Memantine hydrochloride

What is Memantine hydrochloride?

• Memantine hydrochloride is a N-methyl-D-aspartate (NMDA) receptor antagonist used for the treatment of moderate to severe dementia of the Alzheimer’s type.

Memantine structure

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What are the uses of this medicine?

• Memantine hydrochloride 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 N-methyl-D-aspartate (NMDA) inhibitors.

How does this medicine work?

• 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.
• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients wh0:

• are allergic to memantine or any of the ingredients in NAMENDA tablets

What drug interactions can this medicine cause?

• 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. Hence, memantine should be used with caution under these conditions.
• The combined use of this medicine with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated.

Is this medicine FDA approved?

• Memantine was approved for medical use in the United States in 2003.

How should this medicine be used?

Recommended dosage:

• The recommended starting dose of NAMENDA is 5 mg once daily.
• The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg 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.

Renal Impairment:

• A target dose of 5 mg twice daily is recommended in patients with severe renal impairment.

Hepatic Impairment:

• NAMENDA should be administered with caution to patients with severe hepatic impairment.

NAMENDA XR:

• The recommended starting dose of NAMENDA XR is 7 mg once daily; the dose should be increased in 7 mg increments to the recommended maintenance dose of 28 mg once daily; the minimum recommended interval between dose increases is one week.
• Patients with severe renal impairment: the recommended maintenance dose of NAMENDA XR is 14 mg once daily.

Administration: NAMENDA:

• NAMENDA can be taken with food or without food.
• Do not use any tablets of NAMENDA that are damaged or show signs of tampering.
• 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.

NAMENDA XR:

• NAMENDA XR may be taken with food or without food.
• NAMENDA XR capsules may be opened and sprinkled on applesauce before swallowing, but the contents of the entire capsule should be taken and the dose should not be divided. Except when opened and sprinkled on applesauce, NAMENDA XR capsules must be swallowed whole and never crushed, divided or chewed.
• Do not use any capsules of NAMENDA XR that are damaged or show signs of tampering.
• If you are currently taking another formulation of memantine, talk to your healthcare professional about how to switch to NAMENDA XR.
• If you forget to take one dose of NAMENDA XR, do not double up on the next dose. You should take only the next dose as scheduled.
• If you have forgotten to take NAMENDA XR for several days, you should not take the next dose until you talk to your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 5 mg and 10 mg
• NAMENDA XR is available as an extended-release capsule in the following strengths: 7 mg, 14 mg, 21 mg, 28 mg

This medicine is available in fallowing brand namesː

• NAMENDA ; NAMENDA XR

What side effects can this medication cause?

The most common side effects of NAMENDA XR include:

• headache
• diarrhea
• dizziness

The most common side effects of NAMENDA include:

• dizziness
• headache
• confusion
• constipation

What special precautions should I follow?

• Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine.

What to do in case of emergency/overdose?

Symptoms of overdosage may 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
• weakness

Treatment of overdosage:

• If you take too much NAMENDA, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
• 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.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of NAMENDA XR, NAMENDA in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

NAMENDA tablets:

• Active ingredient: memantine hydrochloride
• Inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate
• Inactive ingredients of tablet film coating: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)

NAMENDA XR:

• Active ingredient: memantine hydrochloride
• Inactive ingredients: sugar spheres, polyvinylpyrrolidone, hypromellose, talc, polyethylene glycol, ethylcellulose, ammonium hydroxide, oleic acid, and medium chain triglycerides

Who manufactures and distributes this medicine?

Made in Ireland

• Distributed by:

Allergan USA, Inc. Madison, NJ 07940 Licensed from Merz Pharmaceuticals GmbH

• NAMENDA® is a registered trademark of Merz Pharma GmbH & Co KGaA
• NAMENDA XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Memantine hydrochloride
• FDA Memantine hydrochloride

Memantine hydrochloride Resources
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