The benefits of combination therapy with
NAMENDA (memantine HCl) + donepezil HCl 5-10 mg
-
Significant Benefits in Cognition†1
NAMENDA+donepezil significantly improved cognitive performance vs the decline seen with placebo+donepezil at 6 months (LOCF: P<0.001) -
Significant Benefits in Activities of Daily Living
†1
NAMENDA+donepezil showed significantly less decline in performing daily activities vs placebo+donepezil at 6 months (LOCF: P=0.03) -
Significant Benefits in Behavior†1
NAMENDA+donepezil demonstrated significant benefits in behavior at 6 months vs the decline seen with placebo+donepezil (LOCF: P=0.002) -
Benefits in Care Dependence†1
NAMENDA+donepezil demonstrated significant benefits in care dependence vs placebo+donepezil at endpoint in community-dwelling patients with moderate to severe Alzheimer's disease (LOCF: P=0.001) -
Benefits in Global Function†1
NAMENDA+donepezil demonstrated significant benefits in global function vs placebo+donepezil at 6 months
(LOCF: P=0.03)
† Study Description: Results of a randomized, multicenter, double-blind, placebo-controlled, parallel-group U.S. study investigating the efficacy of NAMENDA+donepezil in outpatients with moderate to severe Alzheimer’s disease (AD). The study involved 404 patients with probable AD, ≥50 years of age, with a Mini-Mental State Examination (MMSE) score of ≥5 to ≤14 points, who were on a stable donepezil regimen (5 or 10 mg/day) for at least 3 months prior to study entry. § Patients were randomized (1:1) to receive NAMENDA (n=203; 10 mg BID) or placebo (n=201) for 24 weeks; 322 patients (172 NAMENDA, 150 placebo) completed the study. Primary efficacy measures were the baseline-to-endpoint changes on the Severe Impairment Battery (SIB) and on the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL19). Primary data analyses were performed using the last observation carried forward (LOCF) approach for missing data; results were also analyzed using the observed cases (OC) approach.
§ Patients were required to be on donepezil therapy for at least 6 months prior to study entry.1
Adverse events reported in ≥ 5% of patients receiving NAMENDA+ARICEPT or Placebo+ARICEPT in a clinical study
| Adverse Events | NAMENDA + ARICEPT (n=202) | Placebo (n=201) + ARICEPT |
| Agitation | 9% | 12% |
| Confusion | 8% | 2% |
| Fall | 7% | 7% |
| Influenza-like symptoms | 7% | 6% |
| Dizziness | 7% | 8% |
| Headache | 6% | 2% |
| Urinary tract infections | 6% | 5% |
| Urinary incontinence | 5% | 3% |
| Accidental injury | 5% | 8% |
| Upper respiratory tract infection | 5% | 6% |
| Peripheral edema | 5% | 4% |
| Diarrhea | 4% | 8% |
| Fecal incontinence | 2% | 5% |
Dosing and Administration
The recommended maintenance dose is 20 mg/day (10 mg BID) after titration2:
- The recommended maintenance dose is reached by day 22 of therapy with a minimum interval of 1 week between
dose increases - Can be administered with or without food
- In patients with severe renal impairment, the dosage should be reduced to 10 mg/day (5 mg BID)
- NAMENDA should be administered with caution to patients with severe hepatic impairment2
NAMENDA is offered in a convenient Titration Pak for the first 4 weeks of therapy
NAMENDA is available on over 90% of Commercial Health Plans and Medicare Part D formularies3.
NAMENDA® (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
IMPORTANT SAFETY INFORMATION ABOUT NAMENDA
Contraindications- NAMENDA is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation
- Caregivers should be instructed in the recommended administration (twice per day for doses above 5 mg) and about dose escalation (minimum interval of one week between dose increases)
- NAMENDA has not been systematically evaluated in patients with a seizure disorder
- NAMENDA should be used with caution under conditions that raise urine pH (including alterations by diet, drugs and the clinical state of the patient). Alkaline urine conditions may decrease the urinary elimination of memantine, resulting in increased plasma levels and possible increase in adverse events
- NAMENDA should be administered with caution to patients with severe hepatic impairment
- A dosage reduction is recommended in patients with severe renal impairment
- The combined use of NAMENDA with other NMDA antagonists (eg, amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution
- In clinical trials, the most common adverse events occurring in at least 5% of patients treated with NAMENDA and at a greater frequency than placebo-treated patients were dizziness (7% vs 5%), confusion (6% vs 5%), headache (6% vs 3%) and constipation (5% vs 3%)
- Tariot PN, Farlow MR, Grossberg GT, Graham SM, McDonald S, Gergel I, for the Memantine Study Group. Memantine treatment in patients with moderate to severe Alzheimer's disease already receiving donepezil: a randomized controlled trial. JAMA. 2004;291:317-324.
- NAMENDA (memantine HCl) Prescribing Information. Forest Pharmaceuticals, Inc., St. Louis, Mo.
- MediMedia Formulary Compass™ as of January 2011. Data are subject to change. The status of "Covered" is representative of Tiers 1-5 and includes quantity limit, prior authorization and step edit restrictions.