20 Q & A
Pharmacy Practice News • July 2009
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Enlon® (edrophonium chloride injection, USP) and Enlon-Plus® (edrophonium chloride, USP and atropine sulfate, USP) Injection
A
fter Baxter announced in February 2008 the discontinuation of Enlon® (edrophonium chloride injection, USP) and Enlon-Plus® (edrophonium chloride, USP and atropine sulfate, USP) Injection, Bioniche Pharma, a leading developer and manufacturer of injectable pharmaceuticals, initiated the process to acquire these important products and bring them back to market and into the hands of health care professionals. On May 15, 2009, Bioniche Pharma announced the launch of Enlon and EnlonPlus Injection.
Q. What are the indications for Enlon®?
dimethyl-tubocurarine. It is not effective against decamethonium bromide and succinylcholine chloride. It may be used adjunctively in the treatment of respiratory depression caused by curare overdosage.
A. Enlon is recommended for the differential diagnosis of myasthenia gravis and as an adjunct in the evaluation of treatment requirements in this disease. It may also be used for evaluating emergency treatment in myasthenic crises. Because of its brief duration of action, it is not recommended for maintenance therapy in myasthenia gravis. Enlon is also useful whenever a curare antagonist is needed to reverse the neuromuscular block produced by curare, tubocurarine, gallamine triethiodide or
Q. Who should not use Enlon? A. The stopper for Enlon contains latex. Anyone with known hypersensitivity to anticholinesterase agents; intestinal and urinary obstructions of mechanical type should not use Enlon. Enlon should be used with caution in patients with bronchial asthma or cardiac dysrhythmias. Enlon
contains sodium sulfite, which may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The myasthenic patient in crisis who is being tested with Enlon should be observed for bradycardia or cardiac standstill and cholinergic reactions if an overdose is given. The safety of Enlon during pregnancy or lactation in humans has not been established. Therefore, use of Enlon in women who may become pregnant requires weighing the drug’s potential benefits against its possible hazards to mother and child. Care should be given when administering this drug to patients with symptoms of myasthenic weakness who are also on anticholinesterase drugs. Q. What are the indications and usage for Enlon-Plus?
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Enlon
®
(edrophonium chloride injection, USP)
Enlon-Plus
®
(edrophonium chloride, USP & atropine sulfate, USP) Injection
®
NDC Number
Description
AmerisourceBergen
Cardinal
McKesson
67457-190 -15
10 mg/mL, 15 mL Vial
368878
4119566
1853506
67457-191-15
10 mg/mL edrophonium Cl, 0.14 mg/mL atropine sulfate 15 mL Vial
67457-192- 05
10 mg/mL edrophonium Cl, 0.14 mg/mL atropine sulfate 5 mL Ampul
Enlon-Plus
367797
4119582
1878313
®
A. The stopper for Enlon-Plus contains latex. The appropriateness of the specific fixed ratio of edrophonium and atropine contained in Enlon-Plus has not been evaluated in myasthenia gravis. Therefore, it is not recommended for use in the differential diagnosis of this condition. EnlonPlus is not to be used in patients with known hypersensitivity to either of the components, or in patients with intestinal or urinary obstruction of mechanical type. Atropine sulfate is contraindicated in the presence of acute glaucoma, adhesions (synechiae) between the iris and lens of the eye and pyloric stenosis. Enlon-Plus 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. Enlon-Plus contains sodium sulfite, which may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. There is a potential for tissue irritation by extravascular injection. Enlon-Plus should be administered with caution to patients with symptoms of myasthenic weakness who are also on anticholinesterase drugs. It is not known whether Enlon-Plus can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Enlon-Plus should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety of Enlon-Plus during lactation in humans has not been established. Safety and effectiveness in pediatric patients have not been established. There were insufficient numbers of subjects aged 65 or over in the clinical studies of Enlon-Plus to determine whether they respond differently from younger subjects.
A. Bioniche supplies Enlon in 10 mg/mL, 15 mL vials and Enlon-Plus in 15 mL vials and 5 mL ampuls. Q. How do I order Enlon and Enlon-Plus?
A. To order Bioniche Pharma products, contact your wholesaler or distributor, or call Customer Service at (888) 258-4199. Please see full prescribing information for more information.
367342
4119590
1860527
C U S T O M E R S E R V I C E 8 8 8 - 2 5 8 - 4 19 9 • B I O N I C H E P H A R M A . C O M © 2009, Bioniche Pharma USA LLC.
Q. Who shouldn’t use Enlon-Plus?
Q. How does Bioniche supply Enlon and Enlon-Plus?
PL A C E A N OR DE R TODAY. Enlon
A. Enlon-Plus 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.