NAMENDA XR 28 mg+AChEI demonstrated efficacy in cognition and global function in moderate to severe Alzheimer's disease

Significant improvement in cognition

  • Combination therapy with NAMENDA XR 28 mg+AChEI demonstrated greater improvement in cognition vs placebo+AChEI treatment at 24 weeks using an LOCF analysis1

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Significant improvement in global function

  • Combination therapy with NAMENDA XR 28 mg+AChEI demonstrated greater improvement in global function vs placebo+AChEI treatment at 24 weeks, using an LOCF analysis1

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Two pathways to treatment

Acetylcholine and glutamate pathways


combination therapy system progression


  • There is no evidence that memantine or an AChEI prevents or slows neurodegeneration in patients with Alzheimer's disease1,7-9
  • NAMENDA XR has a distinct mechanism of action from the AChEIs. Together, the 2 deliver additive benefits in cognition and global function vs an AChEI alone1

References:

  1. NAMENDA XR (memantine HCl) extended-release Prescribing Information. Cincinnati, OH: Forest Pharmaceuticals, Inc.; 2014.
  2. Francis PT, Palmer AM, Snape M, Wilcock GK. The cholinergic hypothesis of Alzheimer's disease: a review of progress. J Neurol Neurosurg Psychiatry. 1999;66:137-147.
  3. Whitehouse PJ, Price DL, Clark AW, Coyle JT, DeLongi MR. Alzheimer disease: evidence for selective loss of cholinergic neurons in the nucleus basalis. Ann Neurol. 1981;10:122-126.
  4. Giacobini E. Modulation of brain acetylcholine levels with cholinesterase inhibitors as a treatment of Alzheimer disease. Keio J Med. 1987;36:381-391.
  5. Doraiswamy PM. Non-cholinergic strategies for treating and preventing Alzheimer's disease. CNS Drugs. 2002;16:811-824.
  6. Danysz W, Parsons CG, Möbius H-J, Stöffler A, Quack G. Neuroprotective and symptomatological action of memantine relevant for Alzheimer's disease—a unified glutamatergic hypothesis on the mechanism of action. Neurotox Res. 2000;2:85-97.
  7. Aricept® (donepezil hydrochloride) tablets Prescribing Information. Eisai Inc., Woodcliff Lake, NJ.
  8. Razadyne® (galantamine HBr) Prescribing Information. Ortho-McNeil Neurologics, Inc., Titusville, NJ.
  9. Exelon® (rivastigmine tartrate) Prescribing Information. Novartis Pharmaceuticals Corporation, East Hanover, NJ.

NAMENDA XR® (memantine hydrochloride) extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

Important Safety Information

Contraindications

  • NAMENDA XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.

Warnings and Precautions

  • Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine.

Adverse Reactions

  • The most commonly observed adverse reactions in patients administered NAMENDA XR (28 mg/day) in a 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 (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).
  • NAMENDA XR has not been systematically evaluated in patients with a seizure disorder.

Drug Interactions

  • Alterations of urine pH toward the alkaline condition may lead to an accumulation of memantine with a possible increase in adverse reactions. NAMENDA XR should be used with caution under conditions that may be associated with increased urine pH including alterations by diet, drugs, and the clinical state of the patient.
  • No drug-drug interaction studies have been conducted with NAMENDA XR, specifically. The combined use of NAMENDA XR with other NMDA antagonists (amantadine, ketamine, or dextromethorphan) has not been systematically evaluated and such use should be approached with caution.

Dosage and Administration

  • The recommended starting dose of NAMENDA XR is 7 mg once daily. The recommended target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week, and only if the previous dose has been well tolerated. The maximum recommended dose is 28 mg once daily.
  • It is recommended that a patient who is on a regimen of 10 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 28 mg once-daily capsules the day following the last dose of a 10 mg NAMENDA tablet. There is no study addressing the comparative efficacy of these 2 regimens.
  • It is recommended that a patient with severe renal impairment who is on a regimen of 5 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 14 mg once-daily capsules the day following the last dose of a 5 mg NAMENDA tablet.

Special Populations

  • NAMENDA XR should be administered with caution to patients with severe hepatic impairment.
  • A target dose of 14 mg/day is recommended in patients with severe renal impairment (creatinine clearance of 5-29 mL/min, based on the Cockcroft-Gault equation).