"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
General Dosing Guidance
Caregivers should be instructed about the recommended dosage and administration of RAZADYNE® ER and RAZADYNE® (galantamine hydrobromide). RAZADYNE® ER Extended-Release Capsules should be administered once daily in the morning, preferably with food. RAZADYNE® Tablets and Oral Solution should be administered twice per day, preferably with the morning and evening meals. Dose escalation (dose increases) should follow a minimum of four weeks at prior dose. If therapy has been interrupted for more than three days, the patient should be restarted with the lowest dose and then re-titrated to an appropriate dosage [see DOSAGE AND ADMINISTRATION].
Patients and caregivers should be advised to ensure adequate fluid intake during treatment [see DOSAGE AND ADMINISTRATION].
Patients and caregivers should be advised that the most frequent adverse events associated with use of the drug can be minimized by following the recommended dosage and administration.
Oral Solution Instruction Sheet
Caregivers should be instructed in the correct procedure for administering RAZADYNE® Oral Solution. In addition, they should be informed of the existence of an Instruction Sheet (included with the product) describing how the solution is to be administered. They should be urged to read this sheet prior to administering RAZADYNE® Oral Solution. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist.
Last reviewed on RxList: 8/6/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Razadyne ER Information
Razadyne ER - User Reviews
Razadyne ER User Reviews
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