurium besylate) DOES NOT CORRELATE WITH PLASMA PSEUDOCHOLINESTERASE LEVELS AND IS NOT ALTERED BY THE ABSENCE OF RENAL FUNCTION. This is consistent with the results of in vitro studies which have shown that TRACRIUM (atracurium besylate) is inactivated in plasma via two nonoxidative pathways: ester hydrolysis, catalyzed by nonspecific esterases; and Hofmann elimination, a nonenzymatic chemical process which occurs at physiological pH. Some placental transfer occurs in humans.
Radiolabel studies demonstrated that TRACRIUM (atracurium besylate) undergoes extensive degradation in cats, and that neither kidney nor liver plays a major role in its elimination. Biliary and urinary excretion were the major routes of excretion of radioactivity (totaling >90% of the labeled dose within 7 hours of dosing), of which TRACRIUM (atracurium besylate) represented only a minor fraction. The metabolites in bile and urine were similar, including products of Hofmann elimination and ester hydrolysis.
Elderly patients may have slightly altered pharmacokinetic parameters compared to younger patients, with a slightly decreased total plasma clearance which is offset by a corresponding increase in volume of distribution. The net effect is that there has been no significant difference in clinical duration and recovery from neuromuscular block observed between elderly and younger patients receiving TRACRIUM (atracurium besylate) .
TRACRIUM (atracurium besylate) is a less potent histamine releaser than d-tubocurarine or metocurine. Histamine release is minimal with initial doses of TRACRIUM (atracurium besylate) up to 0.5 mg/kg, and hemodynamic changes are minimal within the recommended dose range. A moderate histamine release and significant falls in blood pressure have been seen following 0.6 mg/kg of TRACRIUM (atracurium besylate) . The histamine and hemodynamic responses were poorly correlated. The effects were generally short-lived and manageable, but the possibility of substantial histamine release in sensitive individuals or in patients in whom substantial histamine release would be especially hazardous (e.g., patients with significant cardiovascular disease) must be considered.
It is not known whether the prior use of other nondepolarizing neuromuscular blocking agents has any effect on the activity of TRACRIUM (atracurium besylate) . The prior use of succinylcholine decreases by approximately 2 to 3 minutes the time to maximum block induced by TRACRIUM (atracurium besylate) , and may increase the depth of block. TRACRIUM (atracurium besylate) should be administered only after a patient recovers from succinylcholine-induced neuromuscular block.
See WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS.
© Tracrium Patient Information is supplied by Cerner Multum, Inc. and Tracrium Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
Nondepolarizing neuromuscular blocking agent.1
Advice to Patients
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease, neuromuscular disease).1
Importance of informing patients of other important precautionary information.1 (See Cautions.)