ontains 14 mg memantine HCl.
Each 21 mg capsule contains 21 mg memantine HCl.
Each 28 mg capsule contains 28 mg memantine HCl.
For a full list of excipients, see Description (11).
4 CONTRAINDICATIONS
4.1 Hypersensitivity NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation [See Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Genitourinary Conditions Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine.
5.2 Seizures NAMENDA XR has not been systematically eva luated in patients with a seizure disorder. In clinical trials of memantine, seizures occurred in 0.3% of patients treated with memantine and 0.6% of patients treated with placebo.
6 ADVERSE REACTIONS
6.1 Clinical Trial Data Sources NAMENDA XR was eva luated in a double-blind placebo-controlled trial treating a total of 676 patients with moderate to severe dementia of the Alzheimer's type (341 patients treated with NAMENDA XR 28 mg/day dose and 335 patients treated with placebo) for a treatment period up to 24 weeks.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
6.2 Adverse Reactions Leading to Discontinuation In the placebo-controlled clinical trial of NAMENDA XR [See Clinical Studies (14)], which treated a total of 676 patients, the proportion of patients in the NAMENDA XR 28 mg/day dose and placebo groups who discontinued treatment due to adverse events were 10.0% and 6.3%, respectively. The most common adverse reaction in the NAMENDA XR treated group that led to treatment discontinuation in this study was dizziness at a rate of 1.5%.
6.3 Most Common Adverse Reactions The most commonly observed adverse reactions seen in patients administered NAMENDA XR in the controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a higher frequency than placebo were headache, diarrhea and dizziness.
Table 1 lists treatment-emergent adverse reactions that were observed at an incidence of ≥ 2% in the NAMENDA XR treated group and occurred at a rate greater than placebo.
Table 1: Adverse reactions observed with a frequency of ≥ 2% and occurring with a rate greater than placebo Adverse reaction Placebo
(n = 335)
% NAMENDA XR 28mg
(n = 341)
%
Gastrointestinal Disorders
Diarrhea 4 5
Constipation 1 3
Abdominal pain 1 2
Vomiting 1 2
Infections and infestations
Influenza 3 4
Investigations
Weight, increased 1 3
Musculoskeletal and connective tissue disorders
Back pain 1 3
Nervous system disorders
Headache 5 6
Dizziness 1 5
Somnolence 1 3
Psychiatric disorders
Anxiety 3 4
Depression 1 3
Aggression 1 2
Renal and urinary disorders
Urinary inconti |
