Atracade™ (Atracurium besylate) is a an intermediate-duration non-depolarizing neuromuscular blocking agent.
Each ml contains:
Atracurium Besylate U.S.P. ............................. 10 mg
Water for Injection U.S.P. .................................... q.s.
Excipient: Benzenesulphonic acid.
AtracadeTM is a sterile, non-pyrogenic, clear, colorless aqueous solution for intrave-nous administration containing Atracurium besylate. The pH of the aqueous solu-tion is adjusted with benzenesulphonic acid. Atracurium besylate is a non-depolarising, skeletal neuromuscular blocking agent having intermediate duration of action. The duration of neuromuscular blockade produced by AtracadeTM is approximately one-third to one-half the duration seen with d-tubocurarine, meto-curine and pancuronium at equipotent doses.
The pharmacokinetics of AtracadeTM in human beings is linear within the dose range of 0.3 to 0.6mg/kg. The elimination half-life is approximately 20 minutes. Duration of neuromuscular blockade produced by AtracadeTM does not correlate with plasma pseudo-cholinesterase levels and is not altered by the absence of renal function.
About 80% of Atracurium besylate is bound to plasma proteins. Atracurium besy-late and its metabolites cross the placenta in clinically insignificant quantities. Atracurium besylate is excreted in urine and bile mostly as metabolites. The me-tabolites have no neuromuscular blocking activity.
As an adjunct to general anesthesia or sedation in the intensive care unit, to facili-tate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
AtracadeTM is contraindicated in patients known to have hypersensitivity to Atracu-rium besylate or any of the other ingredients of AtracadeTM used in the prepara-tion.
Special precautions should be taken while administering AtracadeTM to those patients in whom substantial histamine release would be hazardous e.g. patients with cardiovascular disease and patients with any history suggesting a greater risk of histamine release. In these patients the recommended initial dose is lower (0.3 to 0.4mg/kg) and is required to be administered slowly or in divided doses over 1 minute. The mean arterial pressure decreases in a substantial percentage of pa-tients with a history of cardiovascular disease even at these doses.
The adverse effects of AtracadeTM are generally similar although they differ in their intensity to cause histamine release and cardiovascular effects. Histamine release may also lead to wheal-and-flare effects at the site of injection, flushing, occa-sionally broncho-spasm.
Reversal of neuromuscular blockade produced by AtracadeTM can be achieved with an anticholinesterase agents such as neostigmine, edrophonium or pyri-dostigmine in conjunction with an anticholinergic agent such as atropine or gly-copyrrolate. Complete reversal is usually accomplished within 8 to 10 minutes after the administration of reversal agents.
A number of drugs may influence and interfere with action of AtracadeTM, resulting in potentiation or antagonism of neuromuscular block. Inhalational anesthetics like halothane, isoflurane, enflurane potentiate the neuromuscular block produced by AtracadeTM. A depolarizing muscle relaxant such as suxamethonium chloride should not be administered to prolong the neuromuscular blocking effects of AtracadeTM (non-depolarising blocking agent), as this may result in a prolonged and complex block which can be difficult to reverse with anticholinesterase drugs. The magnitude and the duration of neuromuscular block produced by AtracadeTM may be increased as a result of interaction with Antibiotics such as aminoglyco-sides, polymyxins, tetracyclines and clindamycin.
Anti-arrhythmic drugs: Propranolol, Calcium channel blockers, lignocaine, pro-cainamide and quinidine;
Diuretics: frusemide, mannitol, thiazide diuretics, acetazolamide; Ganglion block-ing agents: hexamethonium, trimetaphan.
AtracadeTM should be used during pregnancy only if the potential benefit to the mother outweighs any potential risk to the foetus. AtracadeTM could be used for muscle relaxation during Caesarean section as it does not cross the placenta in clinically significant quantities.
As with other parenteral drug products, AtracadeTM should be inspected visually for particulate matter and discoloration prior to administration.
AtracadeTM should not be mixed or administered simultaneously with other drug solutions which are alkaline (Barbiturate Injections).
To avoid distress to the patient, AtracadeTM should not be administered before inducing unconsciousness.
AtracadeTM should be administered intravenously and must not be given intramus-cularly. Monitoring of neuromuscular function would help in minimizing the possibil-ity of over dosage and optimizing the dosage required. The recommended dos-ages are as follows:
Bolus injection for Intubation & Maintenance of Neuromuscular Blockade:
Adults - A dose of 0.4 to 0.5mg/kg
Maximum neuromuscular blockade is achieved within approximately 3 to 5 min-utes after injection. Clinically effective neuromuscular blockade generally lasts for 20 to 35 minutes under balanced anesthesia. Recovery to 25% of control is achieved approximately 35 to 45 minutes after injection and recovery is usually 95% complete 60 minutes after injection. AtracadeTM action is potentiated by isoflurane or enflurane anesthesia.
Doses of 0.08 to 0.1mg/kg are recommended for maintenance of neuromuscular blockade during prolonged surgical procedures. The first maintenance dose will generally be required 20 minutes after the initial administration of AtracadeTM. However, the need for maintenance dose should be judged by clinical criteria. As AtracadeTM is not accumulated in the body, maintenance dose may be adminis-tered at regular intervals ranging approximately from 15 to 25 minutes.
After administration of recommended initial bolus dose of AtracadeTM, a diluted solution can be administered by continuous infusion to adults and children aged 2 or more years for maintenance of neuromuscular blockade during extended surgical procedures. The rate of administration should be adjusted according to the patient’s response. A rate of 5 to 9μg/kg/min should be adequate to maintain
continuous neuromuscular blockade. An initial infusion rate of 9 to 10μg/kg/min. may be required to rapidly counteract the spontaneous recovery of neuromuscu-lar function.
Children - No dosage adjustments are required for pediatric patients 2 years of age or older. A dosage of 0.3 to 0.4mg/kg is recommended as the initial dose for infants (1 month to 2 years of age) under halothane anesthesia. Maintenance doses may be required with slightly greater frequency in children than in adults.
The recommended diluents for preparing infusion solutions of AtracadeTM are Dextrose Injection I.P., Sodium Chloride Injection I.P., 5% Dextrose and 0.9% Sodium Chloride Injection I.P. The infusion solutions may be used within 24 hours of prepara-tion, preferably the solution should be used as soon as it is prepared.
Any unused content from opened AtracadeTM ampoules should be discarded. No adjustments in the dosage of AtracadeTM are required for patients with renal dis-ease.
Special precautions are to be taken in adults or children having significant cardio-vascular disease during administration of AtracadeTM. An initial dose of 0.3 to 0.4mg/kg given slowly or in divided doses over 1 minute is recommended.
Store AtracadeTM at 20C - 80C. Do not freeze. Protect from light.
AtracadeTM is available in clear, colorless glass ampoules.
Each ampoule (2.5 ml) contains 25 mg of Atracurium besylate.
Sealed & Unopened containers, when stored as recommended have a shelf life of 24 months from date of manufacturing.
Keep out of reach of children.
Eghbal MH, Tabei H, Taregh SA, Razeghinejad MR.