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 hydrobromide, 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 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 hydrobromide 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
hydrobromide 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 (Clcr < 9 mL/min) is not recommended.
