• RxList Logo

Slideshows
Images
Quizzes
  • Privacy Policy
  • About Us
  • Contact Us
  • Terms of Use
  • Advertising Policy

  • This website is certified by Health On the Net Foundation. Click to verify.

  • TRUSTe

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information .

Namenda

  • Generic Name: memantine hcl
  • Brand Name: Namenda
Last reviewed on RxList: 1/17/2017

home
drugs a-z list
side effects drug center namenda (memantine hcl) drug

Dementia, Alzheimer's, and Aging Brains 

Dementia Slideshow Pictures

Alzheimer's Disease:A Caregiver's Guide

Alzheimer’s Disease Slideshow Pictures

RxList

Take the Alzheimer’s Quiz

Drug Description

Find Lowest Prices on

NAMENDA
(memantine HCl) Oral Solution

DESCRIPTION

NAMENDA (memantine
hydrochloride) is an orally active NMDA receptor antagonist . The chemical name
for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride
with the following structural formula:

NAMENDA (memantine HCl) Structural Formula Illustration

The molecular formula is C12H21N•HCl
and the molecular weight is 215.76. Memantine HCl occurs as a fine white to
off-white powder and is soluble in water.

NAMENDA oral solution contains
memantine hydrochloride in a strength equivalent to 2 mg of memantine
hydrochloride in each mL. The oral solution also contains the following
inactive ingredients: sorbitol solution (70%), methylparaben, propylparaben,
propylene glycol, glycerin, natural peppermint flavor #104, citric acid, sodium
citrate, and purified water.

Indications & Dosage

INDICATIONS

NAMENDA (memantine hydrochloride) is indicated for the
treatment of moderate to severe dementia of the Alzheimer’s type.

DOSAGE AND ADMINISTRATION

The recommended starting dose of NAMENDA is 5 mg (2.5 mL)
once daily. The dose should be increased in 5 mg increments to 10 mg/day (2.5
mL twice daily), 15 mg/day (2.5 mL and 5 mL as separate doses), and 20 mg/day
(5 mL twice daily). The minimum recommended interval between dose increases is
one week. The dosage shown to be effective in controlled clinical trials is 20
mg/day (5 mL twice daily).

Dosing Titration Schedule

 Total daily doseStrength per dose (mg)
Starting Dose5 mg5mg
Dose after week 110 mg5 mg (first daily dose)
5 mg (second daily dose)
Dose after week 215 mg5 mg (first daily dose)
10 mg (second daily dose)
Dose after week 320 mg10 mg (first daily dose)
10 mg (second daily dose)

NAMENDA can be taken with or
without food. If a patient misses a single dose of NAMENDA, that patient should
not double up on the next dose. The next dose should be taken as scheduled. If
a patient fails to take NAMENDA for several days, dosing may need to be resumed
at lower doses and retitrated as described above.

Do not mix NAMENDA oral
solution with any other liquid. NAMENDA is administered with a dosing device
that comes with the drug and consists of a syringe, syringe adaptor cap, tubing
and other supplies a patient needs to administer the drug. The supplied syringe
should be used to withdraw the correct volume of oral solution and the oral
solution should be slowly squirted into the corner of the patient’s mouth.

Special Populations

Renal Impairment

A target dose of 5 mg (2.5 mL)
twice daily is recommended in patients with severe renal impairment (creatinine
clearance of 5 – 29 mL/min based on the Cockcroft-Gault equation).

Hepatic Impairment

NAMENDA should be administered
with caution to patients with severe hepatic impairment [see CLINICAL
PHARMACOLOGY
].

HOW SUPPLIED

Dosage Forms And Strengths

NAMENDA 2 mg/mL oral solution: clear, alcohol-free,
sugar-free, and peppermint flavored.

Storage And Handling

2 mg/mL Oral Solution

12 fl. oz. (360 mL) bottle NDC #0456-3202-12

Store NAMENDA oral solution at 25°C (77°F); excursions
permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured for: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC St. Louis, MO
63045. Manufactured by: Forest Laboratories Ireland Ltd. Revised August 2014

Side Effects

SIDE EFFECTS

Clinical Trials Experience

NAMENDA was evaluated in eight double-blind
placebo-controlled trials involving a total of 1862 dementia (Alzheimer’s
disease, vascular dementia ) patients (940 patients treated with NAMENDA and 922
patients treated with placebo) for a treatment period up to 28 weeks.

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in clinical practice.

Adverse Events Leading to Discontinuation

In placebo-controlled trials in which dementia patients
received doses of NAMENDA up to 20 mg/day, the likelihood of discontinuation
because of an adverse reaction was the same in the NAMENDA group (10.1%) as in
the placebo group (11.5%). No individual adverse reaction was associated with
the discontinuation of treatment in 1% or more of NAMENDA-treated patients and
at a rate greater than placebo.

Most Common Adverse Reactions

In double-blind placebo-controlled trials involving
dementia patients, the most common adverse reactions (incidence ≥ 5% and
higher than placebo) in patients treated with NAMENDA were dizziness, headache,
confusion and constipation. Table 1 lists all adverse reactions that occurred
in at least 2% of patients treated with NAMENDA and at an incidence greater
than placebo.

Table 1: Adverse Reactions Reported in Controlled
Clinical Trials in at Least 2% of Patients Receiving NAMENDA and at a Higher
Frequency than Placebo-treated Patients

Adverse ReactionPlacebo
(N = 922) %
NAMENDA
(N = 940) %
Body as a Whole
  Fatigue12
  Pain13
Cardiovascular System
  Hypertension24
Central and Peripheral Nervous System
  Dizziness57
  Headache36
Gastrointestinal System
  Constipation35
  Vomiting23
Musculoskeletal System
  Back pain23
Psychiatric Disorders
  Confusion56
  Somnolence23
  Hallucination  23
Respiratory System
  Coughing34
  Dyspnea12

The overall profile of adverse
reactions and the incidence rates for individual adverse reactions in the
subpopulation of patients with moderate to severe Alzheimer’s disease were not
different from the profile and incidence rates described above for the overall
dementia population.

Seizures

NAMENDA has not been
systematically evaluated in patients with a seizure disorder. In clinical
trials of NAMENDA, seizures occurred in 0.2% of patients treated with NAMENDA
and 0.5% of patients treated with placebo.

Postmarketing Experience

The following adverse reactions
have been identified during post-approval use of memantine . Because these
reactions are reported voluntarily from a population of uncertain size, it is
not always possible to reliably estimate their frequency or establish a causal
relationship to drug exposure. These reactions include:

Blood and Lymphatic System
Disorders –
agranulocytosis , leukopenia
(including neutropenia ), pancytopenia , thrombocytopenia , thrombotic
thrombocytopenic purpura .

Cardiac Disorders –cardiac failure congestive.

Gastrointestinal Disorders – pancreatitis .

Hepatobiliary Disorders – hepatitis .

Psychiatric Disorders –suicidal ideation.

Renal and Urinary Disorders – acute renal failure
(including increased creatinine and renal insufficiency).

Skin Disorders –Stevens Johnson syndrome.

Drug Interactions

DRUG INTERACTIONS

Drugs That Make The Urine Alkaline

The clearance of memantine was reduced by about 80% under
alkaline urine conditions at pH 8. Therefore, alterations of urine pH towards
the alkaline condition may lead to an accumulation of the drug with a possible
increase in adverse effects. 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 severe infections of the urinary tract ). Hence,
memantine should be used with caution under these conditions.

Use With Other N-methyl-D-aspartate (NMDA) Antagonists

The combined use of NAMENDA with other NMDA antagonists
( amantadine , ketamine , and dextromethorphan ) has not been systematically
evaluated and such use should be approached with caution.

Warnings & Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Genitourinary Conditions

Conditions that raise urine pH may decrease the urinary
elimination of memantine resulting in increased plasma levels of memantine [see
DRUG INTERACTIONS ].

Patient Counseling Information

See FDA-approved patient labeling ( PATIENT INFORMATION and Instructions for Use).

To assure safe and effective use of NAMENDA, the
following information and instructions provided in the patient information
section should be discussed with patients and caregivers.

Patients/caregivers should be instructed to follow the
dose titration schedule provided by their physician or healthcare professional
for NAMENDA.

If a patient misses a single dose of NAMENDA, that
patient should not double up on the next dose. The next dose should be taken as
scheduled. If a patient fails to take NAMENDA for several days, dosing should
not be resumed without consulting that patient’s healthcare professional.

Patients/caregivers should be instructed on how to use
the NAMENDA oral solution dosing device. They should be made aware of the
patient instruction sheet that is enclosed with the product.
Patients/caregivers should be instructed to address any questions on the usage
of the solution to their physician or pharmacist.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

There was no evidence of carcinogenicity in a 113-week
oral study in mice at doses up to 40 mg/kg/day (10 times the maximum
recommended human dose [MRHD] on a mg/m² basis). There was also no evidence of
carcinogenicity in rats orally dosed at up to 40 mg/kg/day for 71 weeks
followed by 20 mg/kg/day (20 and 10 times the MRHD on a mg/m² basis,
respectively) through 128 weeks.

Memantine produced no evidence of genotoxic potential
when evaluated in the in vitro S. typhimurium or E. coli reverse
mutation assay, an in vitro chromosomal aberration test in human lymphocytes,
an in vivo cytogenetics assay for chromosome damage in rats, and the in vivo mouse
micronucleus assay. The results were equivocal in an in vitro gene mutation
assay using Chinese hamster V79 cells.

No impairment of fertility or reproductive performance
was seen in rats administered up to 18 mg/kg/day (9 times the MRHD on a mg/m² basis)
orally from 14 days prior to mating through gestation and lactation in females,
or for 60 days prior to mating in males.

Use In Specific Populations

Pregnancy

Pregnancy Category B

There are no adequate and well-controlled studies of memantine
in pregnant women. NAMENDA should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.

Memantine given orally to pregnant rats and pregnant
rabbits during the period of organogenesis was not teratogenic up to the
highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which
are 9 and 30 times, respectively, the maximum recommended human dose [MRHD] on
a mg/m² basis).

Slight maternal toxicity, decreased pup weights and an
increased incidence of non-ossified cervical vertebrae were seen at an oral
dose of 18 mg/kg/day in a study in which rats were given oral memantine
beginning pre-mating and continuing through the postpartum period. Slight
maternal toxicity and decreased pup weights were also seen at this dose in a
study in which rats were treated from day 15 of gestation through the
postpartum period. The no-effect dose for these effects was 6 mg/kg, which is 3
times the MRHD on a mg/m² basis.

Nursing Mothers

It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when NAMENDA is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not
been established.

Geriatric Use

The majority of people with Alzheimer’s disease are 65
years and older. In the clinical studies of NAMENDA the mean age of patients
was approximately 76; over 90% of patients were 65 years and older, 60% were 75
years and older, and 12% were at or above 85 years of age. The efficacy and
safety data presented in the clinical trial sections were obtained from these
patients. There were no clinically meaningful differences in most adverse
events reported by patient groups ≥ 65 years old and < 65 year old.

Renal Impairment

No dosage adjustment is needed in patients with mild or
moderate renal impairment. A dosage reduction is recommended in patients with
severe renal impairment [see DOSAGE AND ADMINISTRATION and CLINICAL
PHARMACOLOGY
].

Hepatic Impairment

No dosage adjustment is needed in patients with mild or
moderate hepatic impairment. NAMENDA should be administered with caution to
patients with severe hepatic impairment [see DOSAGE AND ADMINISTRATION and
CLINICAL PHARMACOLOGY ].

Overdosage & Contraindications

OVERDOSE

Signs and symptoms most often accompanying memantine
overdosage in clinical trials and from worldwide marketing experience, alone or
in combination with other drugs and/or alcohol, include agitation, asthenia ,
bradycardia , confusion, coma, dizziness, ECG changes, increased blood pressure,
lethargy , loss of consciousness, psychosis , restlessness, slowed movement,
somnolence , stupor, unsteady gait , visual hallucinations, vertigo , vomiting,
and weakness. The largest known ingestion of memantine worldwide was 2.0 grams
in a patient who took memantine in conjunction with unspecified antidiabetic
medications. The patient experienced coma, diplopia , and agitation, but
subsequently recovered. Fatal outcome has been very rarely reported with
memantine, and the relationship to memantine was unclear.

Because strategies for the management of overdose are
continually evolving, it is advisable to contact a poison control center to
determine the latest recommendations for the management of an overdose of any
drug. As in any cases of overdose, general supportive measures should be
utilized, and treatment should be symptomatic. Elimination of memantine can be
enhanced by acidification of urine.

CONTRAINDICATIONS

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

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Mechanism Of Action

Persistent activation of
central nervous system N-methyl-D-aspartate (NMDA) receptors by the excitatory
amino acid glutamate has been hypothesized to contribute to the symptomatology
of Alzheimer’s disease . Memantine is postulated to exert its therapeutic effect
through its action as a low to moderate affinity uncompetitive (open-channel)
NMDA receptor antagonist which binds preferentially to the NMDA
receptor-operated cation channels. There is no evidence that memantine prevents
or slows neurodegeneration in patients with Alzheimer’s disease.

Pharmacodynamics

Memantine showed low to
negligible affinity for GABA, benzodiazepine, dopamine , adrenergic, histamine
and glycine receptors and for voltage-dependent Ca2+, Na+ or K+ channels.
Memantine also showed antagonistic effects at the 5HT3 receptor with a potency
similar to that for the NMDA receptor and blocked nicotinic acetylcholine
receptors with one-sixth to one-tenth the potency.

In vitro studies have shown that memantine does not
affect the reversible inhibition of acetylcholinesterase by donepezil ,
galantamine , or tacrine.

Pharmacokinetics

Absorption

Following oral administration memantine is highly
absorbed with peak concentrations reached in about 3-7 hours. Memantine has
linear pharmacokinetics over the therapeutic dose range. Food has no effect on
the absorption of memantine.

Distribution

The mean volume of distribution of memantine is 9-11 L/kg
and the plasma protein binding is low (45%).

Metabolism

Memantine undergoes partial hepatic metabolism . The
hepatic microsomal CYP450 enzyme system does not play a significant role in the
metabolism of memantine.

Elimination

Memantine is excreted predominantly (about 48%) unchanged
in urine and has a terminal elimination half-life of about 60-80 hours.

The remainder is converted primarily to three polar
metabolites which possess minimal NMDA receptor antagonistic activity: the
N-glucuronide conjugate, 6-hydroxy memantine, and 1-nitroso-deaminated
memantine. A total of 74% of the administered dose is excreted as the sum of
the parent drug and the Nglucuronide conjugate. Renal clearance involves active
tubular secretion moderated by pH dependent tubular reabsorption.

Pharmacokinetics in Specific Populations

Gender

Following multiple dose administration of NAMENDA 20 mg
daily, females had about 45% higher exposure than males, but there was no
difference in exposure when body weight was taken into account.

Elderly

The pharmacokinetics of NAMENDA in young and elderly
subjects are similar.

Renal Impairment

Memantine pharmacokinetics were evaluated following
single oral administration of 20 mg memantine HCl in 8 subjects with mild renal
impairment (creatinine clearance, CLcr, > 50 – 80 mL/min), 8 subjects with
moderate renal impairment (CLcr 30 – 49 mL/min), 7 subjects with severe renal
impairment (CLcr 5 – 29 mL/min) and 8 healthy subjects (CLcr > 80 mL/min)
matched as closely as possible by age, weight and gender to the subjects with
renal impairment. Mean AUC0-∞ increased by 4%, 60%, and 115% in subjects
with mild, moderate, and severe renal impairment, respectively, compared to
healthy subjects. The terminal elimination half-life increased by 18%, 41%, and
95% in subjects with mild, moderate, and severe renal impairment, respectively,
compared to healthy subjects.

No dosage adjustment is recommended for patients with
mild and moderate renal impairment. Dosage should be reduced in patients with
severe renal impairment [see DOSAGE AND ADMINISTRATION ].

Hepatic Impairment

Memantine pharmacokinetics were evaluated following the
administration of single oral doses of 20 mg in 8 subjects with moderate
hepatic impairment (Child-Pugh Class B, score 7-9) and 8 subjects who were
age-, gender-, and weight-matched to the hepatically-impaired subjects. There
was no change in memantine exposure (based on Cmax and AUC) in subjects with
moderate hepatic impairment as compared with healthy subjects. However,
terminal elimination half-life increased by about 16% in subjects with moderate
hepatic impairment as compared with healthy subjects. No dose adjustment is
recommended for patients with mild and moderate hepatic impairment. Memantine
should be administered with caution to patients with severe hepatic impairment
as the pharmacokinetics of memantine have not been evaluated in that
population.

Drug-Drug Interactions

Use with Cholinesterase Inhibitors

Coadministration of memantine with the AChE inhibitor
donepezil HCl did not affect the pharmacokinetics of either compound.
Furthermore, memantine did not affect AChE inhibition by donepezil. In a
24-week controlled clinical study in patients with moderate to severe
Alzheimer’s disease, the adverse event profile observed with a combination of
NAMENDA and donepezil was similar to that of donepezil alone.

Effect of NAMENDA on the Metabolism of Other Drugs

In vitro studies conducted with marker substrates of
CYP450 enzymes (CYP1A2, -2A6, -2C9, -2D6, 2E1, -3A4) showed minimal inhibition
of these enzymes by memantine. In addition, in vitro studies indicate that at
concentrations exceeding those associated with efficacy, memantine does not
induce the cytochrome P450 isozymes CYP1A2, -2C9, -2E1 and -3A4/5. No
pharmacokinetic interactions with drugs metabolized by these enzymes are
expected.

Pharmacokinetic studies evaluated the potential of
memantine for interaction with warfarin, and buproprion. Memantine did not
affect the pharmacokinetics of the CYP2B6 substrate buproprion or its
metabolite hydroxybuproprion. Furthermore, memantine did not affect the
pharmacokinetics or pharmacodynamics of warfarin as assessed by the prothrombin
INR.

Effect of Other Drugs 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.

Drugs Eliminated via Renal Mechanisms

Because memantine is eliminated in part by tubular secretion,
coadministration of drugs that use the same renal cationic system, including
hydrochlorothiazide (HCTZ), triamterene (TA), metformin , cimetidine ,
ranitidine , quinidine, and nicotine , could potentially result in altered plasma
levels of both agents. However, coadministration of NAMENDA and HCTZ/TA did not
affect the bioavailability of either memantine or TA, and the bioavailability
of HCTZ decreased by 20%. 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®,
indicating the absence of a pharmacodynamic interaction.

Drugs Highly Bound to Plasma Proteins

Because the plasma protein binding of memantine is low
(45%), an interaction with drugs that are highly bound to plasma proteins, such
as warfarin and digoxin , is unlikely.

Animal Toxicology And/Or Pharmacology

Memantine induced neuronal lesions (vacuolation and
necrosis ) in the multipolar and pyramidal cells in cortical layers III and IV
of the posterior cingulate and retrosplenial neocortices in rats, similar to
those which are known to occur in rodents administered other NMDA receptor
antagonists. Lesions were seen after a single dose of memantine. In a study in
which rats were given daily oral doses of memantine for 14 days, the no-effect
dose for neuronal necrosis was 6 times the maximum recommended human dose of 20
mg/day on a mg/m² basis

In acute and repeat-dose neurotoxicity studies in female
rats, oral administration of memantine and donepezil in combination resulted in
increased incidence, severity, and distribution of neurodegeneration compared
with memantine alone. The no-effect levels of the combination were associated
with clinically relevant plasma memantine and donepezil exposures.

The relevance of these findings to humans is unknown.

Clinical Studies

The clinical efficacy studies described below were
conducted with NAMENDA tablets and not with NAMENDA oral solution; however,
bioequivalence of NAMENDA oral solution with NAMENDA tablets has been
demonstrated.

The effectiveness of NAMENDA as a treatment for patients
with moderate to severe Alzheimer’s disease was demonstrated in 2 randomized,
double-blind, placebo-controlled clinical studies (Studies 1 and 2) conducted
in the United States that assessed both cognitive function and day to day
function. The mean age of patients participating in these two trials was 76
with a range of 50-93 years. Approximately 66% of patients were female and 91%
of patients were Caucasian. A third study (Study 3), carried out in Latvia,
enrolled patients with severe dementia , but did not assess cognitive function
as a planned endpoint. Study Outcome Measures: In each U.S. study, the effectiveness
of NAMENDA was determined using both an instrument designed to evaluate overall
function through caregiver-related assessment, and an instrument that measures
cognition . Both studies showed that patients on NAMENDA experienced significant
improvement on both measures compared to placebo.

Day-to-day function was assessed in both studies using
the modified Alzheimer’s disease Cooperative Study – Activities of Daily Living
inventory (ADCS-ADL). The ADCS-ADL consists of a comprehensive battery of ADL questions
used to measure the functional capabilities of patients. Each ADL item is rated
from the highest level of independent performance to complete loss. The
investigator performs the inventory by interviewing a caregiver familiar with
the behavior of the patient. A subset of 19 items, including ratings of the
patient’s ability to eat, dress, bathe, telephone, travel, shop, and perform
other household chores has been validated for the assessment of patients with
moderate to severe dementia. This is the modified ADCS-ADL, which has a scoring
range of 0 to 54, with the lower scores indicating greater functional
impairment.

The ability of NAMENDA to improve cognitive performance
was assessed in both studies with the Severe Impairment Battery ( SIB ), a multi-item
instrument that has been validated for the evaluation of cognitive function in
patients with moderate to severe dementia. The SIB examines selected aspects of
cognitive performance, including elements of attention, orientation, language,
memory, visuospatial ability, construction, praxis, and social interaction. The
SIB scoring range is from 0 to 100, with lower scores indicating greater
cognitive impairment.

Study 1 (Twenty-Eight-Week Study)

In a study of 28 weeks duration, 252 patients with
moderate to severe probable Alzheimer’s disease (diagnosed by DSM-IV and
NINCDS-ADRDA criteria, with Mini-Mental State Examination scores ≥ 3 and
≤ 14 and Global Deterioration Scale Stages 5-6) were randomized to
NAMENDA or placebo. For patients randomized to NAMENDA, treatment was initiated
at 5 mg once daily and increased weekly by 5 mg/day in divided doses to a dose
of 20 mg/day (10 mg twice a day).

Effects on the ADCS-ADL

Figure 1 shows the time course for the change from
baseline in the ADCS-ADL score for patients in the two treatment groups
completing the 28 weeks of the study. At 28 weeks of treatment, the mean
difference in the ADCS-ADL change scores for the NAMENDA-treated patients
compared to the patients on placebo was 3.4 units. Using an analysis based on
all patients and carrying their last study observation forward (LOCF analysis),
NAMENDA treatment was statistically significantly superior to placebo.

Figure 1: Time course of the
change from baseline in ADCS-ADL score for patients completing 28 weeks of
treatment.

Time course of the change from baseline in ADCS-ADL score - Illustration

Figure 2 shows the cumulative
percentages of patients from each of the treatment groups who had attained at
least the change in the ADCS-ADL shown on the X axis . The curves show that both
patients assigned to NAMENDA and placebo have a wide range of responses and
generally show deterioration (a negative change in ADCS-ADL compared to
baseline), but that the NAMENDA group is more likely to show a smaller decline
or an improvement. (In a cumulative distribution display, a curve for an effective
treatment would be shifted to the left of the curve for placebo, while an
ineffective or deleterious treatment would be superimposed upon or shifted to
the right of the curve for placebo).

Figure 2: Cumulative
percentage of patients completing 28 weeks of double-blind treatment with
specified changes from baseline in ADCS-ADL scores.

Cumulative percentage of patients completing 28 weeks of double-blind treatment with specified changes from baseline in ADCS-ADL scores - Illustration

Effects on the SIB

Figure 3 shows the time course
for the change from baseline in SIB score for the two treatment groups over the
28 weeks of the study. At 28 weeks of treatment, the mean difference in the SIB
change scores for the NAMENDA-treated patients compared to the patients on
placebo was 5.7 units. Using an LOCF analysis, NAMENDA treatment was
statistically significantly superior to placebo.

Figure 3: Time course of the
change from baseline in SIB score for patients completing 28 weeks of
treatment.

Time course of the change from baseline in SIB score - Illustration

Figure 4 shows the cumulative
percentages of patients from each treatment group who had attained at least the
measure of change in SIB score shown on the X axis. The curves show that both
patients assigned to NAMENDA and placebo have a wide range of responses and
generally show deterioration, but that the NAMENDA group is more likely to show
a smaller decline or an improvement.

Figure 4: Cumulative
percentage of patients completing 28 weeks of double-blind treatment with
specified changes from baseline in SIB scores.

Cumulative percentage of patients completing 28 weeks of double-blind treatment with specified changes from baseline in SIB scores - Illustration

Study 2 (Twenty-Four-Week
Study)

In a study of 24 weeks
duration, 404 patients with moderate to severe probable Alzheimer’s disease
(diagnosed by NINCDS-ADRDA criteria, with Mini-Mental State Examination scores
≥ 5 and ≤ 14) who had been treated with donepezil for at least 6
months and who had been on a stable dose of donepezil for the last 3 months
were randomized to NAMENDA or placebo while still receiving donepezil. For
patients randomized to NAMENDA, treatment was initiated at 5 mg once daily and
increased weekly by 5 mg/day in divided doses to a dose of 20 mg/day (10 mg
twice a day).

Effects on the ADCS-ADL

Figure 5 shows the time course
for the change from baseline in the ADCS-ADL score for the two treatment groups
over the 24 weeks of the study. At 24 weeks of treatment, the mean difference
in the ADCS-ADL change scores for the NAMENDA/donepezil treated patients
(combination therapy) compared to the patients on placebo/donepezil
(monotherapy) was 1.6 units. Using an LOCF analysis, NAMENDA/donepezil
treatment was statistically significantly superior to placebo/donepezil.

Figure 5: Time course of the
change from baseline in ADCS-ADL score for patients completing 24 weeks of
treatment.

Time course of the change from baseline in ADCS-ADL score - Illustration

Figure 6 shows the cumulative
percentages of patients from each of the treatment groups who had attained at
least the measure of improvement in the ADCS-ADL shown on the X axis. The
curves show that both patients assigned to NAMENDA/donepezil and
placebo/donepezil have a wide range of responses and generally show
deterioration, but that the NAMENDA/donepezil group is more likely to show a
smaller decline or an improvement.

Figure 6: Cumulative
percentage of patients completing 24 weeks of double-blind treatment with specified
changes from baseline in ADCS-ADL scores.

Cumulative percentage of patients completing 24 weeks of double-blind treatment with specified changes from baseline in ADCS-ADL scores - Illustration

Effects on the SIB

Figure 7 shows the time course
for the change from baseline in SIB score for the two treatment groups over the
24 weeks of the study. At 24 weeks of treatment, the mean difference in the SIB
change scores for the NAMENDA/donepezil-treated patients compared to the
patients on placebo/donepezil was 3.3 units. Using an LOCF analysis,
NAMENDA/donepezil treatment was statistically significantly superior to
placebo/donepezil.

Figure 7: Time course of the
change from baseline in SIB score for patients completing 24 weeks of
treatment.

Time course of the change from baseline in SIB score - Illustration

Figure 8 shows the cumulative
percentages of patients from each treatment group who had attained at least the
measure of improvement in SIB score shown on the X axis. The curves show that
both patients assigned to NAMENDA/donepezil and placebo/donepezil have a wide
range of responses, but that the NAMENDA/donepezil group is more likely to show
an improvement or a smaller decline.

Figure 8: Cumulative
percentage of patients completing 24 weeks of double-blind treatment with
specified changes from baseline in SIB scores.

Cumulative percentage of patients completing 24 weeks of double-blind treatment with specified changes from baseline in SIB scores - Illustration

Study 3 (Twelve-Week Study)

In a double-blind study of 12
weeks duration, conducted in nursing homes in Latvia, 166 patients with
dementia according to DSM -III-R, a Mini-Mental State Examination score of <
10, and Global Deterioration Scale staging of 5 to 7 were randomized to either
NAMENDA or placebo. For patients randomized to NAMENDA, treatment was initiated
at 5 mg once daily and increased to 10 mg once daily after 1 week. The primary
efficacy measures were the care dependency subscale of the Behavioral Rating
Scale for Geriatric Patients (BGP), a measure of day-to-day function, and a
Clinical Global Impression of Change (CGI-C), a measure of overall clinical
effect. No valid measure of cognitive function was used in this study. A
statistically significant treatment difference at 12 weeks that favored NAMENDA
over placebo was seen on both primary efficacy measures. Because the patients
entered were a mixture of Alzheimer’s disease and vascular dementia , an attempt
was made to distinguish the two groups and all patients were later designated
as having either vascular dementia or Alzheimer’s disease, based on their
scores on the Hachinski Ischemic Scale at study entry. Only about 50% of the
patients had computerized tomography of the brain. For the subset designated as
having Alzheimer’s disease, a statistically significant treatment effect
favoring NAMENDA over placebo at 12 weeks was seen on both the BGP and CGI-C.

Medication Guide

PATIENT INFORMATION

NAMENDA
(Nuh-MEN-dah)
(memantine hydrochloride) Oral Solution

Read this Patient Information that comes with NAMENDA before
you start taking it and each time you get a refill. There may be new
information. This information does not take the place of talking to your doctor
about your medical condition or your treatment.

What is NAMENDA?

NAMENDA is a prescription medicine used for the treatment
of moderate to severe dementia in people with Alzheimer’s disease . NAMENDA
belongs to a class of medicines called NMDA (N-methyl-Daspartate) inhibitors.

It is not known if NAMENDA is safe and effective in
children.

Who should not take NAMENDA?

Do not take NAMENDA if you are allergic to
memantine or any of the ingredients in NAMENDA. See the end of this leaflet for
a complete list of ingredients in NAMENDA.

What should I tell my doctor before taking NAMENDA?

Before you take NAMENDA, tell your doctor if you:

  • have or have had seizures
  • have or have had problems passing urine
  • have or have had bladder or kidney problems
  • have liver problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known
    if NAMENDA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known
    if NAMENDA passes into your breast milk. You and your doctor should decide if
    you will take NAMENDA or breastfeed.

Tell your doctor about all the medicines you take,
including prescription and non-prescription medicines, vitamins, and herbal
supplements.

Taking NAMENDA with certain other medicines may affect
each other. Taking NAMENDA with other medicines can cause serious side effects.

Especially tell your doctor if you take:

  • other NMDA antagonists such as amantadine, ketamine, and
    dextromethorphan
  • medicines that make your urine alkaline such as carbonic
    anhydrase inhibitors and sodium bicarbonate

Ask your doctor or pharmacist for a list of these medicines,
if you are not sure.

Know the medicines you take. Keep a list of them to show
your doctor and pharmacist when you get a new medicine.

How should I take NAMENDA?

  • See the step-by-step instructions for taking NAMENDA
    at the end of this Patient Information.
  • Your doctor will tell you how much NAMENDA to take and
    when to take it.
  • Your doctor may change your dose if needed.
  • NAMENDA can be taken with food or without food.
  • If you forget to take one dose of NAMENDA, do not double
    up on the next dose. You should take only the next dose as scheduled.
  • If you have forgotten to take NAMENDA for several days,
    you should not take the next dose until you talk to your doctor.
  • If you take too much NAMENDA, call your doctor or poison
    control center at 1-800-222-1222 right away, or go to the nearest hospital
    emergency room.

What are the possible side effects of NAMENDA?

NAMENDA may cause side effects, including:

The most common side effects of NAMENDA include:

  • dizziness
  • headache
  • confusion
  • constipation

These are not all the possible side effects of NAMENDA.
For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1800-FDA-1088.

How should I store NAMENDA?

  • Store NAMENDA at room temperature between 68°F to 77°F
    (20°C to 25°C).

What are the ingredients in NAMENDA?

Active ingredients: memantine hydrochloride

Inactive ingredients: sorbitol solution (70%), methyl
paraben, propylparaben, propylene glycol, glycerin , natural peppermint flavor
#104, citric acid, sodium citrate, and purified water

Keep NAMENDA and all medicines out of the reach of
children.

General information about the safe and effective use
of NAMENDA.

Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not take NAMENDA for a
condition for which it was not prescribed. Do not give NAMENDA to other people,
even if they have the same condition. It may harm them.

This Patient Information leaflet summarizes the most
important information about NAMENDA. If you would like more information, talk
with your doctor. You can ask your doctor or pharmacist for information about NAMENDA
that was written for healthcare professionals.

For more information about NAMENDA, go to www.namenda.com,
or call Forest Laboratories, Inc. at 1-800-678-1605.

INSTRUCTIONS FOR USE

NAMENDA
(Nuh-MEN-dah)
(memantine hydrochloride) Oral Solution

Directions for Using your NAMENDA Oral Solution

Read these instructions before taking NAMENDA Oral
Solution and each time you get a refill. There may be new information. This
information does not take the place of talking to your doctor about your
medical condition or your treatment.

Preparing your dose of NAMENDA Oral Solution.

You will need the following supplies:

  1. NAMENDA Oral Solution bottle with Child-resistant cap
  2. Green syringe adaptor cap with lid
  3. Oral dosing syringe
  4. Prescribing Information

pSupplies needed for Preparing your dose of NAMENDA Oral Solution - Illustration

1. Remove the oral dosing syringe, the green syringe
adaptor cap, and remove the plastic tube from its protective plastic bag.
Attach the tube to the green syringe adaptor cap if it is not already attached.

The green syringe adaptor cap - Illustration

2. The bottle comes with a child-resistant cap. To remove
the cap, you should push down on the cap and at the same time; turn the cap
counter-clockwise (to the left).

Child-resistant cap - Illustration

3. Carefully remove the seal from the bottle and throw
away.

Remove the seal - Illustration

4. Insert the green syringe adaptor cap, with the
attached tube, all the way into the bottle and tightly screw the cap onto the
bottle by turning the cap clockwise (to the right).

Insert the green syringe adaptor cap - Illustration

5. The green syringe adaptor cap has an opening with an attached lid. The adaptor
is used to withdraw the correct dose of medicine from the bottle with the
syringe. The attached adaptor lid should be closed in between doses.

The green syringe adaptor cap has an opening with an attached lid - Illustration

6.  Keep the bottle upright on a table. Open the syringe
adaptor lid and insert the tip of syringe into the syringe adaptor opening

  • Make sure the syringe is pushed firmly into the adaptor
    opening.

syringe is pushed firmly into the adaptor opening - Illustration

7. While holding the syringe in place, gently pull the
plunger of the syringe until you get to the correct mL (amount) of medicine you
need.

  • Do not worry about a few tiny bubbles. This will not
    affect your dose.

gently pull the plunger - Illustration

8. Remove the syringe from the syringe adaptor cap.

Remove the syringe from the syringe adaptor cap - Illustration

9. Remove the syringe from the bottle and slowly squirt
the NAMENDA Oral Solution into the corner of you or the patient’s mouth. Do
not mix NAMENDA Oral Solution with any other liquid.

Slowly squirt the NAMENDA Oral Solution into the corner of you or the patient’s mouth - Illustration

10. After use, reseal the bottle by snapping the attached
syringe adaptor lid closed.

Reseal the bottle - Illustration

11. Rinse the empty syringe by inserting the open end of
the syringe into a glass of water, pulling the plunger out to draw in water,
and pushing the plunger in to remove the water. Repeat several times. Allow the
syringe to air dry.

Rinse the empty syringe - Illustration

12. Store the bottle upright.

Store the bottle upright - Illustration

From WebMD Logo

Healthy Resources
  • 10 Tips for Senior Health
  • How Is Atrial Fibrillation Affecting You?
  • Cancer Treatment: What to Expect
Featured Centers
  • How Is Your MS Care Routine? Assess Yourself
Health Solutions From Our Sponsors
  • Kept Your Wisdom Teeth?
  • What is TAVR?
FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Health Solutions From Our Sponsors

  • Nutritious Milk Substitute
  • Open Heart Alternatives 
  • Cancer: Second Opinions
  • Penis Curved When Erect
  • Diarrhea Solutions
  • Severe Aortic Stenosis?
  • Benefits of Probiotics
  • Get Help with ED
  • Diabetes Management
  • Probiotic Supplements
  • Low Sugar Dairy Drink
  • How Drugs Rewire Brains
  • Affordable ED Meds
  • Improving Digestion
  • Valve Disease Treatment
  • Tips to Beat Heartburn


Pill Identifier Tool Quick, Easy, Pill Identification

Drug Interaction Tool Check Potential Drug Interactions

Pharmacy Locater Tool Including 24 Hour, Pharmacies

Namenda XR Drug Imprint

004563205_PB

oval, brown, imprinted with 5, FL

004563210_PB

oval, gray, imprinted with 10, FL

004563407_PB

capsule, yellow, imprinted with FLI 7 mg

004563428_PB

capsule, green, imprinted with FLI 28 mg

  • Related Drugs

    Amyvid
    Aricept
    Axona
    Namenda XR
    Namzaric
    Neuraceq
    Razadyne ER
    Vizamyl

  • Health Resources

    Dementia
    Alzheimer’s Disease FAQs

  • Related Supplements

    Acetyl-L-Carnitine
    Lemon Balm
    Phosphatidylserine
    Sage
    Vinpocetine

Namenda User Reviews

Featured Slideshows

  • SleepWhat Are the Best Sleeping Positions?

  • Heart DiseaseHeart Attack vs. Cardiac Arrest vs. Heart Failure

  • Psoriasis: See what it looks like and how to treat it

    PsoriasisWhat Does a Psoriasis Rash Look Like?