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FDA Labeling Changes
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Memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
There is currently no drug history available for this drug.
Memantine hydrochloride is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:
The molecular formula is C12H21N•HCl and the molecular weight is 215.76.
Memantine HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride is available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose, talc, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and anhydrous lactose. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, macrogol/polyethylene glycol 4000, FD&C yellow #6, iron oxide red and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 4000 and FD&C blue #2 (10 mg tablets).