Medicinal Products

ATRACURIUM HOSPIRA 10 mg / mL

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
Active ingredients: Atracurium besylate
laboratory: Hospira

Injectable solution
Box of 1 bottle of 25 ml
All forms

Indication

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 HOSPIRA 10 mg / mL Solution for injection Box of 1 bottle of 25 ml

Adjuvant of general anesthesia

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 only be administered 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.

intubation

Initial bolus

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 besilate (0.3 to 0.6 mg / kg) can 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%).

Maintenance doses

Intermittent IV injection: During prolonged surgical procedures, neuromuscular blockade can be maintained with maintenance doses of 0.1 to 0.2 mg / kg of atracurium besilate. Generally, in the case of balanced anesthesia, using maintenance doses of 0.1 mg / kg, the first dose is administered 20-45 minutes after the initial bolus and then at 15-25 minute intervals; however, the administration of maintenance doses is determined by the individual needs and the patient's response. The administration of successive additional doses does not lead to an increase in neuromuscular blockade.

Use as an infusion: Following an initial bolus of atracurium, neuromuscular blockade can be maintained in prolonged surgical procedures by continuous intravenous infusion of intravenous infusion of 0.3 to 0.6 mg / kg / hr. 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 besilate 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. below.

Infusion fluid

Stability time

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

USP Ringer Solution

24 hours

Sodium lactate for iv infusion (Hartmann's solution)

4 hours

Atracurium besylate solution for injection diluted to 5 mg / ml with the following infusion liquids and stored at 30 ° C in the dark in 50 ml plastic syringes is stable for the periods indicated below. below:

Infusion fluid

Stability time

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

USP Ringer Solution

24 hours

Sodium lactate for iv infusion (Hartmann's solution)

8 hours

Reversion of neuromuscular block

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 atropine or glycopyrronium type 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 atracurium-induced neuromuscular blockade. 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.

Facilitation of assisted ventilation in intensive care unit patients

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.

Dosage adjustments

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 neonates: Use of atracurium is not recommended in neonates because of insufficient data available (see section 5.1 ).

Use in the elderly: the standard dose of atracurium may 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.

Adverse effects Atracurium Hospira

The undesirable effects are listed in descending order of frequency within each organ class system.

As with most curars, there is a risk of adverse effects suggestive of histamine release in susceptible individuals. In clinical trials (875 patients), skin redness has been reported in the range of 1% at doses up to 0.3 mg / kg and 29% at doses of 0.6 mg / kg and more. The incidence of transient hypotension ranged from 1 to 14%, respectively, for the corresponding doses.

Table of adverse reactions by frequency of Atracurium Hospira 10 mg / ml solution for injection

Classes of organ systems

Very common

(≥ 1/10)

Frequent

(≥ 1/100 to <1/10)

Rare

(≥ 1/1000 to <1/100)

Rare

(≥ 1/10 000 to <1/1000)

Very rare (<1 / 10, 000)

Not known (can not be estimated from the available data)

Heart conditions

Tachycardia, bradycardia (seen in 1% of patients)

Serious allergic reactions (eg shock, heart failure, cardiac arrest)

General disorders and administration site conditions

Reaction at the injection site

Immune system disorders

Allergic reactions (ie, anaphylactic or anaphylactoid responses) Anaphylactic-tooid reactions

Injury, poisoning and procedural complications

Extended block

Respiratory, thoracic and mediastinal disorders

Wheezing

Bronchospasm (0.2% of patients)

Dyspnoea, laryngo-spasm

hypoxemia

Bronchial secretions

Skin and subcutaneous tissue disorders

Localized skin reactions, rash, itching-sounds

Erythema generalized, urticaria

Quincke's edema, urticaria

Nervous system disorders

Insufficient block

Vascular disorders

Hypertension (seen in approximately 1% of patients)

Hypotension, vasodilatation (flushing) observed in approximately 2 to 3% of patients

A 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.

Seizures have been reported in rare cases in ICU patients treated with atracurium in combination 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, plasma laudanosine concentration has not been shown to correlate with convulsions.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

Popular Posts

Category Medicinal Products, Next Article