About NAMENDA XR®

For patients with moderate to severe Alzheimer's disease

Treat today with NAMENDA XR.

Once-daily NAMENDA XR 28 mg+AChEI* demonstrated improvements in cognition
and global function

  • In a 24-week study of 677 outpatients with moderate to severe AD on stable AChEI therapy, adding NAMENDA XR 28 mg was statistically significantly superior to placebo+AChEI (using an LOCF analysis) in the primary co-endpoints of1:
    • Cognition as measured by the Severe Impairment Battery (2.6 unit mean difference)1
    • Global function as measured by the Clinician's Interview-Based Impression of Change
      plus caregiver input (0.3 unit mean difference)1
  • Studied in combination with leading AChEIs (donepezil, galantamine, or rivastigmine)1

Convenient once-daily dosing with NAMENDA XR

  • No titration required when switching from NAMENDA® (memantine HCl) to NAMENDA XR1
  • Once-daily dosing aligns with once-daily AChEI regimens2
    • Patients taking combination therapy with a once-daily AChEI may be able to receive all Alzheimer's disease treatments once per day

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.

Adverse Reactions

  • The most commonly observed adverse reactions occurring at a frequency of at least 5% in NAMENDA XR-treated patients and at a higher frequency than placebo were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).1
  • In the placebo-controlled clinical trial of NAMENDA XR (N=676), the proportions of patients in the NAMENDA XR 28 mg/day dose and placebo groups who discontinued treatment due to adverse events were 10.0% and 6.3%, respectively.
  • The most common adverse reaction in the NAMENDA XR-treated group that led to treatment discontinuation in this study was dizziness at a rate of 1.5%.
  • AChEI=acetylcholinesterase inhibitor.
  • LOCF=last observation carried forward.
  • Aricept® is a registered trademark of Eisai Co., Ltd.
  • Exelon® is a registered trademark of Novartis AG Corp.
  • Razadyne® is a registered trademark of Johnson & Johnson.

References:

  1. NAMENDA XR (memantine HCl) extended-release Prescribing Information. Cincinnati, OH: Forest Pharmaceuticals, Inc.; 2014.
  2. Data on file. Forest Laboratories, LLC

Review the benefits of combination therapy with NAMENDA XR

Read about once-daily dosing with NAMENDA XR

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).