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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 (edrophonium chloride and atropine sulfate) . 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 (edrophonium chloride and atropine sulfate) is used.
ENLON-PLUS (edrophonium chloride and atropine sulfate) 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.
As with any antagonist of nondepolarizing muscle relaxants, adequate recovery of voluntary respiration and neuromuscular transmission must be obtained prior to the discontinuation of respiratory assistance. Should a patient develop “anticholinesterase insensitivity” for brief or prolonged periods, the patient should be carefully monitored and the dosage of anticholinesterase drugs reduced or withheld until the patient again becomes sensitive to them. Use with caution in patients with prostatic hypertrophy and in debilitated patients with chronic lung disease.
When used in therapeutic doses, atropine can cause dryness of the mouth. This effect is additive when the product is administered with other drugs that can cause dryness of the mouth.
Since atropine sulfate slows gastric emptying and gastrointestinal motility, it may interfere with the absorption of other medications. The effect of atropine on dryness of the mouth may be increased if it is given with other drugs that have anticholinergic action (tricyclic antidepressants, antipsychotics, some antihistamines, and antiparkinsonism drugs).
Pregnancy Category C
Animal reproduction studies have not been conducted with ENLON-PLUS (edrophonium chloride and atropine sulfate) . It is also not known whether ENLON-PLUS (edrophonium chloride and atropine sulfate) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ENLON-PLUS (edrophonium chloride and atropine sulfate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and Delivery
The effect of ENLON-PLUS (edrophonium chloride and atropine sulfate) on the mother and fetus, on the duration of labor or delivery, in the possibility that a forceps delivery or other intervention or resuscitation of the newborn will be necessary, is not known. The effect of the combination drug on the later growth, development and functional maturation of the child is also unknown.
The safety of ENLON-PLUS (edrophonium chloride and atropine sulfate) during lactation in humans has not been established.
Safety and effectiveness in pediatric patients have not been established. Pediatric patients may have increased vagal tone. The effect of fixed ratios of edrophonium and atropine on heart rate in such patients has not been evaluated.
Clinical studies of ENLON-PLUS (edrophonium chloride and atropine sulfate) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/4/2009
Additional Enlon Plus Information
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