Galantamine Hydrobromide Recall
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FDA Labeling Changes
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Galantamine Hydrobromide Tablets, USP are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type.
There is currently no drug history available for this drug.
Galantamine hydrobromide tablets, USP is a reversible, competitive acetylcholinesterase inhibitor. It is known chemically as
(4aS,6R,8aS)-4a,5,9,10,11,12-hexahydro-3-methoxy-11-methyl-6H-benzofuro[3a,3,2-ef]benzazepin-6-ol hydrobromide. It has an empirical formula of C17H21NO3 •HBr and a molecular weight of 368.27. Galantamine hydrobromide is a white to almost white powder and is sparingly soluble in water. The structural formula for galantamine hydrobromide is:
Galantamine hydrobromide tablets contain 4 mg, 8 mg, and 12 mg galantamine as 5.126, 10.253 and 15.379 mg of galantamine hydrobromide, respectively. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, pregelatinized starch, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and titanium dioxide. The 4 mg tablets contain PEG 400 and polysorbate 80. The 8 mg tablets contain D&C red #27, triacetin and FD&C blue #1. The 12 mg tablets contain triethyl citrate, FD&C yellow # 6 and iron oxide yellow.
Galantamine Hydrobromide Manufacturers
Yabao Pharmaceutical Co., Ltd. Beijing
Watson Laboratories, Inc.
Global Pharmaceuticals, Division Of Impax Laboratories Inc.
Barr Laboratories Inc.
Sun Pharma Global Fze
Mylan Pharmaceuticals Inc.
Patriot Pharmaceuticals, Llc
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