NAMENDA (Memantine Hydrochloride) Tablet [PD-Rx Pharmaceuticals, Corporation.]

The knowledge described within this section stems from studies in patients with Alzheimer’s and vascular dementia.

Adverse Occasions Resulting in Stopping: In placebo-controlled trials by which dementia patients received doses of Namenda as much as 20 mg/day, the probability of stopping due to a bad event was exactly the same within the Namenda group as with the placebo group. No individual adverse event was connected using the stopping of treatment in 1% or even more of Namenda-treated patients and for a price more than placebo.

Adverse Occasions Reported in Controlled Trials: The reported adverse occasions in Namenda (memantine hydrochloride) trials reflect experience acquired under carefully monitored conditions inside a highly selected patient population. In actual practice or perhaps in other numerous studies, these frequency estimates might not apply, because the conditions useful, reporting behavior and the kinds of patients treated may vary. Table 1 lists treatment-emergent signs and signs and symptoms which were reported in a minimum of 2% of patients in placebo-controlled dementia trials as well as for that the rate of occurrence was greater for patients given Namenda compared to individuals given placebo. No adverse event happened in a frequency with a minimum of 5% and two times the placebo rate.

Other adverse occasions occurring by having an incidence with a minimum of 2% in Namenda-treated patients but in a greater or equal rate on placebo were agitation, fall, inflicted injuries, bladder control problems, diarrhea, bronchitis, insomnia, urinary system infection, influenza-like signs and symptoms, abnormal gait, depression, upper respiratory system infection, anxiety, peripheral edema, nausea, anorexia, and arthralgia.

The general profile of adverse occasions and also the incidence rates for individual adverse occasions within the subpopulation of patients with moderate to severe Alzheimer’s weren’t not the same as the profile and incidence rates described above for that overall dementia population.

Vital Sign Changes: Namenda and placebo groups were compared regarding (1) mean vary from baseline in vital signs (pulse, systolic bloodstream pressure, diastolic bloodstream pressure, and weight) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline during these variables. There have been no clinically important alterations in vital signs in patients given Namenda. An evaluation of supine and standing vital sign measures for Namenda and placebo in seniors normal subjects established that Namenda treatment methods are not connected with orthostatic changes.

Laboratory Changes: Namenda and placebo groups were compared regarding (1) mean vary from baseline in a variety of serum chemistry, hematology, and urinalysis variables and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline during these variables. These analyses revealed no clinically important alterations in laboratory test parameters connected with Namenda treatment.

ECG Changes: Namenda and placebo groups were compared regarding (1) mean vary from baseline in a variety of ECG parameters and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline during these variables. These analyses revealed no clinically important alterations in ECG parameters connected with Namenda treatment.

Other Adverse Occasions Observed During Numerous Studies

Namenda continues to be administered to roughly 1350 patients with dementia, who greater than 1200 received the utmost suggested dose of 20 mg/day. Patients received Namenda strategy to periods as high as 884 days, with 862 patients receiving a minimum of 24 days of treatment and 387 patients receiving 48 days or even more of treatment.

Treatment emergent signs and signs and symptoms that happened during 8 controlled numerous studies and 4 open-label trials were recorded as adverse occasions through the clinical investigators using terminology that belongs to them selecting. To supply a general estimate from the proportion of people getting similar kinds of occasions, the occasions were grouped right into a smaller sized quantity of standardized groups using WHO terminology, and event frequencies were calculated across all studies.

All adverse occasions occurring in a minimum of two people are incorporated, aside from individuals already indexed by Table 1, WHO terms too general to become informative, minor signs and symptoms or occasions unlikely to become drug-caused, e.g., since they’re common within the study population. Occasions are sorted by body and listed while using following definitions: frequent adverse occasions – individuals occurring in a minimum of 1/100 patients infrequent adverse occasions – individuals occurring in 1/100 to at least oneOr1000 patients. These adverse occasions aren’t always associated with Namenda treatment and often were observed in a similar frequency in placebo-treated patients within the controlled studies.

Body in general: Frequent: syncope. Infrequent: hypothermia, allergic attack.

Heart: Frequent: cardiac failure. Infrequent: angina pectoris, bradycardia, myocardial infarction, thrombophlebitis, atrial fibrillation, hypotension, cardiac event, postural hypotension, lung embolism, lung edema.

Central and Peripheral Central Nervous System: Frequent: transient ischemic attack, cerebrovascular event, vertigo, ataxia, hypokinesia. Infrequent: paresthesia, convulsions, extrapyramidal disorder, hypertonia, tremor, aphasia, hypoesthesia, abnormal coordination, hemiplegia, hyperkinesia, involuntary muscle contractions, stupor, cerebral hemorrhage, neuralgia, ptosis, neuropathy.

Gastrointestinal System: Infrequent: gastroenteritis, diverticulitis, gastrointestinal hemorrhage, melena, esophageal ulceration.

Hemic and Lymphatic Disorders: Frequent: anemia. Infrequent: leukopenia.

Metabolic and Dietary Disorders: Frequent: elevated alkaline phosphatase, decreased weight. Infrequent: lack of fluids, hyponatremia, irritated diabetes.

Psychological Disorders: Frequent: aggressive reaction. Infrequent: delusion, personality disorder, emotional lability, nervousness, sleep problem, libido elevated, psychosis, amnesia, indifference, paranoid reaction, thinking abnormal, crying abnormal, appetite elevated, paroniria, delirium, depersonalization, neurosis, suicide attempt.

Respiratory system System: Frequent: pneumonia. Infrequent: apnea, bronchial asthma, hemoptysis.

Skin and Appendages: Frequent: rash. Infrequent: skin ulceration, pruritus, cellulitis, eczema, eczema, erythematous rash, alopecia, hives.

Special Senses: Frequent: cataract, conjunctivitis. Infrequent: macula lutea degeneration, decreased visual skill, decreased hearing, tinnitus, blepharitis, blurred vision, corneal opacity, glaucoma, conjunctival hemorrhage, eye discomfort, retinal hemorrhage, xerophthalmia, diplopia, abnormal lacrimation, myopia, retinal detachment.

The Urinary System: Frequent: frequent micturition. Infrequent: dysuria, hematuria, urinary retention.

Occasions Reported After the Marketing of Namenda, both US and Ex-US

Although no causal relationship to memantine treatment has been discovered, the next adverse occasions happen to be considered to be temporally connected with memantine treatment and aren’t described elsewhere in labeling: aspiration pneumonia, asthenia, atrioventricular block, bone fracture, carpal tunnel, cerebral infarction, chest discomfort, cholelithiasis, claudication, colitis, deep venous thrombosis, depressed degree of awareness (including lack of awareness and rare reports of coma), dyskinesia, dysphagia, encephalopathy, gastritis, gastroesophageal reflux, grand mal convulsions, intracranial hemorrhage, hepatitis (including elevated ALT and AST and hepatic failure), hyperglycemia, hyperlipidemia, hypoglycemia, ileus, elevated INR, impotence, lethargy, malaise, myoclonus, neuroleptic malignant syndrome, acute pancreatitis, Parkinsonism, acute kidney failure (including elevated creatinine and kidney insufficiency), prolonged QT interval, trouble sleeping, sepsis, Stevens-Manley syndrome, suicidal ideation, sudden dying, supraventricular tachycardia, tachycardia, tardive dyskinesia, thrombocytopenia, and hallucinations (both visual and auditory).

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