Risnia Tablets 2 mg

Country: Malaysia

Language: English

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

Active ingredient:

RISPERIDONE

Available from:

CIPLA MALAYSIA SDN BHD

INN (International Name):

RISPERIDONE

Units in package:

100Tablet Tablets

Manufactured by:

CIPLA LTD

Patient Information leaflet

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undertaking letter(1).pdf was not found on this server.

Summary of Product characteristics

_ _
FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A
LABORATORY ONLY
RISNIA 2 mg Tablets
Risperidone tablets 2 mg
COMPISITION
Each film coated tablet contains:
Risperidone Ph .Eur………………………………………… 2
mg
Colour: Lake Sunset yellow FCF & Titanium Dioxide
DOSAGE FORM
Oral Tablets
DESCRIPTION
Orange coloured, circular, biconvex film coated tablets, plain on both
the sides.
CAUTION: THIS PREPARATION MAY BE HABIT FORMING ON PROLONGED USE
PHARMACOLOGY
PHARMACODYNAMICS
Risperidone is a novel antipsychotic belonging to a new class of
antipsychotic agents,
the benzisoxazole-derivatives.
Risperidone is a selective monoaminergic antagonist with a high
affinity for both
serotonergic 5-HT
2
and dopaminergic D
2
receptors. Risperidone binds also to alpha
1
-
adrenergic receptors and, with lower affinity, to H
1
-histaminergic and alpha
2
-adrenergic
receptors. Risperidone has no affinity for cholinergic receptors.
Although risperidone is a
potent
D
2
antagonist,
that
is
considered
to
improve
the
positive
symptoms
of
schizophrenia, it causes less depression of motor activity and
induction of catalepsy than
classical neuroleptics. Balanced central serotonin and dopamine
antagonism may reduce
the tendency to cause extrapyramidal side effects, and extend the
therapeutic activity to
the negative and affective symptoms of schizophrenia.
PHARMACOKINETICS
Risperidone is completely absorbed after oral administration, reaching
peak plasma
concentrations within 1 to 2 hours. Food does not affect the
absorption of risperidone
from the stomach. The effect of food particles in the mouth on
absorption has not been
studied.
The most important route of metabolism of risperidone is hydroxylation
by cytochrome
CYP 2D6 to 9-hydroxy-risperidone which has a similar pharmacological
activity to
risperidone. This hydroxylation is subject to debrisoquine-type
genetic polymorphism but
this does not affect the active antipsychotic fraction since this
consists of risperidone and
its active metabolite 9-hydro