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New Long-Term Study Suggests Lower Mortality in Alzheimer's Patients Treated with Galantamine Versus Placebo
Date:12/5/2012

s sold as RAZADYNE® and RAZADYNE® ER by Janssen Pharmaceuticals, Inc.

Important Safety Information

In clinical trials, once-daily treatment with RAZADYNE® ER was well tolerated and the adverse events were similar to those seen with twice daily RAZADYNE® tablets.

Anesthesia

Cholinesterase inhibitors, such as galantamine HBr, are likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.

Cardiovascular events

Because of their pharmacologic action, cholinesterase inhibitors have vagotonic effects on the sinoatrial (SA) and atrioventrical (AV) nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with superventricular cardiac conduction disorders, or to patients taking other drugs concomitantly that significantly slow heart rate. In clinical trials, galantamine HBr was associated with more frequent reports of bradycardia and syncope vs placebo. Post marketed surveillance of marketed anticholinesterase inhibitors has shown that bradycardia and all types of heart block have been reported in patients both with and without known underlying cardiac conduction abnormalities. All patients should be considered at risk for adverse effects on cardiac conduction.

Gastrointestinal

Cholinesterase inhibitors may increase gastric acid secretion. Patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk of developing ulcers, eg, those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs.

Genitourinary

Cholinesterase inhibitors may cause bladder outflow obstruction.

Neurological conditions

Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure
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SOURCE Janssen Research & Development, LLC
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