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Ebixa® (also
known as memantine hydrochloride)
The purpose of this medication
Ebixa
has been conditionally approved* by
Health Canada to relieve the symptoms of people with
moderate to advanced Alzheimer's disease. It has been approved
pending the results of further studies to verify its
clinical benefit.
Ebixa is one of a group of drugs called NMDA (N-methyl-D-aspartate) receptor antagonists. Receptors are
molecules on cells which "receive" other molecules, so allowing those molecules to initiate important chemical
reactions. The NMDA receptors are the receiving targets of glutamate molecules released from nerves; when
these molecules interact with NMDA receptors they function as "neurotransmitters", passing on messages
from one nerve cell to another. In a disease like Alzheimer's disease, nerve cells get sick and then massive
amounts of glutamate leak out of them. This excess of glutamate leads to excessive interaction with the NMDA
receptors. The consequence is a toxic one; the "receiving" nerve cells get sick and may die. Ebixa and other
Memantine-like drugs work by themselves interacting with the NMDA receptors, but all they do is block
them and prevent glutamate from interacting with them, thereby reducing the toxicity of excess glutamate. The
result is a normalization of the transmission of nerve messages between nerve cells, and a slowing in the
decline of memory and cognition in Alzheimer's disease.
Ebixa can be used on its own or in combination with cholinesterase inhibitors (i.e., Aricept, Exelon, or
ReminylER). Ongoing research is finding that combining cholinesterase inhibitors together with Ebixa seems
to greatly improve outcomes, sometimes more than predicted from the sum of the effects of either drug alone.
However, more and larger drug trials are needed to confirm these promising early results.
In controlled clinical trials, Ebixa has been used on its own and in combination with Aricept.
How does it help?
Ebixa is intended to treat symptoms in people with moderate to advanced Alzheimer's disease. In clinical
trials, individuals who took the drug when compared to individuals who took a placebo (a substance which
looks like the drug but has no effect), showed stabilization or slower decline in cognition (including memory,
orientation, language) and function (including performance of daily activities).
The medication may take as long as 12 weeks to begin working and the type and length of response as well as
the time it takes for patients to respond to this medication will vary from person to person.
Will this medication cure Alzheimer's disease?
Ebixa is not a cure for Alzheimer's disease as it does not affect the underlying degenerative process of the disease.
Who should take this medication?
The medication is for people who have been diagnosed with moderate to advanced Alzheimer's disease.
How do you obtain this medication?
Ebixa can only be obtained with a prescription from a doctor after a diagnosis of Alzheimer's disease has been made.
A reminder: This medication has been prescribed only for you or for the person you are caring for. It must not be given to anybody else or used for any other illness.
Important! Things to know before taking this medication
Before taking Ebixa, give the doctor the following information:
- all medical conditions, including heart problems, uncontrolled hypertension (high blood pressure),
history of seizures or kidney disease
- any medications, including prescriptions and non-prescriptions which you are currently taking or have
taken within the last 14 days
- if you ever had an allergic reaction to any medication
- if you have a urinary tract infection, kidney problems, or if you have recently changed your diet
substantially (e.g., from a diet including meat to a vegetarian diet)
How do you take this medication?
- Take the medication only as instructed by the doctor.
- Usually the doctor will prescribe 20 mg per day, which
can be taken as two separate doses of 10 mg.
- To
reduce the risk of undesirable reactions, the 20 mg
dose will be achieved gradually, depending on the person’s
response and tolerability.
- The minimum recommended interval between increasing
the dose is one week, as shown in the following table:
| 10
mg tablet |
Morning |
Afternoon |
| Week
1 |
½ tablet |
None |
| Week
2 |
½ tablet |
½ tablet |
| Week
3 |
1
tablet |
½ tablet |
| Week
4 and beyond |
1
tablet |
1
tablet |
- Do not change the dose of the medication, unless the doctor instructs you to do so.
- The medication can be taken with or without food.
- Swallow the tablets whole, with some water.Do not chew tablets.
- Stop taking the medication and contact the doctor immediately if you experience an allergic reaction or
any severe reaction.
- Continue to take the medication as long as directed by the doctor and you do not experience any
unacceptable reactions. The doctor should monitor and assess the treatment regularly.
- If you miss a dose, do not take the missed tablet, but take the next dose when it is due.
What are the possible side effects?
Along with its beneficial effect, Ebixa may cause some undesirable reactions. These may include fatigue,
dizziness, sleepiness, headache, hypertension (high blood pressure), constipation, vomiting, anxiety, confusion, hallucinations and sleep disturbance. If you develop any other side effects while taking this medication, consult
the doctor. If you suffer from epileptic seizures, there is a slight possibility that the medication may increase
the chances of one occurring.Also, as this product may cause sleepiness or dizziness, do not drive or operate
machinery under these conditions.
What
to do if an overdose is taken
If more medication has been taken than what is prescribed, contact either your doctor, hospital emergency department, or the nearest poison control centre immediately, even if you do not feel sick.
How do you store this medication?
Ebixa
tablets contain memantine hydrochloride. The 10 mg tablets
are white to off-white.
- Keep this medication in a safe place, out of the reach
of children.
- Store
the tablets at room temperature (15°-30° C)
and in a dry place.
- If the doctor tells you to stop taking the medication,
return any leftover tablets to the pharmacist, unless
the doctor tells you to keep them.
How much does the medication cost?
The medication costs approximately $5.00 per day. Currently, it is only covered under the provincial drug plan in the Province of Quebec. Some private insurance plans may cover the medication.
Who distributes this medication?
Lundbeck
Canada Inc. is the distributor of this medication. You
can contact the company's
medical information line at 1-866-880-4636 for more information.
For
further information
This
information sheet is a brief description about this medication.
For further information or advice, please contact your
doctor or pharmacist.
*For conditions that are life-threatening or cause severe impairment (such as Alzheimer's disease), the Health Products and Food Branch (HPFB), Health Canada, can authorize a drug manufacturer to market a drug with the condition that the drug manufacturer undertake additional studies to verify the drug's benefit. The authorization is a Notice of Compliance with condition (NOC/c). A NOC/c is given to an eligible drug which has demonstrated promising clinical effectiveness in clinical trials. The product must be of high quality and possess an acceptable benefit. The conditions include a requirement to closely monitor the drug for adverse reactions and to provide HPFB with regular updates. Once the conditions are met, the designation is removed.
For
more information on how drugs are approved in Canada,
see
the Alzheimer Society of Canada's information sheet
on Clinical Drug Trials and Research Studies available
from your local Alzheimer
Society or visit
this page.
Alzheimer
Society of Canada Statement on the Conditional Approval
of Ebixa®
Dec. 13, 2004
[The
contents of this document are provided for information purposes
only, and do not represent advice, an endorsement or a recommendation,
with respect to any product, service or enterprise, and/or
the claims and properties thereof, by the Alzheimer Society
of Canada.]
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