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RAZADYNE® ER Information
When they know something is wrong...
RAZADYNE® ER is an effective, once-daily option
RAZADYNE® ER is an acetylcholinesterase inhibitor (AChEI). RAZADYNE® ER is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.
In a 6-month clinical trial comparing RAZADYNE® ER to placebo, patients treated with RAZADYNE® ER showed significant improvement in cognitive performance vs placebo as measured by the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog/11). Patients treated with RAZADYNE® ER significantly improved in activities of daily living (ADLs)* vs placebo as measured by the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale. This was a secondary efficacy measure in this study.
RAZADYNE® ER may help patients by:
- Maintaining cognitive and functional abilities
- Offering convenient, once-daily dosing
*"Activities of daily living" include eating, walking, using the restroom, bathing, grooming, dressing, physical performance, using common household appliances, conversation, tending to the home, managing personal belongings, travel, shopping, knowledge of current events, reading, and writing.9
Click the link to learn more about how RAZADYNE® ER can help your patients with Alzheimer's mild to moderate dementia of the Alzheimer's type.
- Samochocki M, Zerlin M, Jostock R, et al. Galantamine is an allosterically potentiating ligand of the human α4/β2 nAChR. Acta Neurol Scand. 2000;176(suppl):68-73.
- Maelicke A, Albuquerque EX. Allosteric modulation of nicotinic acetylcholine receptors as a treatment strategy for Alzheimer's disease. Eur J Pharmacol. 2000;393:165-170.
- Galasko D, Bennett D, Sano M et al, An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord 1997;11(Suppl 2):S33-9.
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 12:43:32 EDT.