MEMXA 5mg0.5ml ORAL SOLUTION

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

MEMANTINE HYDROCHLORIDE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

MEMANTINE HYDROCHLORIDE

Unit dalam pakej:

1 x 50 ml

Dikeluarkan oleh:

UNISON LABORATORIES CO.LTD

Risalah maklumat

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MEMXA 5MG/0.5ML ORAL SOLUTION
Memantine hydrochloride (5 mg) eq. to Memantine (4.16 mg) 1
WHAT IS IN THIS LEAFLET
1.
What Memxa is used for
2.
How Memxa works
3.
Before you use Memxa
4.
How to use Memxa
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Memxa
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT MEMXA IS USED FOR
Memxa
is
used
for
the
treatment
of
patients
with
moderate
to
severe
Alzheimer’s disease.
HOW MEMXA WORKS
Memantine hydrochloride belongs to a
group
of
medicines
known
as
anti-
dementia medicines.
Memory loss in Alzheimer’s disease is
due
to
the
disturbance
of
message
signals in the brain. The brain contains
N-methyl-D-aspartate
(NMDA)
receptors
that
are
involved
in
transmitting nerve signals important in
learning and memory. Memxa belongs
to a group of medicines called NMDA-
receptor
antagonists.
It
acts
on
these
NMDA-receptors
improving
the
transmission of nerve signals and the
memory.
BEFORE YOU TAKE MEMXA
_- When you must not use it _
If you are allergic to Memantine or any
of the other ingredients of this medicine.
_PREGNANCY AND BREASTFEEDING _
If
you
are
pregnant
or
breastfeeding,
think
you
may
be
pregnant
or
are
planning to have a baby, ask your doctor
or pharmacist for advice before taking
this medicine.
_Pregnancy _
The
use
of
Memantine
in
pregnant
women is not recommended.
_Breastfeeding _
Women
taking
Memxa
should
not
breastfeed.
_- Before you start to use it _
Talk to your doctor or pharmacist before
taking Memxa:
•
if
you
have
a
history
of
epileptic
seizures
•
if
you
have
recently
experienced
a
myocardial infarction (heart attack), or
if you are suffering from congestive
heart failure or from an uncontrolled
hypertension (high blood pressure).
In these situations the treatment should
be carefully supervised, and the clinical
benefit of Memxa reassessed by your
doctor on a regular basis.
If
you
suffer
fro

Ciri produk

MEMXA 5 MG/ 0.5 ML ORAL SOLUTION
ANTI-DEMENTIA
Each 0.5 mL contains:
MEMANTINE HYDROCHLORIDE 5 MG EQ. TO MEMANTINE 4.16 MG
♦ PRODUCT DESCRIPTION:
Colorless to light yellowish solution ♦ MECHANISM OF ACTION:
Pharmacotherapeutic group: Other Anti-dementia drugs, ATC code:
N06DX01
_PHARMACOLOGY _
There is increasing evidence that malfunctioning of glutamatergic
neurotransmission, in particular at NMDA-receptors, contributes to
both expression of symptoms and disease
progression in neurodegenerative dementia.
_ _
Memantine is a voltage-dependent, moderate-affinity uncompetitive
NMDA-receptor antagonist. It modulates the effects of pathologically
elevated tonic levels of glutamate that may
lead to neuronal dysfunction.
_ _
_PHARMACOKINETICS _
Absorption
_ _
Memantine has an absolute bioavailability of approximately 100 %. T
max
is between 3 and 8 hours. There is no indication that food influences
the absorption of Memantine.
_ _
Distribution
_ _
Daily doses of 20 mg lead to steady-state plasma concentrations of
Memantine ranging from 70-150 ng/mL (0.5-1 μmol) with large
interindividual variations. When daily doses of 5-30
mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of
0.52 was calculated. The volume of distribution is around 10 L/kg.
About 45% of Memantine is bound to plasma-
proteins.
_ _
Biotransformation
_ _
In man, about 80% of the circulating Memantine-related material is
present as the parent compound. Main human metabolites are
N-3,5-dimethyl-gludantan, the isomeric mixture of 4-
and 6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl-adamantane. None
of these metabolites exhibit NMDA-antagonistic activity. No cytochrome
P 450 catalyzed metabolism has been
detected
_in vitro._
Orally administered
14
C-memantine, a mean of 84% of the dose was recovered within 20 days,
more than 99% being excreted renally.
Elimination
_ _
Memantine is eliminated in a monoexponential manner with a terminal t
½
of 60-100 hours. In volunteers with normal kidney function, total
clearance (Cl
tot
) amounts to