MEMANXA memantine hydrochloride 10 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

memantine hydrochloride, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

memantine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 6000; hypromellose; microcrystalline cellulose; titanium dioxide; lactose monohydrate; magnesium stearate

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of the symptoms of moderately severe to severe Alzheimer's disease (see Pharmacodynamic properties and Special warnings and precautions for use).

Product summary:

Visual Identification: White to off-white, oval tablets, embossed with a scoreline on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-11-17

Summary of Product characteristics

MEMANXA- Product Information
Page 1 of 11
Memanxa
PRODUCT INFORMATION
NAME OF THE MEDICINE
Memantine hydrochloride. The chemical name for memantine hydrochloride
is 1-amino-3,5-
dimethyl-adamantane hydrochloride. Its structural formula is:
C
12
H
21
N.HCl
Molecular weight: 215.77
Cas No.: 4110-52-1
DESCRIPTION
Memantine hydrochloride is a colourless, crystalline substance with a
bitter taste. The solubility of
memantine hydrochloride in water at room temperature is about 3.5%. No
polymorphic forms have
been detected.
Memanxa tablets contain 10 mg of memantine hydrochloride. The tablets
also contain the following
excipients: lactose, microcrystalline cellulose, magnesium stearate,
hypromellose, macrogol 6000
and titanium dioxide. The tablets are gluten free.
PHARMACOLOGY
There is increasing evidence that malfunctioning of glutamatergic
neurotransmission, in particular at
(N-methyl-D -aspartate) NMDA receptors, contributes to both expression
of symptoms and disease
progression in neurodegenerative dementia.
Memantine is a rapid, strongly voltage dependent, uncompetitive NMDA
receptor antagonist.
Prolonged increased levels of glutamate in the brain of demented
patients are sufficient to counter
the voltage dependent block of NMDA receptors by Mg
2+
ions and allow continuous influx of Ca
2+
ions into cells and ultimately neuronal degeneration. Studies suggest
that memantine binds more
effectively than Mg
2+
ions at the NMDA receptor, and thereby effectively blocks this
prolonged influx
of Ca
2+
ions through the NMDA channel while preserving the transient
physiological activation of the
channels by higher concentrations of synaptically released glutamate.
Thus memantine protects
against chronically elevated concentrations of glutamate.
In animal models of disturbances in glutamatergic transmission
memantine has been shown both to
improve learning and to inhibit neurodegeneration at doses achieving
plasma levels similar to those
seen in clinical use. This in turn may explain the effect of memantine
on dementia of the A