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warnings
WARNINGS ATRACURIUM SHOULD BE USED ONLY BY THOSE SKILLED IN AIRWAY MANAGEMENT AND RESPIRATORY SUPPORT. EQUIPMENT AND PERSONNEL MUST BE IMMEDIATELY AVAILABLE FOR ENDOTRACHEAL INTUBATION AND SUPPORT OF VENTILATION, INCLUDING ADMINISTRATION OF POSITIVE PRESSURE OXYGEN. ADEQUACY OF RESPIRATION MUST BE ASSURED THROUGH ASSISTED OR CONTROLLED VENTILATION. ANTICHOLINESTERASE REVERSAL AGENTS SHOULD BE IMMEDIATELY AVAILABLE. DO NOT GIVE ATRACURIUM BESYLATE BY INTRAMUSCULAR ADMINISTRATION. Atracurium besylate has no known effect on consciousness, pain threshold, or cerebration. It should be used only with adequate anesthesia. Atracurium Besylate Injection, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions) in the same syringe or administered simultaneously during intravenous infusion through the same needle. Depending on the resultant pH of such mixtures, atracurium may be inactivated and a free acid may be precipitated. Atracurium Besylate Injection 10 mL multiple dose vials contain benzyl alcohol. Benzyl alcohol has been associated with an increased incidence of neurological and other complications in newborn infants which are sometimes fatal. Atracurium Besylate Injection 5 mL single dose vials do not contain benzyl alcohol.
ADVERSE REACTIONS Observed in Controlled Clinical Studies Atracurium was well tolerated and produced few adverse reactions during extensive clinical trials. Most adverse reactions were suggestive of histamine release. In studies including 875 patients, atracurium was discontinued in only one patient (who required treatment for bronchial secretions), and six other patients required treatment for adverse reactions attributable to atracurium (wheezing in one, hypotension in five). Of the five patients who required treatment for hypotension, three had a history of significant cardiovascular disease. The overall incidence rate for clinically important adverse reactions, therefore, was 7/875 or 0.8%. The table below includes all adverse reactions reported attributable to atracurium during clinical trials with 875 patients. PERCENT OF PATIENTS REPORTING ADVERSE REACTIONS Adverse Reaction Initial Atracurium Besylate Dose (mg/kg) 0.00-0.30 (n = 485) 0.31-0.50 Includes the recommended initial dosage range for most patients. (n = 366) 0.60 (n = 24) Total (n = 875) Skin Flush 1.0% 8.7% 29.2% 5.0% Erythema 0.6% 0.5% 0% 0.6% Itching 0.4% 0% 0% 0.2% Wheezing/Bronchial Secretions 0.2% 0.3% 0% 0.2% Hives 0.2% 0% 0% 0.1% Most adverse reactions were of little clinical significance unless they were associated with significant hemodynamic changes. The table below summarizes the incidences of substantial vital sign changes noted during atracurium clinical trials with 530 patients, without cardiovascular disease, in whom these parameters were assessed. PERCENT OF PATIENTS SHOWING 30% VITAL SIGN CHANGES FOLLOWING ADMINISTRATION OF ATRACURIUM Vital Sign Change Initial Atracurium Besylate Dose (mg/kg) 0.00-0.30 (n = 365) 0.31-0.50 Includes the recommended initial dosage range for most patients. (n = 144) 0.60 (n = 21) Total (n = 530) Mean Arterial Pressure Increase 1.9% 2.8% 0% 2.1% Decrease 1.1% 2.1% 14.3% 1.9% Heart Rate Increase 1.6% 2.8% 4.8% 2.1% Decrease 0.8% 0% 0% 0.6% Observed in Clinical Practice Based on initial clinical practice experience in approximately 3 million patients who received atracurium in the U.S. and in the United Kingdom, spontaneously reported adverse reactions were uncommon (approximately 0.01-0.02%). The following adverse reactions are among the most frequently reported, but there are insufficient data to support an estimate of their incidence: General Allergic reactions (anaphylactic or anaphylactoid responses) which, in rare instances, were severe (e.g., cardiac arrest) Musculoskeletal Inadequate block, prolonged block Cardiovascular Hypotension, vasodilatation (flushing), tachycardia, bradycardia Respiratory Dyspnea, bronchospasm, laryngospasm Integumentary Rash, urticaria, reaction at injection site There have been rare spontaneous reports of seizures in ICU patients following long-term infusion of atracurium to support mechanical ventilation. There are insufficient data to define the contribution, if any, of atracurium and/or its metabolite laudanosine. (See PRECAUTIONS, Long-Term Use in Intensive Care Unit [ICU] ).