Products information : ATRACURIUM 50mg

ATRACURIUM 50mg 50 mg Atracurium besylate
 
Products technical sheet

Form and presentation

Form
Injectable solution
Presentation
Box of 50 vials of 5ml
M.A number: 923 340 2H

Pharmacological class

Atracurium is a non depolarizing curare.

Composition

Atracurium besylate.......................................50mg
Excipients: sulfonic benzene acid............................s.q
W.F.I..........................................................s.q.f  5ml

Therapeutic indications

- Non depolarizing curare, adjuvant therapy in anesthesia permitting the induction and/or the maintaining of myorelaxation. It is adapted to all types of surgical interventions including pediatric, obstetrical and geriatric ones.
- Atracurium can be used as adjuvant for sedation in intensive care units in aim to relax striated muscles and to facilitate tracheal intubation and assisted ventilation.

Contra-indications

Atracurium is contraindicated in case of allergic history to Atracurium.

Warnings and precautions of use

Special Warnings
- Atracurium should be administered only by anesthetists or by practisers who are used to manage curare, or under their control. Intubation, assisted ventilation and arterial oxygenation appropriate equipments should be available when using curare.
- Like for all other curare, the monitoring of neuro-muscular functions is recommended in course of atracurium administration in aim to adjust the needs individually.
Precautions of use
- Atracurium should be used with caution in the following situations:
• Myasthenia (excessive tendency to muscular fatigue which can be progressive or occurring in a relapsing mode) or other neuro-muscular diseases and electrolytes disorders.
• Cardio-vascular insufficiency
• Persons with asthma or atopy
• History of allergy to other curare
- Atracurium is a hypotonic solution: do not infuse in the same tube with a blood transfusion.
Pregnancy and breastfeeding Pregnancy
Like all other curare, atracurium should be avoided during the first quarter and should only be used during the second and the third quarters in case of absolute necessity.
Breastfeeding
Atracurium does not pass in mother’s milk. It can be used for anesthesia in breastfeeding women. It is, however, recommended to suspend breastfeeding during 24 hours after atracurium administration.

Effects on the ability to drive or to operate on machines

It is not recommended to operate on machines potentially dangerous or to drive during the 24hours following atracurium administration.

Drugs interactions

Certain substances can modify the intensity and/or the duration of non depolarizing curare effects.
Drugs susceptible to major non depolarizing curare effects are:
- Halogen volatile anesthetics such as isoflurane, enflurane, desflurane, sevoflurane and halothane.
- Local anesthetics
- Certain antibiotics (aminosides, polymyxines, lincosamides, tetracyclines)
- Magnesium sulfate (I.V)
- Calcium channels blockers
- dantrolene
- Drugs which can reveal or worsen a myasthenia, or even produce a myasthenia syndrome such as quinidine, lithium, propanolol, injectable corticoids and telithromycine.
Drugs susceptible to diminish non depolarizing curare effects are:
- phenytoine and carbamazepine chronically administered
- Suxamethonium, administered in aim to prolong the non depolarizing curare effect, can provoke a complex block which is hard to antagonize with anti-cholinesterase agents.
- Theoretically, a monitoring maintained until complete decurarization can permit to manage all the interactions. However, a non expected recurarization can occur in case of post-operative antibiotic administration with an aminoside, for example.
Drugs requiring precautions of use:
- Aminnosides, colistine, lincosanides, polymyxine B: potentialization of curare when antibiotics are administered by parenteral or peritoneal route before, during or after the curare. The curarization level should be monitored at the end of anesthesia.
 Drugs to be taken into account:
Glucocorticoids I.V administration (except hydrocortisone for substitutive therapy): risk of severe myopathy, which can be reversible after a long time (several months).

Undesirable effects

Like all active product, atracurium can provoke in some patients some undesirable effects:
- Severe allergic reactions
- Cutaneous redness and eruptions
- Blood pressure lowering
- Exceptional brochospasm
- And even, an anaphylactic reaction
- Convulsions seizures: exceptionally and in case of prolonged use in reanimation in renal insufficient patients
- After a prolonged use of myorelaxing agents in patients in intensive care units, cases of muscular weakness or myopathy were reported.

Dosage and mode of administration

Dosage
The dosage of atracurium depends on the patient’s body weight, the intensity, the mode and the duration of intended curarization. The dosage should be adjusted according to the neuro-muscular monitoring.
Use in anesthesia:
Adults and children over than three months:
- Intravenous injection:
• A dose of 0.6mg/kg gives good intubation conditions in, generally, 2 minutes.
• 0.3 – 0.6mg/kg (according to the aimed curarization duration) induce a deep curarization of 15 – 35 minutes.
- Continuing infusion:
During prolonged surgical interventions, and after an initial bolus of 0.3 – 0.6mg/kg, atracurium, at the dose of 0.3 – 0.6mg/kg/h in continuing infusion, maintains an adequate neuro-muscular block.
Children less than three months:
- The doses of 0.3 – 0.6mg/kg in I.V injection or 0.3 – 0.6mg/kg/h in infusion, induce a longer curarization than in adults. It is recommended to adapt the dosage and to take into the account the large individual variability of response to curare in this age interval. The use of infusion requires a neuro-muscular monitoring.
- Under one month it is careful to reduce the dosage.
Use in reanimation
After an initial bolus of 0.3 – 0.6mg/kg, atracurium maintain an adequate neuro-muscular block in continuing infusion at the dose of 0.65 – 0.78mg/kg/h.
Mode of administration:
- Atracurium 50mg is administered by intravenous route in single injection or in continuing infusion.
- Atracurium should be not mixed in the same syringe to thiopental or to any other alkaline solution.

Overdose

Signs and symptoms
They consist in a prolonged muscular paralysis and its consequences.
Treatment
It is essential to maintain an artificial pulmonary ventilation until the recovery of an adequate spontaneous respiration. The total sedation is necessary; the vigilance is not being modified by atracurium. The recovery can be accelerated by the anti-cholinesterase agents combined to atropine, since the appearance of spontaneous recuperation first signs.

Storage

Atracurium 50  must be stored in a temperature between 2 and 8°C (in the refrigerator) and are to be kept away from light.
- Vials partially used should be discarded
- do not freeze

Delivery conditions

List I– table A, reserved to hospital use