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Enlon Plus (Edrophonium Chloride / Atropine Sulfate) - Side Effects and Adverse Reactions

 
 



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.

Drug label data at the top of this Page last updated: 2013-01-31

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