RISTOR Oral Solution 1mgml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RISPERIDONE

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

RISPERIDONE

Unit dalam pakej:

30 ml

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
RISTOR ORAL SOLUTION 1MG/ML
Risperidone (1mg per ml)
1
WHAT IS IN THIS LEAFLET
1.
What RISTOR is used for
2.
How RISTOR works
3.
Before you use RISTOR
4.
How to use RISTOR
5.
While you are using RISTOR
6.
Side effects
7.
Storage and disposal
8.
Product description
9.
Manufactured by and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT RISTOR IS USED FOR
RISTOR
is
used
to
treat
a
group
of
disorders
called
psychoses
(e.g.
schizophrenia). These are brain function
disorders
relating
to
thought,
feeling
and/or
action,
such
as
confusion,
impaired
perception
(like
hearing
the
voice
of
someone
who
is
not
there),
unusual suspiciousness, alienation from
society,
and
being
excessively
introverted,
as
well
as
the
resulting
disturbed
mental
state,
anxiety,
and
tension.
RISTOR may be taken for both sudden
(acute)
and
long-lasting
(chronic)
psychotic disorders.
In addition, after symptoms have been
relieved, RISTOR is used to keep the
disorder under control, i.e. to prevent its
recurrence.
RISTOR is indicated for the treatment of
moderate
to
severe
manic
episodes
associated with bipolar disorders.
RISTOR
is
used
to
treat
short-term
treatment (up to 6 weeks) of long-term
aggression
in
intellectually
disabled
children (at least 5 years of age) and
adolescents with conduct disorder.
HOW RISTOR WORKS
Acts
in
the
central
nervous
system,
RISTOR
works
on
the
balance
of
chemical substances which act on the
nervous system in the brain.
BEFORE YOU USE RISTOR
_-When you must not use it _
Do not take RISTOR if you are allergic
to
risperidone
or
any
of
the
other
ingredients of this medicine.
_-Pregnancy and breastfeeding _
Tell your doctor or pharmacist if you are
pregnant, planning to get pregnant or are
breastfeeding.
Risperidone should not be used during
pregnancy unless clearly necessary.
The
following
symptoms
may
occur
in
newborn babies, of mothers that have
used Risperidone in the last trimester
(last three months of their pregnancy):
shaking,
muscle
stiffn

Ciri produk

RISTOR ORAL SOLUTION 1MG/ML
COMPOSITION AND STRENGTH OF ACTIVE INGREDIENTS:
Each ml contains:
Risperidone ………………………..…….1mg
Preservative:
Benzoic acid………………………………0.20% w/v
PRODUCT DESCRIPTION
A clear colourless liquid.
PHARMACODYNAMICS
Risperidone is a selective monoaminergic antagonist with unique
properties. It has a high
affinity for serotonergic 5-HT2 receptors and dopaminergic D2
receptors. Risperidone binds
also to alpha1-adrenergic receptors, and, with lower affinity, to
H1-histaminergic and alpha2-
adrenergic
receptors.
Risperidone
has
no
affinity
for
cholinergic
receptors.
Although
risperidone is a potent D2 antagonist, which is considered to improve
the positive symptoms
of schizophrenia, it causes less depression of motor activity and
induction of catalepsy than
classical antipsychotics. Balanced central serotonin and dopamine
antagonism may reduce
extrapyramidal side effect liability and extend the therapeutic
activity to the negative and
affective symptoms of schizophrenia.
PHARMACOKINETICS
Risperidone oral solution is bioequivalent to risperidone film-coated
tablets.
Risperidone is metabolised to 9-hydroxy-risperidone, which has a
similar pharmacological
activity to risperidone (see Biotransformation and Elimination).
Absorption
Risperidone
is
completely
absorbed
after
oral
administration,
reaching
peak
plasma
concentrations within 1 to 2 hours. The absolute oral bioavailability
of risperidone is 70%
(CV=25%). The relative oral bioavailability of risperidone from a
tablet is 94% (CV=10%)
compared with a solution. The absorption is not affected by food and
thus risperidone can be
given with or without meals. Steady-state of risperidone is reached
within 1 day in most
patients. Steady-state of 9-hydroxyrisperidone is reached within 4-5
days of dosing.
Distribution
Risperidone is rapidly distributed. The volume of distribution is 1-2
l/kg. In plasma, risperidone
is bound to albumin and alpha1-acid glycoprotein. The plasma protein
binding of risperidone
is 9