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Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ENLON-PLUS (edrophonium chloride, USP and atropine sulfate, USP) Injection is recommended as a reversal agent or antagonist of nondepolarizing neuromuscular blocking agents. It is not effective against depolarizing neuromuscular blocking agents. It is also useful if used adjunctively in the treatment of respiratory depression caused by curare overdosage.
The appropriateness of the specific fixed ratio of edrophonium and atropine contained in ENLON-PLUS has not been evaluated in myasthenia gravis. Therefore, ENLON-PLUS is not recommended for use in the differential diagnosis of this condition.
History
There is currently no drug history available for this drug.
Other Information
ENLON-PLUS (edrophonium chloride, USP and atropine sulfate, USP) Injection, for intravenous use, is a sterile, nonpyrogenic, nondepolarizing neuromuscular relaxant antagonist. ENLON-PLUS is a combination drug containing a rapid acting acetylcholinesterase inhibitor, edrophonium chloride, and an anticholinergic, atropine sulfate. Chemically, edrophonium chloride is ethyl (m-hydroxyphenyl) dimethylammonium chloride; its structural formula is:
Molecular Formula: C10H16ClNO
Molecular Weight: 201.70
Chemically, atropine sulfate is: endo-(±)-alpha-(hydroxymethyl)-8-methyl-8-azabicyclo [3.2.1]oct-3-yl benzeneacetate sulfate (2:1) monohydrate. Its structural formula is:
Molecular Formula: (C17H23NO3)2•H2SO4•H2O
Molecular Weight: 694.84
ENLON-PLUS contains in each mL of sterile solution:
5 mL Ampule: 10 mg edrophonium chloride and 0.14 mg atropine sulfate compounded with 2.0 mg sodium sulfite as a preservative and buffered with sodium citrate and citric acid. The pH range is 4.0-5.0.
Sources
Enlon Plus Manufacturers
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Mylan Institutional Llc
Enlon Plus | Mylan Institutional Llc
Dosages of ENLON-PLUS (edrophonium chloride, USP and atropine sulfate, USP) Injection range from 0.05-0.1 mL/kg given slowly over 45 seconds to 1 minute at a point of at least 5% recovery of twitch response to neuromuscular stimulation (95% block). The dosage delivered is 0.5-1.0 mg/kg of edrophonium chloride and 0.007-0.014 mg/kg of atropine sulfate. A total dosage of 1.0 mg/kg of edrophonium chloride should rarely be exceeded. Response should be monitored carefully and assisted or controlled ventilation secured. Satisfactory reversal permits adequate voluntary respiration and neuromuscular transmission (as tested with a peripheral nerve stimulator). Recurarization has not been reported after satisfactory reversal has been attained.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
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