Memantine

Treatment of patients with moderate to severe Alzheimer's disease.

Treatment of adult patients with moderate to severe Alzheimer’s disease.

1 INDICATIONS AND USAGE Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride tablets are an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

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Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.

WARNINGS NEUROLOGICAL CONDITIONS Seizures:

Memantine hydrochloride has not been systematically evaluated in patients with a seizure disorder. These patients were excluded from clinical studies during the premarketing testing of memantine hydrochloride. 4% of patients treated with placebo.

Seizure activity may be a manifestation of Alzheimer’s disease. The risk/benefit of memantine treatment for patients with a history of seizure disorder or predisposing factors for epilepsy must, therefore, be carefully evaluated. GENITOURINARY CONDITIONS Conditions that raise urine pH may reduce the urinary elimination of memantine by a factor of 7 to 9, resulting in increased plasma levels of memantine (see ACTIONS AND CLINICAL PHARMACOLOGY).