Ebixa 10 mg

Generic Name: Memantine 10 mg
Ebixa 10 mg Image

Images for reference only. Packaging will vary.

Ebixa Facts

Ebixa works in the brain to regulate levels of glutamate, which is believed to help improve memory and function in Alzheimer's patients.

Ebixa is available in Canada and the U.K., and is marketed in the U.S. as Namenda and in Germany as Axura.

In 2008, global sales of Ebixa, Namenda and Axura exceeded $6 billion.

Ebixa is marketed by Copenhagen-based Lundbeck A/S, while its U.S. counterpart, Namenda, is marketed by Forest Laboratories.


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Ebixa General Information

Ebixa is the name brand for Memantine Hydrochloride. Ebixa is not currently marketed in the US but is used in other countries as a new Alzheimer's Drug. Ebixa is used to treat Alzheimers patients that are in the moderate to severe stage of the disease process. Ebixa is well absorbed in the digestive tract reaching maximum absorption within three to seven hours. There is little metabolism of the drug with 57% to 87% excreted in the urine and remainder eliminated as metabolites that contain little activity.

How Does Ebixa work and what does it do?

Ebixa works by targeting a chemical in the brain known as glutamate. Glutamate is associated with learning and memorization. When there are excess levels of glutamate in the brain it can cause the nerve receptors to get sick and no longer function properly. This can lead to symptoms of Alzheimers disease. Ebixa works by inhibiting the NMDA (N-methyl-D-aspartate) receptors from connecting with the glutamate molecules thereby decreasing the levels and toxicity.

When/How is Ebixa taken/used/applied?

Ebixa is taken by mouth and usually starts with a low dosage at 5 mg daily. The dose is then increased in 5mg increments to 5mg two times a day and eventually tops out at 10 mg twice daily. The maximum dose is 20mg/day. The minimum recommended interval between dose increases is one week.

Side Effects of Ebixa

As with most drugs there are several types of side effects that effect many body systems. These side effects include headaches, dizziness, nausea, syncope, cardiac failure, hypertension, cataract, conjunctivitis, rash, constipation, vomiting, anemia, decreased weight, back pain, coughing dyspnea, pneumonia, pain, fatigue, hallucination, somnolence, aggressive reaction, ataxia, hypokenesia, vertigo, transient ischemic attack, cerebrovascular accident.

Other Brand Names for Ebixa

Ebixa is marketed in the USA as Namenda.

Safety Information:

Patients should not use Ebixa if they are allergic to memantine. Before using Ebixa, they should alert their doctor if they are allergic to any drugs, or if they have epilepsy or other seizure disorders such as cataracts,liver disease, kidney disease, or a bladder or kidney infection. Patients must alert their physicians if they are taking any medications (prescription or non-prescription) within the last 14 days, especially NMDA-receptor antagonists such as amantedine, or any of the following medications: cimetidine, ranitidine, procainamide, quinidine, quinine, hydrochlorothiazide (or any combination with hydrochlorothiazide), anticholinergics (substances generally used to treat movement disorders such as Parkinson's disease or intestinal cramps), dopaminergic agonists (substances such as L-dopa, bromocriptine), ketamine and dextromethorphan (e.g. cough syrup containing DM).

Ebixa is FDA pregnancy category B. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Ebixa passes into breast milk or if it could harm a nursing baby. Safety and efficacy has not been tested on children. Do not use Ebixa without telling your doctor if you are breast-feeding a baby. All your medical conditions, including heart problems, uncontrolled hypertension, history of seizures convulsions or kidney disease.

Alert your physician if you have changed or intend to change your diet drastically such as going from a normal diet to a vegetarian diet.

Dosage:

Ebixa is taken by mouth and usually starts with a low dosage at 5 mg daily. The dose is then increased in 5mg increments to 5mg two times a day and 10 mg twice daily. The maximum dose is 20mg/day. The minimum recommended interval between dose increases is 1 wk.

Visual Description:

Ebixa is a white oblong pill that comes in a blister pack of 7 pills. The pill is stamped with an FL on the front and the milligram dosage on the back, either a five or a ten.

What You Should Know About Ebixa

Ebixa has been prescribed to you, or to someone in your care, by a doctor to relieve your symptoms of Alzheimer's disease.

The brain contains N-methyl-D-aspartate (NMDA) receptors that are involved in transmitting nerve signals and may be important for learning and memory. Abnormal transmission of nerve signals through NMDA-receptors in the brain may affect memory and other mental functions and contribute to symptoms of Alzheimer's disease. Ebixa belongs to a group of medicines called NMDA-receptor antagonists. The action of Ebixa on NMDA-receptors may help normalize the transmission of nerve signals, which may help slow the decline in some of the symptoms of Alzheimer disease.


What You Should Tell Your Doctor BEFORE Taking Ebixa

  • All your medical conditions, including heart problems, uncontrolled hypertension (high blood pressure), history of seizures or kidney disease.

  • Any medications (prescription or non-prescription) which you are taking or have taken within the last 14 days.

    Drugs that may interact with Ebixa include: NMDA-receptor antagonists (e.g. amantadine), or any of the following medications: cimetidine, ranitidine, procainamide, quinidine, quinine, hydrochlorothiazide (or any combination with hydrochlorothiazide), anticholinergics (substances generally used to treat movement disorders or intestinal cramps), dopaminergic agonists (substances such as L-dopa, bromocriptine), ketamine, dextromethorphan (e.g. cough syrup containing DM) and anticoagulant (blood thinner) medications taken by mouth.

  • If you ever had an allergic reaction to any medication.

  • There are conditions which can change the speed at which the body would normally eliminate the drug product over time and you should tell your doctor, as Ebixa dosage may have to be revised if:

    • You have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet)

    • You are suffering from renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction [kidney problems])

    • You have a urinary tract infection

  • If you are pregnant or thinking of becoming pregnant, or if you are breast-feeding.


When NOT to Use Ebixa

  • You should not be taking Ebixa if you are pregnant, unless in the opinion of the doctor, the expected benefit to the patient markedly outweighs the possible hazards to the fetus.

  • You should not be taking Ebixa if you are breast-feeding.

  • Do not take Ebixa if you are allergic to it, or to any of the components of its formulation (for list of components see the section on “ What Does Ebixa Contain:”).

  • Stop taking Ebixa and contact your doctor immediately if you experience an allergic reaction or any severe side effect.


How to Take Ebixa

  • It is important that you take Ebixa exactly as your doctor has instructed.

  • Usually your doctor will prescribe 20 mg per day, which you will take as two separate doses of 10 mg. In order to reduce the risk of side effects this dose will be achieved gradually by the following daily treatment scheme, starting at a dose of 5 mg per day:

      10 mg Tablets
    AM PM
    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
  • Never change the dose of Ebixa unless your doctor tells you to.

  • Swallow the tablets whole with some water. Do not chew tablets. Ebixa can be taken with or without food.

  • Continue to take Ebixa as long as directed by your doctor and you do not experience any unacceptable side effects. Your doctor should assess your treatment on a regular basis


Missed Dose

  • If you miss a dose, do not worry. Do not take the missed tablet(s)—just take the next dose when it is due.


Side Effects for Ebixa and What to do About Them

Like all medicines, Ebixa can cause side effects, although not everybody gets them.

In general, side effects with Ebixa are mild to moderate. If any of the side effects become severe or if they are troublesome or persistent, talk to your doctor.

Common (affects 1 to 10 users in 100):

  • Headache, sleepiness, constipation, tiredness, confusion, hallucinations (strange visions or sounds), vomiting, dizziness, sleep disturbance, anxiety, and high blood pressure

Uncommon (affects 1 to 10 users in 1000):

  • Fungal infections, abnormal gait (abnormal way of walking), heart failure (persistent chest pain, rapid heart rate, severe shortness of breath, swelling of legs or ankles, increased tiredness, lack of appetite, confusion) and venous blood clotting (pain, swelling, changes in skin color, increased warmth in one leg)

Very Rare (affects less than 1 user in 10 000):

  • Seizures (loss of consciousness with uncontrollable shaking)

Additional side effects that have been reported with Ebixa include: inflammation of the pancreas (severe upper stomach pain, often with nausea and vomiting) and psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation and suicide. These events have also been reported in patients treated with Ebixa.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

  • Your doctor will tell you whether your illness allows you to drive or operate machinery. Also, as this product may cause sleepiness or dizziness, do not drive or operate machinery under these conditions.

  • If you have experienced epileptic seizures, there is a possibility that Ebixa may increase the chances of one occurring.


What To Do in Case of Overdose

  • If you have accidentally taken too much Ebixa contact your regional Poison Control Centre and talk to your doctor immediately, even if you do not feel sick. You may require medical attention. If you go to the doctor or the hospital, take the Ebixa container with you.


What Does Ebixa Contain

Each white to off-white Ebixa tablet contains 10 mg of memantine as the active ingredient. The non-medicinal ingredients in the tablets are: lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, talc, triacetin and simethicone emulsion.


Who Manufactures Ebixa

Ebixa tablets are made by:

H. Lundbeck A/S

Ottiliavej 9

DK-2500 Copenhagen, Denmark.

Product License Holder/Distributor:

Lundbeck Canada Inc.

1000 De La Gauchetière Street West, Suite 500

Montreal, Quebec

H3B 4W5

Canada


Technical Information