nence 1 2
Vascular disorders
Hypertension 2 4
Hypotension 1 2
6.4 Vital Sign Changes NAMENDA XR and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure, diastolic blood pressure, and weight) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. There were no clinically important changes in vital signs in patients treated with NAMENDA XR. A comparison of supine and standing vital sign measures for NAMENDA XR and placebo in Alzheimer's patients indicated that NAMENDA XR treatment is not associated with orthostatic changes.
6.5 Laboratory Changes NAMENDA XR and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in laboratory test parameters associated with NAMENDA XR treatment.
6.6 ECG Changes NAMENDA XR and placebo groups were compared with respect to (1) mean change from baseline in various ECG parameters and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in ECG parameters associated with NAMENDA XR treatment.
6.7 Other Adverse Reactions Observed During Clinical Trials of NAMENDA XR Following is a list of treatment-emergent adverse reactions reported from 750 patients treated with NAMENDA XR for periods up to 52 weeks in double-blind or open-label clinical trials. The listing does not include those events already listed in Table 1, those events for which a drug cause was remote, those events for which descriptive terms were so lacking in specificity as to be uninformative, and those events reported only once which did not have a substantial probability of being immediately life threatening. Events are categorized by body system.
Blood and Lymphatic System Disorders: anemia.
Cardiac Disorders: bradycardia, myocardial infarction.
Gastrointestinal Disorders: fecal incontinence, nausea.
General Disorders: asthenia, fatigue, gait disturbance, irritability, peripheral edema, pyrexia.
Infections and Infestations: bronchitis, nasopharyngitis, pneumonia, upper respiratory tract infection, urinary tract infection.
Injury, Poisoning and Procedural Complications: fall.
Investigations: weight decreased.
Metabolism and Nutrition Disorders: anorexia, dehydration, decreased appetite, hyperglycemia.
Musculoskeletal and Connective Tissue Disorders: arthralgia, pain in extremity.
Nervous System Disorders: convulsion, dementia Alzheimer's type, syncope, tremor.
Psychiatric Disorders: agitation, confusional state, delirium, delusion, disorientation, hallucination, insomnia, restlessness.
Respiratory, Thoracic and Mediastinal Disorders: cough, dyspnea.
6.8 Memantine Immediate Release Clinical Trial and Post Marketing Spontaneous Reports The following additional adverse reactions have been identified from previous worldwide experience with memantine (immediate release) use. These adverse reactions have been chosen fo |
