Atracurium Besylate (Acuron injection): Complete Guide for Anesthesia and ICU Use.

 

(Atracurium Besylate Injection USP)

 

Composition:

Each ml contains

Atracurium Besylate USP …… 10.0mg

 

Description:

Acuron (Atracurium Besylate/injection USP) is an intermediate-acting competitive non-depolarizing, skeletal muscle relaxant for intravenous administration. Acuron (Atracurium Besylate erile,  nonpyrogenic aqueous solution. Each Injection USP) is a sterile, ml contains 10 mg Atracurium Besylate. The pH is adjusted to 3.25 to 3.65 with benzene sulfonic acid.

 

Clinical Pharmacology:

 

 Mechanism of action of Atracurium

Acuron (Atracurium Besylate Injection USP) is a non-depolarizing agent that antagonizes acetylcholine's neurotransmitter action by binding competitively with cholinergic receptor sites on the motor end-plate. The duration of neuromuscular blockade produced by Atracurium Besylate is approximately one-third to one-half the duration of blockade of d-tubocurarine and pancuronium at initially equipotent doses.

As with other non-depolarizing neuromuscular blockade, the time to onset of paralysis decreases and the duration of maximum effect increases with increasing Acuron doses.

Repeated administration of maintenance doses of Atracurium Besylate has no cumulative effect on the duration of neuromuscular blockade if recovery is allowed to begin before repeat dosing, moreover, the time needed to recover from repeat doses does not change with additional doses, suggested maintenance dose of 0.08 to 0.10 mg/kg is required within 20 to 45 minutes and subsequent doses with 15 - 25 minutes interval. Recovery from neuromuscular block (under balanced anesthesia) can be expected to begin approximately 20 to 35 minutes after injection. The neuromuscular blocking action of Acuron (Atracurium Besylate Injection USP) is enhanced in the presence of potent inhalation anesthetics. Reversal of neuromuscular block produced by 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.

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The pharmacokinetics of Acuron (Atracurium Besylate Injection USP) are linear within the 0.3 to 0.6 mg/kg dose range. The duration of neuromuscular blockade produced by Acuron does not correlate with plasma pseudocholinesterase level and is not altered in compromised renal function. The elimination half-life is approximately 20 minutes. Acuron (Atracurium Besylate Injection USP) is inactivated in plasma via two non-oxidation pathways: esterases and Hoffman elimination, a non-enzymatic chemical process.

   

Indications:

As an adjunct to General Anesthesia.

To facilitate endotracheal intubation.

To provide skeletal muscle relaxation during surgery or ventilation.

Off-Label Uses

The use of Atracurium in conjunction with vecuronium significantly lengthens the period of deep neuromuscular blockade during laparoscopic cholecystectomy, potentially benefiting surgeries that require sustained muscle relaxation. Importantly, atracurium does not impact the onset of action, intubation conditions, or the time needed for reversal, making it an effective option for improving neuromuscular management in these operations. However, further studies are necessary [1].

Controlling intracranial pressure (ICP) is a critical aspect of managing traumatic brain injury (TBI), and neuromuscular blocking agents (NMBAs) like atracurium may prove useful in controlling ICP during procedures. However, the ongoing use of NMBAs, such as atracurium, may introduce risks, including prolonged high ICP and complications beyond the cranial region, indicating a need for further study [2].

According to research findings, atracurium is a safe and equally effective option compared to cisatracurium for patients with acute respiratory distress syndrome (ARDS). It also offers financial benefits while achieving similar levels of efficacy. A dosage of 1 mg/kg of atracurium is optimal for ensuring effective intubating conditions during rapid sequence induction of anesthesia, with a high success rate and minimal coughing or bucking. This dosage significantly enhances the paralysis of both the vocal cords and diaphragm relative to lower doses [3].

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Dosage and Administration:

To avoid distress to the patients, Acuron (Atracurium Besylate Injection USP) should not be administered before unconsciousness has been induced. Acuron (Atracurium Besylate Injection USP) should not be mixed in the same syringe with alkaline solutions.

Adults:

Acuron (Atracurium Besylate Injection USP) Injection in a dose of 0.4 to 0.5 mg/kg given as an intravenous bolus injection, is the recommended initial dose for most patients. With this dose, non-emergency intubations can be expected in 2 to 2.5 minutes in most patients, with maximum neuromuscular block achieved approximately 3 to 5 minutes after injection. Acuron Injection is potentiated by inhalational anaesthetics.

   

Maintenance Dose:

Acuron (Atracurium Besylate Injection USP) in doses 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, but the need for maintenance doses should be determined by clinical criteria.

 

Pediatric (Children/Infants) Patients:

Acuron (Atracurium Besylate Injection USP) in a dose 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 anaesthesia. Maintenance doses may be required with slightly greater frequency in infants and children than in adults. No dosage adjustments are required for pediatric patients 2 years of age or older.

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Dosage under Special Conditions:

Acuron (Atracurium Besylate Injection USP) in a dose of 0.3 to 0.4mg/kg, given slowly or in divided doses over one minute, is recommended for adults, adolescents, children, or infants with significant cardiovascular disease and severe anaphylactoid reactions or asthma suggesting a greater risk of histamine release. Dosage reductions must be considered in patients with neuromuscular disease, severe electrolyte disorders, or carcinomatosis in which potentiation of neuromuscular block or difficulties with reversal have been demonstrated.

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Dosage by Continuous Infusion in OT & ICUs:

After administration of a recommended initial bolus dose of Acuron (Atracurium Besylate Injection USP) in a dose of 0.3 to 0.5 mg/kg, a diluted solution of Acuron (Atracurium Besylate Injection USP) 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 and in ICU’s.

Infusion 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.

An initial infusion rate of 9 to 10 mcg/kg per minute may be of neuromuscular function. Thereafter, a rate of 5 to 9mcg/kg per minute should be adequate to maintain continuous neuromuscular block.

Occasional patients may require infusion rates as low as 2 mcg/kg per minute or as high as 15 mcg/kg per minute.

The rate of Atracurium Besylate Injection infusion should be reduced by approximately one third in the presence of inhalation anaesthetics.

 

Contraindications:

Acuron (Atracurium Besylate Injection USP) is contraindicated in patients known to have a hypersensitivity to it.

 

Side Effects:

Acuron is well tolerated and produces little adverse reaction during extensive clinical trials.

 

General – Allergic reactions (anaphylactic or anaphylactoid response).

CNS – hypotension, vasodilation, tachycardia, bradycardia. Respiratory Dyspnea, bronchospasm, and laryngospasm.

 

Precautions:

Acuron (Atracurium Besylate Injection USP) is a less potent histamine releaser than d-tubocurarine or metocurine. Special caution should be exercised in administering Acuron (Atracurium Besylate Injection USP) to patients with significant cardiovasculardisease and in patients with any history severe anaphylactoid reactions or asthma, suggesting a greater risk of histamine release.

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Since Acuron (Atracurium Besylate Injection USP) has no clinically significant effects on heart rate in the recommended dosage range as a result, bradycardia during anaesthesia may be more common with Acuron (Atracurium Besylate Injection USP) than with other muscle relaxants.

Acuron (Atracurium Besylate Injection USP) may have profound effects in patients with myasthenia gravis, Eaton-Lambert syndrome, or other neuromuscular diseases in which potentiation of non-depolarizing agents has been noted. The use of a peripheral nerve stimulator is especially important for assessing neuromuscular block in these patients. Similar precautions should be taken in patients with severe electrolyte disorders or carcinomatosis.

Hemofiltration has a minimal effect on plasma levels of atracurium and its metabolites, including audanosine. The effects of hemodialysis and hemoperfusion on plasma levels of Acuron (Atracurium Besylate Injection USP) and its metabolites are unknown.

   

Warnings:

Atracurium Besylate Injection USP 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. Anticholinesterase reversal agents should be immediately available. Do not give Acuron (Atracurium Besylate Injection USP) Injection by intramuscular administration.

Acuron (Atracurium Besylate Injection USP), which has an acidic 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.

 

Use in Special Situations:

Acuron (Atracurium Besylate Injection USP) is Pregnancy Category C. No harmful effects were attributable to Atracurium Besylate Injection in any of the neonates, although small amounts of Atracurium Besylate were shown to cross the placental barrier. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Acuron (Atracurium Besylate Injection USP) is administered to a nursing woman.

 

Overdose:

 

There has been limited experience with Acuron (Atracurium Besylate Injection USP) overdosage. The possibility of iatrogenic overdosage can be minimized by carefully monitoring the muscle twitch response to peripheral nerve stimulation. Excessive doses of Atracurium Besylate Injection can be expected to produce enhanced pharmacological effects. An overdose may increase the risk of histamine release and cardiovascular effects, especially hypotension.

 

Storage:

Store in refrigerator at 2-8°C. DO NOT FREEZE. Upon removal from the refrigerator to room temperature (25°C), use Acuron (Atracurium Besylate Injection USP) within 14 days even if re-refrigerated.

 

Presentation:

Acuron (Atracurium Besylate Injection USP) Injection IV is available in 5x3ml (30mg/Ampoule) and 5x5ml (50mg/Ampoule) Packs.

 

Enhancing Healthcare Team Outcomes

Pharmacists are responsible for identifying possible drug interactions and recommending necessary adjustments to dosages. Nurses must monitor the patient's condition and inform the Certified Registered Nurse Anesthetist (CRNA) of any complications that arise. Close observation of patients in the Medical Intensive Care Unit (MICU), Surgical Intensive Care Unit (SICU), and Post-Anesthesia Care Unit (PACU) is imperative for both nurses and residents. A significant retrospective cohort study has shown notable differences among providers in the application of neuromuscular blocking agents (NMBAs) during general anesthesia, with CRNAs adapting their practices to align more closely with the preferences of individual surgeons. This finding emphasizes the necessity for standardized guidelines to optimize the use of NMBAs, enhance patient safety, and improve clinical outcomes through better collaboration among healthcare professionals.

References:

1.      Sanfilippo F, Santonocito C, Veenith T, Astuto M, Maybauer MO. The role of neuromuscular blockade in patients with traumatic brain injury: a systematic review. Neurocrit Care. 2015 Apr;22(2):325-34.
2.       Reshmika P, Dutta A, Malhotra S, Sethi N, Sood J. Efficacy of Atracurium-Vecuronium Combination in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Study. Asian J Anesthesiol. 2023 Dec 01;61(4):153-160.
3.      Carabetta SM, Allen B, Cannon C, Hailu K, Johnson T. Atracurium Versus Cisatracurium in the Treatment of Acute Respiratory Distress Syndrome. J Pharm Technol. 2023 Oct;39(5):212-217.
4.      .  Althoff FC, Xu X, Wachtendorf LJ, Shay D, Patrocinio M, Schaefer MS, Houle TT, Fassbender P, Eikermann M, Wongtangman K. Provider variability in the intraoperative use of neuromuscular blocking agents: a retrospective multicentre cohort study. BMJ Open. 2021 Apr 14;11(4):e048509

 

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