"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
Clinical Trials Experience
NAMENDA XR was evaluated in a double-blind placebo-controlled trial in which a total of 676 patients with moderate to severe dementia of the Alzheimer's type (341 patients on NAMENDA XR 28 mg/day and 335 patients on placebo) were treated for 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.
Adverse Reactions Leading to Discontinuation
In the placebo-controlled clinical trial of NAMENDA XR, the proportion of patients in the NAMENDA XR group and the placebo group who discontinued treatment due to adverse reactions was 10% and 6%, respectively. The most common adverse reaction that led to treatment discontinuation in the NAMENDA XR group was dizziness, at a rate of 1.5%.
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 frequency higher than placebo, were headache, diarrhea and dizziness.
Table 1 lists adverse reactions that were observed at an incidence of ≥ 2% in the NAMENDA XR group and occurred at a rate greater than placebo.
Table 1: Adverse reactions observed with a frequency
of ≥ 2% in the NAMENDA XR group and at a rate greater than placebo
(n = 335) %
|NAMENDA XR 28mg
(n = 341) %
|Infections and infestations|
|Musculoskeletal and connective tissue disorders|
|Nervous system disorders|
|Renal and urinary disorders|
Memantine has not been systematically evaluated 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.
The following adverse reactions have been identified during post-approval use of memantine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include:
Cardiac Disorders: cardiac failure congestive.
Gastrointestinal disorders: pancreatitis.
Hepatobiliary Disorders: hepatitis.
Psychiatric Disorders: suicidal ideation.
Renal and Urinary Disorders: acute renal failure (including increased creatinine and renal insufficiency).
Skin Disorders: Stevens Johnson syndrome.
Read the Namenda XR (memantine hydrochloride extended release capsules) Side Effects Center for a complete guide to possible side effects
Drugs That Make The Urine Alkaline
The clearance of memantine was reduced by about 80% under alkaline urine conditions at pH 8. Therefore, alterations of urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse effects. Urine pH is altered by diet, drugs (e.g. carbonic anhydrase inhibitors, sodium bicarbonate) and clinical state of the patient (e.g. renal tubular acidosis or severe infections of the urinary tract). Hence, memantine should be used with caution under these conditions.
Use With Other N-methyl-D-aspartate (NMDA) Antagonists
The combined use of NAMENDA XR with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution.
Last reviewed on RxList: 10/14/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Namenda XR Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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