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RAZADYNE® ER Dosing
Convenient once-daily dosing and titration when you prescribe RAZADYNE® ER
- Start with the 8 mg QD initial dosage for 4 weeks
- Step up to the 16 mg QD initial maintenance dosage*
Additional titration to 24 mg/day is based on clinical judgment (benefit and tolerability) and should be attempted after a minimum of 4 weeks at 16 mg/day.
*Wait at least 4 weeks prior to increasing to this dosage.
RAZADYNE®ER should be administered once daily in the morning, preferably with food.
There is no evidence that galantamine alters the course of the underlying dementing process.
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 activity may also be a manifestation of Alzheimer's disease.
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.
Most common Adverse Events
The most common adverse events occuring at rate of at least 5%
and at least twice that of placebo at the recommended maintenance
dose of either 16 or 24 mg/day under conditions of every 4 week dose
escalation for each 8-mg increase were nausea, vomiting, diarrhea, anorexia, and weight decrease.
Please see full Prescribing Information.
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This page was last updated on May 14 2012 at 12:43:36 EDT.