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IMPORTANT SAFETY INFORMATION
Most frequent adverse events
In clinical trials, the most frequent adverse events with RAZADYNE
®
ER were similar to those seen with RAZADYNE
®
.
The most frequent adverse events that occurred with RAZADYNE ® were nausea, vomiting, diarrhea, anorexia, and weight loss.
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 pharmacological action, cholinesterase inhibitors have
vagotonic effects on the sinoatrial and atrioventricular (AV) nodes,
leading to bradycardia and AV block. These actions may be particularly
important to patients with supraventricular 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.
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. In clinical trials, there was no increase in
the incidence of convulsions with galantamine HBr compared with
placebo.
Pulmonary conditions
Cholinesterase inhibitors should be prescribed with care to patients
with a history of asthma or obstructive pulmonary disease.
Deaths in subjects with mild cognitive impairment (MCI)
In controlled trials in elderly subjects with MCI, 13 subjects on
RAZADYNE
®
(n=1026) and 1 subject on placebo (n=1022) died of various causes.
About half of the RAZADYNE
®
deaths appeared to result from various vascular causes (myocardial
infarction, stroke, and sudden death). RAZADYNE
®
and RAZADYNE
®
ER are not indicated for the treatment of MCI.
Hepatic or renal impairment
In patients with moderately impaired hepatic or renal function, dose
titration should proceed cautiously. The use of RAZADYNE
®
or RAZADYNE
®
ER in patients with severe hepatic impairment or severely impaired
renal function
(Cl
cr <9 mL/min) is not recommended.
Please see full Prescribing Information.
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This page was last updated on Nov 08 2010 at 03:27:53 EDT.