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NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on:
- memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and donepezil hydrochloride 10 mg.
- memantine hydrochloride (5 mg twice daily or 14 mg extended-release once daily) and donepezil hydrochloride 10 mg (in patients with severe renal impairment).
There is currently no drug history available for this drug.
NAMZARIC capsules contain memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt.
The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula:
The molecular formula is C12H21N•hydrochloride and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder.
The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride.
The molecular formula is C24H29NO3•hydrochloride and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder.
NAMZARIC is provided as capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg).
All doses of NAMZARIC contain the following inactive ingredients: sugar spheres, povidone, talc, hypromellose, polyethylene glycol, ethylcellulose, oleic acid, medium chain triglycerides, lactose monohydrate, microcrystalline cellulose, corn starch, colloidal silicon dioxide, and magnesium stearate. The hard gelatin capsules contain titanium dioxide, gelatin, shellac glaze, and black iron oxide; colorants are FD&C Blue 1 (28mg/10mg) and FD&C Blue 1 and yellow iron oxide (14 mg/10 mg).