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warnings
WARNINGS Whenever anticholinesterase drugs are used for testing, a syringe containing 1 mg of atropine sulfate should be immediately available to be given in aliquots intravenously to counteract severe cholinergic reactions which may occur in the hypersensitive individual, whether he is normal or myasthenic. ENLON should be used with caution in patients with bronchial asthma or cardiac dysrhythmias. The transient bradycardia which sometimes occurs can be relieved by atropine sulfate. Isolated instances of cardiac and respiratory arrest following administration of ENLON have been reported. It is postulated that these are vagotonic effects. Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Usage in Pregnancy The safety of ENLON during pregnancy or lactation in humans has not been established. Therefore, use of ENLON in women who may become pregnant requires weighing the drug’s potential benefits against its possible hazards to mother and child.
ADVERSE REACTIONS Careful observation should be made for severe cholinergic reactions in the hyperreactive individual. The myasthenic patient in crisis who is being tested with ENLON should be observed for bradycardia or cardiac standstill and cholinergic reactions if an overdose is given. The following reactions common to anticholinesterase agents may occur, although not all of these reactions have been reported with the administration of ENLON, probably because of its short duration of action and limited indications: Eye: Increased lacrimation, pupillary constriction, spasm of accommodation, diplopia, conjunctival hyperemia. CNS: Convulsions, dysarthria, dysphonia, dysphagia. Respiratory: Increased tracheobronchial secretions, laryngospasm, bronchiolar constriction, paralysis of muscles of respiration, central respiratory paralysis. Cardiac: Arrhythmias (especially bradycardia), fall in cardiac output leading to hypotension. G.I.: Increased salivary, gastric and intestinal secretion, nausea, vomiting, increased peristalsis, diarrhea, abdominal cramps. Skeletal Muscle: Weakness, fasciculations. Miscellaneous: Increased urinary frequency and incontinence, diaphoresis.