Galantamine package insert

GALANTAMINE PACKAGE INSERT

galantamine is

Galantamine HydrobromideGalantamine Hydrobromide (Reminyl®, Janssen Pharmaceuticals)Alzheimer’s disease (AD) is estimated to affect approximately 4 million people in the United States and the number of patients with AD is expected to reach 14 million within the next 50 years. Alzheimer’s disease is the most common type of dementia, characterized by a progressive loss of cognitive abilities, behavioral disturbances, and a discernable neuropathology. It is the third most expensive illness in the United Stated, second only to heart disease and cancer. Although the etiology of AD is not fully understood, it is generally accepted that the progressive loss of cognitive function most likely originates from losses of basal forebrain cortical neurons and reduced acetylcholine synthesis in the brain. The extent of loss of central cholinergic function has been correlated with the degree of cognitive impairment experienced by patients as well as with the formation of Wilcock et al. conducted a study to evaluate the safety and effectiveness of galantamine at two different maintenance doses for the treatment of mild to moderate Alzheimer’s disease (AD). The study, titled the Galantamine International-1 Study Group, was a randomized, double blind, parallel group, placebo controlled trial conducted in eight countries outside of the U.S. It utilized an intention to treat protocol in which all patients that received galantamine were included in the analysis of baseline characteristics and safety data. Disease progression in all patients was monitored by use of ADAS-cog/11 and CIBIC-plus. Of the 653 patients enrolled in the study, 215 were randomized to the placebo group, 220 to the 24 mg galantamine group and 218 to the 36 mg galantamine group. In both galantamine groups, the dose was initiated at 8 mg per day for one week, then increased to the target dose by 8 mg per day at weekly intervals.