Atravell

Atravell

atracurium besilate

Manufacturer:

Prosweal Healthcare

Distributor:

Prosweal Healthcare
Full Prescribing Info
Contents
Atracurium besilate.
Description
Each mL contains: Atracurium besilate 10 mg.
Action
Pharmacology: Atracurium is a competitive nondepolarising neuromuscular agent which acts by competing with acetylcholine for occupancy of receptor sites are blocked Atracurium resulting in failure of contraction and eventual flaccid paralysis.
Indications/Uses
Used for endotracheal intubation and to provide muscle relaxation in general anaesthesia for surgical procedures and to aid controlled ventilation.
Dosage/Direction for Use
Use by injection in Adults: Atracurium is administered by IV injection.
Dosage Range for Adults: 0.3-0.6 mg/kg (depending on the duration of full block required) and will provide relaxation for about 15-35 min.
Endotracheal intubation can usually be accomplished within 90 seconds from Intravenous injection of 0.5-0.6 mg/kg.
Full block can be prolonged with supplementary doses of 0.1-0.2 mg/kg as required. Successive supplementary dosing does not give rise to accumulation of neuromuscular-blocking effect. Spontaneous recovery from the end of full block occurs in 35 min as measured by the restoration of the tetanic response of 95% of normal neuromuscular function. The neuromuscular block produced by Atracurium can be rapidly reversed by standard doses of anticholinesterase agents, e.g. neostigmine and edrophonium, accompanied or preceded by atropine, with no evidence of re-curarisation.
Use as an infusion in Adults: After an initial bolus dose of 0.3-0.6 mg/kg, Atracurium can be used to maintain neuromuscular block during long surgical procedures by administration as continuous infusion at rates 0.3-0.6 mg/kg/hr. Atracurium can be administered by infusion during cardiopulmonary bypass surgery at the recommended infusion rates. Induced hypothermia to a body temperature of 25-26°C by maintained approximately half the original infusion rate at these low temperatures. Atracurium is compatible with the following infusion solutions for the times stated in the table. (See table.)

Click on icon to see table/diagram/image

When diluted in these solutions to give Atracurium besylate concentration of not more than 0.5 mg/mL, the resultant solutions will be stable in daylight for the stated periods at the temperatures of up to 30°C.
Children: The dosage in children more than 1 month is the same as that in adult on a body weight basis.
Elderly: Atracurium may be used a standard dosage in elderly patients. It is recommended, however, that the initial dose be at the lower end of the range and that it be administered slowly.
Patients with Reduced Renal and/or Hepatic Function: Atracurium may be used at standard dosage at all levels of renal or hepatic function, including end-stage failure.
Patients with Cardiovascular Disease: In patients with clinically significant cardiovascular disease, the initial dose of Atracurium should be administered over a period of 60 sec.
Intensive Care Unit (ICU) patients: After an optional initial bolus dose of 0.3-0.6 mg/kg, Atracurium can be used to maintain neruomuscular block by administering a continuous infusion at rates of between 11 and 13 μg/kg/min (0.65-0.78 mg/kg/hr). However, there is wide inter-patient variability in dosage requirements. Dosage requirements may change with time. Infusion rates as low as 4.5 μg/kg/min (0.27 mg/kg/hr) or as high as 29.5 μg/kg/min (1.77 mg/kg/hr) are required in some patients. The rate of spontaneous recovery from neuromuscular block after infusion of Atracurium in ICU patients is independent of the duration of administration. Spontaneous recovery to a train-of-four ration >0.75 (the ratio of the height of the 4th to the 1st twitch in a train-of-four) can be expected to occur in approximately 60 min. A range of 32-108 min has been observed in clinical trials.
Monitoring: In common with all the neuromuscular-blocking agents, monitoring of neuromuscular function is recommended during the use of Atracurium in order to individual dosage requirements.
Overdosage
Symptoms: Prolonged muscle paralysis and its consequences are the main signs of overdosage.
Treatment: It is essential to maintain a patent airway together with assisted positive pressure ventilation until spontaneous respiration is adequate. Full sedation will be required since consciousness is not impaired. Recovery may be hastened by the administration of anticholinesterase agents accompanied by atropine or glycopyrrolate, once evidence of spontaneous recovery is present.
Contraindications
Patients known to have an allergic hypersensitivity to Atracurium.
Special Precautions
In common with all other neuromuscular-blocking agents, Atracurium paralyses the respiratory muscles as well as other skeletal muscles, but has no effect on consciousness. Atracurium should be administered only with adequate general anaesthesia and only by or under the close supervision of an experience anaesthetist with adequate facilities for endotracheal intubation and artificial ventilation.
In common with other nondepolarising neuromuscular-blocking agents, increased sensitivity to Atracurium may be expected in patients with myasthenia gravis, other forms of neuromuscular disease and severe electrolyte imbalance.
Atracurium should be administered over a period of 60 sec to patients who may be unusually sensitive to fall in arterial blood pressure, e.g. those who are hypovolaemic. When a small vein is selected as the injection side, Atracurium should be flushed through the vein with physiological saline after injection. When other anaesthetic drugs are administered through the same in dwelling needle or cannula as Atracurium is important that each drug is flushed through with an adequate volume of physiological saline.
Atracurium besylate is hypotonic and must not be administered into the infusion line of blood transfusion.
Studies is malignant hyperthermia in susceptible animals (swine) and clinical studies in patients susceptible to malignant hyperthermia indicate that Atracurium, does not trigger this syndrome. In common with other nondepolarising neuromuscular-blocking agents, resistance may develop in patients suffering from burns. Such patients may require increased doses dependent on the time elapsed since the burn injury and the extent of the burn.
Carcinogenicity, Mutagenicity and Impairment of Infertility: Atracurium has been evaluated in 3 short-term mutagenicity tests. It was not mutagenic in either the in vitro Ames salmonella assay at concentrations up to 1000 μg/plate or in an in vivo rat bone marrow assay at doses up to those which resulted in neuromuscular blockade. In a 2nd in vitro test, the mouse lymphoma assay, mutagenicity was not observed at doses up to 60 μg/mL which killed up to 50% of the treated cell, but was moderately mutagenic at concentrations of 80 μg/mL in the absence of metabolising agent, and weakly mutagenic at very high concentrations (1200 μg/mL) when metabolising enzymes were added. At both concentrations, >80% of the cells were killed.
In view of the nature of human exposure to Atracurium, the mutagenic risk to patients undergoing surgical relaxation with Atracurium must be considered negligence. Fertility studies have not been performed.
Use in Pregnancy & Lactation: In common with all neuromuscular-blocking agents, Atracurium should be used during pregnancy only if the potential benefit to the mother outweighs any potential risk to the foetus.
Atracurium is suitable for maintenance of muscle relaxation during caesarian section as it does not cross the placenta in clinically significant amounts following recommended doses.
It is not known whether Atracurium is excreted in human milk.
Atracurium besylate is inactivated by high pH and so must not be mixed in the same syringe with Thiopentone or any alkaline agent.
Use In Pregnancy & Lactation
In common with all neuromuscular-blocking agents, Atracurium should be used during pregnancy only if the potential benefit to the mother outweighs any potential risk to the foetus.
Atracurium is suitable for maintenance of muscle relaxation during caesarian section as it does not cross the placenta in clinically significant amounts following recommended doses.
It is not known whether Atracurium is excreted in human milk.
Atracurium besylate is inactivated by high pH and so must not be mixed in the same syringe with Thiopentone or any alkaline agent.
Adverse Reactions
Associated with the use of Atracurium, there have been reports of skin flushing, mild transient hypotension or bronchospasm, which have been attributed to histamine release. Very rarely, severe anaphylactoid reactions have been reported in patients receiving Atracurium in conjunction with one or more anaesthetic agents. There have been rate reports of seizures in ICU patients who have been receiving Atracurium concurrently with several agents. These patients usually had one or more medical conditions predisposing to seizures (e.g. cranial trauma, cerebral edema, viral encephalitis, hypoxic encephalopathy, uraemia). On clinical trials, there appears to be no correlation between plasma laudanosine concentration and the occurrence of seizures. There have been some reports of muscle weakness and/or myopathy following prolonged use of muscle relaxants in severely ill patients in the ICU. Most patients were receiving concomitant corticosteroids. These events have been seen infrequently in association with Atracurium. A casual relationship has not been established.
Drug Interactions
The neuromuscular block produced by Atracurium may be increased by the concomitant use of inhalation anaesthetics, e.g halothane, isoflurane and enflurane. In common with all the nondepolarising neuromuscular-blocking agents, the magnitude and/or duration of a nondepolarising neuromuscular block may be increased as a result of interaction with: Antibiotics, including aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin and clindamycin.
Antiarrhythmic Drugs: propanolol, calcium-channel blockers, lignocaine, procainamide, and quinidine.
Diuretics: Furosemide and possibly mannitol, thiazide diuretics and acetazolamide.
Magnesium sulfate, ketamine, Lithium salts.
Ganglion-blocking agents: Trimetaphan, hexamethonium.
Rarely, certain drugs may aggravate or unmask latent myasthenia gravis or actually induce a myasthenic syndrome; increased sensitivity to Atracurium would be consequent on such a development. Such drugs (procainamide, quinidine), antirheumatic drugs (chloroquine, D-penicillamine), trimetaphan, chlorpromazine, steroids, phenytoin and lithium. The onset of nondepolarising neuromuscular block is likely to be lengthened and the duration of block shortened in patients receiving chronic anticonvulsant therapy. The administration of combinations nondepolarising neuromuscular-blocking agents in conjunction with Atracurium may produce a degree of neuromuscular blockade in excess of that which might be expected were an equipotent total dose of Atracurium was administered. Any synergistic effect may vary between different drug combinations. A depolarising muscle relaxant, e.g suxamethonium chloride should not be administered to prolong the neuromuscular blocking effects of nondepolarising agents, e.g. Atracurium, as this may result in a prolonged and complex block which can be difficult to reverse with anticholinesterase drugs.
Caution For Usage
Atracurium is inactivated by high pH and so must not mixed in the same syringe with thiopentone or any alkaline agent. When a small vein is selected as the injection site. Atracurium should be flushed through the vein with physiological saline after injection. When other anaesthetic drugs are administered through the same in-dwelling needle or cannula as Atracurium, it is important that each drug is flushed through with an adequate volume of physiological saline.
Storage
Store between 2-8°C to preserve potency. Do not freeze.
Upon removal from refrigerator to room temperature storage conditions (below 30°C), use Atracurium injection within 14 days even if refrigerated. For single use.
ATC Classification
M03AC04 - atracurium ; Belongs to the class of other quaternary ammonium-containing agents used as peripherally-acting muscle relaxants.
Presentation/Packing
Soln for inj (amp) 10 mg/mL x 2.5 mL x 5's, 5 mL x 5's.
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