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.
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