Product Information: Memantine - Ebixa
|Memantine Tablets - Ebixa
|Memantine Liquid - Ebixa
The very latest approach for Alzheimer's disease
is a novel new drug that is showing a lot of promise in the battle against
Alzheimer's disease. Although it has been in use in Germany for nearly
10-years (5), it is only recent clinical trials that has highlighted many
of its unique properties, particularly for its use in senile dementia.
The majority of current drugs that treat Alzheimer's disease, such as
Galantamine, do so by inhibiting an enzyme called acetylcholinesterase.
This enzyme breaks down the brain neurotransmitter- acetylcholine. It
is acetylcholine that is badly affected in Alzheimer's patients. (It is
interesting to note that Memantine appears to be capable of being used
alongside such drugs- see reference 1).
Memantine works very differently, it inhibits receptors known as N-Methyl-D-Aspartate
or NMDA, because these receptors may underlie the degeneration of cholinergic
cells (1). Cholinergic cells are essential for healthy brain function
and are also badly affected in Alzheimer's disease.
Over stimulation of NMDA receptors is referred to under the term of excitotoxicity,
and excitotoxicity was referred to in a 1994 review (3) as; "The
final common pathway for all neurologic disorders." Now even more
evidence is accumulating that over activity of NMDA receptors is detrimental
to mental health (4). However, experiments have shown that Memantine can
significantly protect against traumatic brain injury by inhibiting the
activity of NMDA receptors (2), i.e. it acts as an antagonist.
Memantine and Excitotoxins
Biochemist James South MA, pointed out that there are daily factors
in everyday lives, (many of them present in certain diets), that cause
over excitation of NMDA receptors. Most notably these are some artificial
sweeteners, flavor enhancers, (especially MSG) and even hydrolyzed vegetable
As Alzheimer's disease, vascular and mixed dementia are the commonest
forms of dementia in older people, the question is being asked in some
circles; Are they nothing more than the result of a long term exposure
to a bad diet? A diet, that leads to over stimulation of NMDA receptors?
We don't know the answer yet, but we do know enough to take some simple
steps to try and avoid some of the issues.
James South went further to say that you will discover why and how certain
substances can cause this damage. He also goes on to recommend particular
regimes that can help protect against excitotoxins, including Memantine.
He also pointed out that learning about, and doing what is necessary
to cope with, the brain's tendency to excitotoxically melt down, is the
best brain anti-aging insurance available.
Memantine: Alzheimer Clinical Studies
There have been numerous clinical studies with Memantine and
Alzheimer's disease. One clinical study, (4) conducted under the proper
double-blind placebo-controlled method, concluded that Memantine is a
safe drug and may be useful for treating Alzheimer's disease, vascular
and mixed dementia of all severities.
Even in elderly patients with general cognitive disturbances, (but not
yet diagnosed as a specific senile dementia), Memantine has been shown
to enhance vigilance and improve short-term memory and concentration.
Furthermore, the tolerance of the drug was good in virtually all cases
After 28-weeks of treatment, a French study with 321 Geriatric patients
in 2002 concluded that; "Patients with mild to moderate dementia
had improved cognition consistently at 20mg/day Memantine, with no deterioration
in functioning and behavior." Furthermore, the study stated that;
"Memantine was devoid of concerning side effects." (9)
The beneficial effects of Memantine can be seen quickly. For example,
a study with 66 patients aged 65 to 80 and all suffering from mild to
moderate dementia (10), indicated that after just 14-days there was significant
improvement when compared to placebo. At 42-days the effects were even
more pronounced and the study announced that; It was particularly
striking in the daily-living tests, of the patients considerable improvement
achieved in the quality of performing tasks under Memantine treatment.
Perhaps most interesting of all has been the reports of Memantine's efficacy
in late-stage Alzheimer's disease. This distressing phase of the disease
is one where other treatments are not currently available. For example,
a Swedish study in 1999 confirmed that; The results of the trial support
that Memantine treatment leads to functional improvement and reduces care
dependence in severely demented patients. (12)
A more recent study with 252 patients studied over a period of 28-weeks,
(11) receiving either placebo or 20mg/day of Memantine; it was clearly
noted that Memantine reduced the clinical deterioration in moderate to
severe Alzheimer's disease. Dr. Hans Joerg Moebius stated that; These
promising results represent a breakthrough in terms of significant patient
and caregiver benefit by Memantine, in the untapped therapeutic area of
advanced dementia. In addition, compared to other anti-dementia drugs,
Memantine showed an excellent safety and tolerability profile.
Memantine: Many Other Uses?
However, as is quite usual with most other drugs, there may be
numerous other beneficial uses for Memantine. For example, studies indicate
that it could be effective for Parkinson's disease. One such clinical
study, (6) concluded with the statement; The results suggest that
Memantine may improve Parkinsonian symptoms independently of dopaminergic
What's more, further studies suggest that Memantine and NMDA receptors
may have a role in alcoholism and that Memantine could act as an anti-craving
drug for alcohol (7). There are also reports that Memantine could be efficacious
in the alleviation of some intense pain conditions, particularly for painful
neuropathy, with one trial at 40mg/day Memantine, statistically and significantly
alleviating night time pain for patients, when compared to placebo (13).
There are even on-going trials utilizing Memantine for glaucoma and ocular
hypertension, as well as AIDS related dementia (14).
Whilst further research is needed in these areas, it is becoming apparent
that NMDA receptors have a number of negative effects when they are over-stimulated,
and that antagonists such as Memantine, are going to become important
factors in the management and control of numerous debilitating conditions.
- Wenk GL, Quack G, Moebius HJ, Danysz W. "No
interaction of memantine with acetylcholinesterase inhibitors approved
for clinical use." Life Sci. 2000 Feb. 11;66(12):1079-83.
- Roa VL, Dogan A, Todd KG, Bowen KK, Dempsey
RJ. "Neuroprotection by memantine, a non-competitive NMDA receptor
antagonist after traumatic brain injury in rats." Brain res. 2001
- Lipton S. Rosenberg, P. "Excitatory amino
acids as a final common pathway for neurologic disorders" NEJM
1994, 330: 613-22.
- Areosa SA, Sherriff F. "Memantine for dementia."
Syst. Rev. 2003; (1):CD003154.
- Jain KK. "Evaluation of Memantine for neuroprotection
in dementia." Expert. Opin. Investig. Drugs 2000 Jun:9(6):1397-406.
- Merello M, Nouzeilles MI, Cammarota A, Leiguarda
R. "Effect of Memantine on Parkinson's disease: A double-blind
crossover randomized study." Clin. Neuropharmacol. 1999 Sep-Oct;22(5):273-6.
- Holter SM, Danysz W, Spanagel R. "Evidence
for alcohol anti-craving properties of Memantine." Eur. J. Pharmacol.
1996 Oct. 31;314(3):R1-2.
- Ambrozi L, Danielczyk W. "Treatment of impaired
cerebral function in Psychogeriatric patients with Memantine: Results
of a phase II double-blind study." Pharmacopsychiatry 1988 May;21(3):144-6.
- Orgogozo JM, Rigaud AS, Stoffler A, Mobius HJ,
Forette F. "Efficacy and safety of Memantine in patients with mild
to moderate vascular dementia." Stroke 2002 Jul;33(7):1834-9.
- Ditzler K. "Efficacy and tolerability of
Memantine in patients with dementia syndrome. A double blind placebo
controlled trial." Arneimittelforschung 1991 Aug;41(8):773-80.
- Reiseberg B, Doody R, Stoffler A, Schmitt F,
Ferris S, Mobius HJ. "Memantine in moderate to severe Alzheimer's
disease." N. Engl. J. Med. 2003 Apr. 3;348(14):1333-41.
- Winblad B, Poritis N. "Memantine in severe
dementia: The benefit and efficacy in severely demented patients during
treatment with Memantine." Int. J. Geriatr. Psychiatry 1999 Feb;14(2):135-46.
- Results from the 52nd Annual Meeting of the American
Academy of Neurology in San Diego, April 29 to May 6, 2000.
- Kilpatrick GJ, Tilbrook GS. "Abstract."
Curr. Opin. Investig. Drugs 2002 May;3(5):798-806.
/ Memantin Hydrochloride
The active ingredient is memantin hydrochloride.
Other ingredients contained in the tablet are: lactose
monohydrate, microcristalline cellulose, colloidal silicium dioxide, talc
and magnesium stearate; and in the coating are: methacryl acid - ethyl
acrylate copolymer (1:1), sodium dodecyl sulphate, polysorbate 80, talc,
triacetin and simethicone emulsion.
What is AXURA and what are the indications
for its Use? What is AXURA?
AXURA tablets are white to shaded white long coated tablets with
notches on both top and bottom.
Each tablet contains 10 mgs of memantin hydrochloride.
AXURA tablets are available in blister packages
of 50 or 100 tablets.
What are indications for the use of AXURA?
AXURA is to be used for treating patients with moderately severe
to severe Alzheimer's disease.
Memory loss associated with Alzheimer's is caused by a disruption in the
transmission of brain signals. So-called NMDA receptors in the brain assist
in transmission of nerve signals essential to learning and memory functions.
AXURA belongs to a group of medications called NMDA receptor antagonists.
AXURA stimulates these NMDA receptors and improves transmission of nerve
signals and thereby the memory.
What should you consider before taking AXURA?
Prior to taking AXURA, it is important that you carefully read
the following paragraphs and discuss any questions you may have with your
doctor. You may wish to go through all the details you would like to discuss
first with your carer.
AXURA must not be taken:
If you have had allergic reactions to memantin hydrochloride
or any of the other ingredients of AXURA tablets listed above.
Particular caution is required when taking
If you have a history of epileptic seizures
If you have recently suffered a myocardial infarction (heart attack) or
if you suffer from under-compensated cardiac insufficiency or untreated
high blood pressure.
Under these circumstances treatment must be carefully monitored and the
clinical use of AXURA regularly re-evaluated by your doctor.
If you suffer from moderately severe kidney dysfunction, your doctor should
carefully monitor your kidney function and adapt the memantin dosage appropriately.
The use of memantin is not recommended for patients with severe kidney
Simultaneous use of medications with active ingredients such as amantadine,
ketamine, dextromethorphane as well as other NMDA antagonists should be
The use of AXURA is not recommended for children or anyone under the age
Taking AXURA with food and drink
Please inform your doctor if you have recently undergone major
dietary changes (for example from a normal diet to a strictly vegetarian
diet) or if you intend to do so, if you suffer from renal tubular acidosis
(RTA - an excess of acid forming substances in the blood due to kidney
dysfunction) or a severe infection of the urinary tract. Your doctor may
need to adjust the dosage of your medication in such circumstances.
Tell your doctor if you are pregnant or wish to become pregnant.
The use of memantin is not recommended during pregnancy.
Women must not breast-feed while taking AXURA.
Operating vehicles or machinery:
Your doctor will advise you whether your condition allows you
to drive or operate machinery without danger to yourself or others.
Moreover, taking AXURA may alter your reaction time
significantly, so that safe driving and safe operation of machinery may
no longer be possible.
Interaction with other medications
Please inform your doctor or pharmacist if you are taking other
medications or have done so until recently, even if these are not prescription
The following medications specifically may be affected by taking AXURA
and necessitate an adjustment to your dosage by your doctor:
Amantadine, ketamine, dextromethorphane
Cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
Hydrochlorothiazide (or combined preparations containing hydrochlorothiazide)
Anticholinergics (substances normally prescribed to treat motor dysfunction
Anticonvulsives (substances used to prevent or treat cramping)
Barbiturates (substances normally used to induce sleep)
Dopaminergic antagonists (substances such as L-dopa and bromocriptine)
Neuroleptics (substances that treat mental dysfunction)
If you are admitted to hospital, inform the hospital doctor that you are
How should AXURA be taken?
Always follow your doctor's instructions when taking AXURA. You
should take the medication regularly on a daily basis for optimum effect.
Please ask your doctor or pharmacist if you have any doubts.
The recommended AXURA dose for adults and older patients is 20
mgs (2 x 1 tablet) every day. In order to lower the risk of side effects,
this dose should be introduced gradually according to the following daily
|Week 4 and on
The usual starting dose consists of half a tablet (1 x 5mgs) once a day
during the first week. This dose is increased to a half a tablet twice
a day (2 x 5 mgs) in the second week and to one tablet (1 x 10mgs) and
a half tablet (1 x 5mgs) daily at different times during the third week.
Starting in the fourth week the normal dose will be one tablet twice a
day (2 x 10mgs).
Dosage for patients with decreased kidney function
If you suffer from kidney dysfunction, your doctor must decide what dosage
is appropriate for your disease. In this case, kidney function should
be monitored by your doctor at regular intervals.
Instructions for use
AXURA should be taken orally twice a day (except for the first week of
treatment). Tablets should be swallowed with water. The tablets may be
taken with or without food.
Duration of treatment
Continue taking AXURA as long as the medication helps and you are not
experiencing any unacceptable side effects. Treatment should be regularly
assessed by a doctor.
If you have taken a larger dose of AXURA
In general, taking more AXURA than prescribed should not have
any adverse effects. It is possible that you may experience a more severe
form of the symptoms detailed in paragraph 4 - "What are the potential
If you have taken a large overdose of AXURA, consult your doctor or seek
other medical advice, as you may require medical treatment.
If you have forgotten to take AXURA:
If you realize that you have forgotten to take your dose of AXURA,
wait and take your next dose at the usual time.
Do not double your dose to compensate for the missed dose.
What are the potential side effects?
As with all medications, AXURA can produce side effects.
In general, side effects have been observed to be weak or only moderately
severe. Most frequent side effects (frequency of 2% or less) include hallucinations,
confusion, dizziness, headache and fatigue. Occasional side effects include
anxiety, hyper tonus (heightened muscle tension), vomiting, bladder infections
and increased sexual drive.
If you have a history of epileptic seizures, there is a slight chance
that AXURA may increase the probability of an attack.
Please inform your doctor or pharmacist should you experience side effects
not included in this pamphlet.
How should AXURA be stored?
Keep medications out of the reach of children.
There are no specific storage instructions applicable to this medication.
Do not use this medication after the expiration date shown on the box
and the blister package.