Resicalm Solution 1 mgml

País: Malàisia

Idioma: anglès

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

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
14-07-2018

ingredients actius:

RISPERIDONE

Disponible des:

UNIMED SDN BHD

Designació comuna internacional (DCI):

RISPERIDONE

Unidades en paquete:

100 ml; 30 ml

Fabricat per:

M/s. Aurobindo Pharma Limited,

Fitxa tècnica

                                RESICALM
RISPERIDONE TABLET 1MG, 2MG AND 3MG
RISPERIDONE ORAL SOLUTION 1MG/ML
DESCRIPTION AND COMPOSITIONS:
_RISPERIDONE TABLETS 1MG _
White coloured film coated, biconvex, caplets, debossed on one side
with “A” and on the
other side with “51”. Score line between “5’ and “1”. Each
film coated tablet contains
Risperidone 1mg.
_RISPERIDONE TABLETS 2MG _
Light orange coloured film coated, biconvex, caplets, debossed on one
side with “A” and
on
the
other
side
with
“52”.
Score
line
between
“5’
and
“2”.
Each film coated tablet contains Risperidone 2mg.
_RISPERIDONE TABLETS 3MG _
Yellow coloured film coated, biconvex, caplets, debossed on one side
with “A” and on the
other side with “53”. Score line between “5’ and “3”. Each
film coated tablet contains
Risperidone 3mg.
_RESICALM 1 (RISPERIDONE ORAL SOLUTION 1 MG/ ML) _
A clear, colourless liquid
Each ml of Risperidone equivalent to Risperidone
1 mg.
PROPERTIES
_PHARMACODYNAMIC PROPERTIES _
Risperidone is a selective monoaminergic antagonist with unique
properties. It has a high
affinity for serotoninergic 5-HT2 and dopaminergic D2 receptors.
Risperidone binds also to
alpha1 adrenergic receptors, and with lower affinity to H1
histaminergic and alpha2
adrenergic
receptors.
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 neuroleptics.
Balanced central serotonin
and dopamine antagonism may reduce extrapyramidal side effects
liability and extend the
therapeutic activity to the negative and effective symptoms of
schizophrenia.
_PHARMACOKINETIC PROPERTIES _
Risperidone is completely absorbed after oral administration, reaching
peak
plasma concentrations within 1 to 2 hours. The absorption is not
affected by food
and thus risperidone can give with or without meals._ _
Risperidone is metabolized by cytochrome P-450 llD6 to
9-hydroxy-risperidone
which has a similar pharmacological activi
                                
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