Data from FDA - Curated by Toby Galbraith - Last updated 16 May 2017
FDA (Food and Drug Administration, USA)
PRECAUTIONS Information for Patients and Caregivers: Caregivers should be instructed in the
Neurological Conditions Seizures: Namenda has not been systematically evaluated in
In clinical trials of Namenda, seizures occurred in 0.2 % of patients treated with Namenda and 0.5 % of patients treated with placebo.
Namenda should be administered with
Drug-Drug Interactions N-methyl-D-aspartate (NMDA)
Effects of Namenda on substrates of microsomal enzymes: In vitro studies conducted with marker substrates of CYP450 enzymes (CYP1A2, - 2A6, -2 C9, - 2D6, - 2E1, - 3A4) showed
In addition, i n vitro studies indicate that at
Effects of inhibitors and/or substrates of microsomal enzymes on Namenda: Memantine is predominantly renally eliminated, and drugs that are substrates and/or inhibitors of the CYP450 system are not expected to alter the metabolism of memantine.
In a 24-week controlled
However, coadministration of Namenda and HCTZ/TA did not affect the bioavailability of either memantine or TA, and
In addition, coadministration of memantine with the antihyperglycemic drug Glucovance® (glyburide and metformin HCl) did not affect the pharmacokinetics of memantine, metformin and glyburide.
Furthermore, memantine did not modify the serum glucose lowering effect of Glucovance®. Drugs that make the
Therefore, alterations of
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
Hence, memantine should be used with
Carcinogenesis, Mutagenesis and
There was also
Pregnancy Pregnancy Category B: Memantine given orally to pregnant
Slight maternal toxicity, decreased pup weights and an
Slight maternal toxicity and decreased pup weights were also seen at this dose in a study in which
The no-effect dose for these effects was 6 mg/kg, which is 3 times the MRHD on a mg/ m 2 basis.
Memantine should be used during pregnancy only if the potential
Nursing Mothers It is not known whether memantine is excreted in human breast milk.
Because many drugs are excreted in human milk,
Pediatric Use There are
In actual practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior and the types of patients treated may differ.
Table 1 lists treatment-emergent signs and symptoms that were reported in at least 2 % of patients in placebo-controlled dementia trials and for which
The overall profile of
A comparison of supine and standing
Laboratory Changes: Namenda and placebo groups were compared with
These analyses revealed
ECG Changes: Namenda and placebo groups were compared with
These analyses revealed
Clinical Trials Namenda has been administered to approximately 1350 patients with dementia, of whom more than 1200 received the maximum
Patients received Namenda treatment for periods of up to 884 days, with 862 patients receiving at least 24 weeks of treatment and 387 patients receiving 48 weeks or more of treatment.
Treatment emergent signs and symptoms that occurred during 8
To provide an overall estimate of the proportion of individuals having similar types of events, the events were grouped into a smaller number of standardized categories using WHO terminology, and event frequencies were calculated across all studies.
Events are classified by body system and listed using the following definitions: frequent
Body as a Whole: Frequent: syncope.
Cardiovascular System: Frequent: cardiac
Hemic and Lymphatic
Metabolic and Nutritional
Respiratory System: Frequent: pneumonia.
Skin and Appendages:
Urinary System: Frequent: frequent micturition.
Events Reported Subsequent to the Marketing of Namenda, both US and Ex-US Although
DOSAGE AND ADMINISTRATION The dosage of Namenda (memantine hydrochloride) shown to be
Namenda can be taken with or without food.
Patients/caregivers should be instructed on how to use the Namenda Oral Solution dosing device.
They should be made
Patients/caregivers should be instructed to address any questions on the usage of the solution to their physician or pharmacist.
Cockroft-Gault equation): For males: CLcr = [140-age (years)] · Weight (kg)/[72 · serum creatinine (mg/dL)] For females: CLcr = 0.85 · [140-age (years)] · Weight (kg)/[72 · serum creatinine (mg/dL)]
|Date Last Revised||05-11-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||PD-Rx Pharmaceuticals, Inc.|