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warnings
WARNINGS ENLON-PLUS (edrophonium chloride, USP and atropine sulfate, USP) Injection should be used with caution in patients with bronchial asthma or cardiac arrhythmias. Cardiac arrest has been reported to occur in digitalized patients as well as in jaundiced subjects receiving cholinesterase inhibitors. In patients with cardiovascular disease, given anesthesia with narcotic and nitrous oxide without a potent inhalational agent, there is increased risk for clinically significant bradycardia. In patients receiving beta-adrenergic blocking agents there is increased risk for excessive bradycardia from unopposed parasympathetic vagal tone. Such patients should receive atropine sulfate alone prior to ENLON-PLUS. Isolated instances of respiratory arrest have also been reported following the administration of edrophonium chloride. Additional atropine sulfate (1 mg) should be available for immediate use to counteract severe cholinergic reaction which may occur in hypersensitive individuals when ENLON-PLUS is used. ENLON-PLUS 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. There is a potential for tissue irritation by extravascular injection.
ADVERSE REACTIONS Cardiovascular: Arrhythmias Frequency >10%: junctional rhythm, bradycardia, tachycardia; Frequency 3-10%: first and second degree A-V block, P Wave changes, atrial premature contractions; Frequency 1-3%: third degree A-V block, ventricular premature contractions; Frequency less than 1%: 3 second R-R interval. Of the patients who experienced any arrhythmias, 85% had the onset within two minutes, 74% no longer had any arrhythmias after 10 minutes. Arrhythmias related to increased vagal tone, bradycardia, second and third degree heart block respond to treatment with 0.2-0.4 mg of atropine I.V. (Bigeminy or ventricular ectopy may be treated with lidocaine 50 mg I.V.). Adverse experiences reported for anticholinesterase agents such as edrophonium chloride, but not observed in the 235 patients studied with ENLON-PLUS (edrophonium chloride, USP and atropine sulfate, USP) Injection: Cardiovascular: Nonspecific EKG changes, fall in cardiac output leading to hypotension; Respiratory: Increased tracheobronchial secretions, laryngospasm, bronchiolar constriction and respiratory muscle paralysis; Neurologic: Convulsions, dysarthria, dysphonia, and dysphagia; Gastrointestinal: Nausea, vomiting, increased peristalsis, increased gastric and intestinal secretions, diarrhea, abdominal cramps; Musculoskeletal: Weakness and fasciculations; Miscellaneous: Increased urinary frequency, diaphoresis, increased lacrimation, pupillary constriction, diplopia, and conjunctival hyperemia. Untoward reactions to atropine sulfate generally are dose-related. Individual tolerance varies greatly but systemic doses of 0.5 to 10 mg are likely to produce the following effects, which were not observed in the 235 patients treated with ENLON-PLUS: NEUROLOGIC: Speech disturbances and restlessness with asthenia; DERMATOLOGIC: Flushed, dry skin, formation of a scarlatiniform rash; MISCELLANEOUS: Dryness of the nose and mouth, thirst, blurred vision, photophobia, slight mydriasis. Atropine may produce fever through inhibition of heat loss by evaporation.