Medicinal Products


Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Atracurium besilate
laboratory: Faulding Pharmaceuticals

Injectable solution
Box of 1 bottle of 25 ml
All forms


Injectable atracurium besilate is indicated as an adjunct to general anesthesia during surgical procedures to release striated muscle and facilitate endotracheal intubation and assisted ventilation. It is also indicated to facilitate assisted ventilation in intensive care unit.

Dosage ATRACURIUM FAULDING 10 mg / ml Solution for injection Box of 1 bottle of 25 ml

- Atracurium besylate should be administered intravenously only. Atracurium besilate should not be used for intramuscular injection as it may cause tissue irritation and there is no clinical data available for this route of administration.
- In order to avoid causing anxiety to the patient, atracurium besylate will be administered only when the patient is unconscious. The injectable solution of atracurium besilate should not be mixed in the same syringe or administered simultaneously with the same needle to alkaline solutions (eg barbiturate solutions).
- As with all curars, monitoring of neuromuscular functions (monitoring) is recommended when using atracurium besilate to individually adjust the dosage.
- An initial dose of atracurium besilate of 0.3 to 0.6 mg / kg (depending on the duration of the desired curarization) administered as a bolus is recommended. It will provide sufficient relaxation for approximately 15 to 35 minutes.
- Endotracheal intubation is usually possible 90 to 120 seconds after intravenous injection of 0.5 to 0.6 mg / kg. Peak neuromuscular block is generally obtained 3 to 5 minutes after administration. The spontaneous recovery time after completion of complete block is approximately 35 minutes (recovery of neuromuscular function to 95% of normal).
- Although the effect of atracurium is potentiated (approximately 35%) by anesthesia with isoflurane or enflurane, an identical initial dose of atracurium besylate (0.3 to 0.6 mg / kg) may be administered for intubation provided its administration precedes that of these inhaled anesthetics. However, when the initial dose of atracurium is administered after stable anesthesia with isoflurane or enflurane, the dose of atracurium should be reduced by one-third. A lower dose reduction should be considered in case of concomitant halothane anesthesia, indeed, halothane weakly potentiates the action of atracurium (about 20%).
- Intermittent IV injection: During prolonged surgical procedures, neuromuscular blockade may be maintained by maintenance doses of 0.1 to 0.2 mg / kg of atracurium besilate. Generally, in case of balanced anesthesia, using maintenance doses of 0.1 mg / kg, the first dose is given 20 to 45 minutes after the initial bolus, then at 15 to 25 minute intervals, however Maintenance dose administration is determined by the individual needs and the patient's response. Administration of successive additional doses does not result in accumulation of neuromuscular blocking effect.
- Use in infusion: After an initial bolus of atracurium, neuromuscular block can be maintained, during prolonged surgical procedures, by continuous intravenous infusion of atracurium of 0.3 to 0.6 mg / kg / h. The infusion should be started only after spontaneous recovery after the initial bolus.
. Atracurium besylate solutions for infusion can be prepared by mixing the atracurium besylate solution for injection with a suitable dilution solvent (see below) to obtain an atracurium besylate concentration of 5 mg / ml.
. In cardiopulmonary surgery with extra-corporeal circulation, atracurium besylate may be administered as an infusion, using the recommended infusion rates. Hypothermia induced at 25-26 ° C reduces the rate of degradation of atracurium, therefore, complete neuromuscular block can be maintained by decreasing the infusion rate by approximately half.
- Compatibility with infusion fluids:
. The solution of injectable atracurium besylate diluted to 0.5 mg / ml with the following infusion fluids and stored at 30 ° C in the dark, is stable for the periods indicated below:
Infusion fluid: Duration of stability .
0.9% sodium chloride for IV infusion: 24 hours.
5% Glucose for IV infusion: 24 hours.
4% glucose and 0.18% sodium chloride for IV infusion: 24 hours.
Ringer USP solution: 24 hours.
Sodium lactate for IV infusion (Hartmann solution): 4 hours.
. Atracurium besylate solution for injection diluted to 5 mg / ml with the following infusion fluids and stored at 30 ° C, protected from light in 50 ml plastic syringes, is stable for the periods indicated below:
Infusion fluid: Duration of stability .
0.9% sodium chloride for IV infusion: 24 hours.
5% Glucose for IV infusion: 24 hours.
4% glucose and 0.18% sodium chloride for IV infusion: 24 hours.
Ringer USP solution: 24 hours.
Sodium lactate for IV infusion (Hartmann solution): 8 hours.
- The neuromuscular blockade induced by atracurium can be lifted by the administration of an anticholinesterase such as neostigmine or pyridostigmine, generally associated with an anticholinergic type atropine or glycopyrronium in order to prevent the muscarinic side effects of anticholinesterase. Under balanced anesthesia, reversion can usually be considered approximately 20 to 35 minutes after the initial dose of atracurium, or approximately 10 to 30 minutes after the last maintenance dose, when recovery of muscle contraction has begun. The complete reversion of the neuromuscular block is generally obtained 8 to 10 minutes after administration of the decuritizing agent.
- Rare cases of respiratory difficulty, probably due to incomplete reversion, have been reported after pharmacological reversion of neuromuscular blockade induced by atracurium. As with other products in this class, the risk of residual neuromuscular block is increased when block emergence is initiated at a deep block level or when insufficient doses of antagonistic agents are used.
- After an initial initial bolus of 0.3 to 0.6 mg / kg, neuromuscular blockade can be maintained by continuous infusion of atracurium besilate from 11 to 13 μg / kg / min (0.65 to 0, 78 mg / kg / h). There is great individual variability and the dosage may increase or decrease over time. Infusion rates as low as 4.5 μg / kg / min (0.27 mg / kg / h) or as high as 29.5 μg / kg / min (1.77 mg / kg / h) are required at some patients.
- The spontaneous recovery rate of neuromuscular blockade after infusion of atracurium besylate in an ICU patient is independent of the duration of administration.
- Spontaneous recovery to a T4 / T1> 0.75 (proportion of the height of the fourth stimulation to the first in a train of four) occurs approximately in 60 minutes. A range of 32 to 108 minutes was observed in clinical trials.
- Use in children: The dosage in children over one month is identical to that recommended in adults relative to body weight. Given the large individual variability of the neuromuscular response in children, neuromuscular monitoring is required.
- Use in the neonate: The available data are insufficient to recommend a dose in the newborn. However, this group of patients has increased sensitivity to non-depolarizing muscle relaxants and, therefore, it is recommended to reduce the doses in this group of patients.
- Use in the elderly: The standard dose of atracurium can be used in the elderly, however a slow injection is recommended.
- Use in patients with renal and / or hepatic insufficiency: No dosage modification is necessary regardless of the degree of renal or hepatic insufficiency, even at the end stage.
- Use in patients with cardiovascular disease: In severe cases, the initial dose of atracurium should be given as a slow injection of at least 60 seconds.
- See also warnings and precautions for use.

Against indications

- Known or suspected hypersensitivity to the product.
- Do not administer injectable atracurium besilate intramuscularly.
Pregnancy: Atracurium crosses the placental barrier, but no adverse effects have been identified in the fetus or newborn. Studies in animals have not shown any adverse effects of atracurium on fetal development. Like all neuromuscular blocking agents, the use of atracurium should be avoided during the first trimester of pregnancy; atracurium should not be used in the second and third trimester unless absolutely necessary. Anesthesia during the third trimester of pregnancy exposes the mother to Mendelson's syndrome (acid pneumopathy by inhalation of gastric juice). If a muscle relaxant is used to induce anesthesia, curare with a short duration of action, a short duration of action and a low transplacental passage should be preferred and should be used at a minimal dose to achieve relaxation. neuromuscular satisfactory. In patients receiving magnesium sulfate, reversion of the block may be unsatisfactory and the atracurium dose should be reduced as indicated.
- Breast-feeding: atracurium has a relatively high molecular weight and is highly ionized at physiological pH; these two factors strongly reduce the passage into milk. In addition, although the milk is slightly more acidic than plasma, the atracurium present in the milk would be rapidly degraded. However, given the potential risk of respiratory depression in neonates, particularly preterm infants, close monitoring of the neonate is recommended when breastfeeding begins within 24 hours after atracurium administration.

Adverse effects Atracurium Faulding

- As with most patients, there is a risk of adverse effects suggestive of histamine release in susceptible individuals.
- In clinical trials involving 875 patients, cases of redness of the skin have been reported in the range of 1% at doses up to 0.3 mg / kg and 29% at 0.6 mg doses / kg and more. The incidence of transient hypotension ranged from 1 to 14%, respectively, for the corresponding doses. Other adverse effects reported were: bronchospasm, tachycardia, and rarely, anaphylactoid reactions.
- In large-scale pharmacovigilance studies, adverse events considered to be in possible or probable relationship with atracurium were observed in approximately 10% of patients. Localized skin reactions, generalized flushing and hypotension have been observed in 2 to 3% of patients. Hypertension, tachycardia and bradycardia occurred in about 1% of patients. Bronchospasm has been reported in approximately 0.2% of patients.
- The following side effects have been reported for atracurium:
. General: Allergic reactions (ie anaphylactic or anaphylactoid type), severe in rare cases (eg shock, heart failure, cardiac arrest), Quincke's edema.
. Musculoskeletal: Insufficient block, prolonged block.
. Cardiovascular: Hypotension, hypertension, vasodilation (flushing), tachycardia, bradycardia, hypoxemia.
. Respiratory: Dyspnoea, bronchospasm, laryngospasm, wheezing.
. Dermatological: rash, urticaria, generalized erythema, redness of the skin, reaction at the injection site.
- Few cases of muscle weakness and / or myopathies have been observed following prolonged administration of atracurium besylate in critically ill patients in the intensive care unit. Most of them received concomitant corticosteroids. No causal link has been established with atracurium therapy.
Convulsions have been reported in rare cases in patients treated with atracurium in USI treated with several other drugs. These patients generally had one or more medical risk factors for seizures (eg head trauma, brain edema, viral encephalitis, hypoxic encephalopathy, uremia). In clinical trials, no correlation has been demonstrated between laudanosine plasma concentrations and convulsions.

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