RISPERDAL CONSTA 37.5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RISPERIDONE

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

RISPERIDONE

Unit dalam pakej:

1

Dikeluarkan oleh:

CILAG AG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RISPERDAL
® CONSTA
® INJECTION
Risperidone (25mg, 37.5mg, 50mg)
1
WHAT IS IN THIS LEAFLET
1.
What
RISPERDAL
®
CONSTA
®
is
used for
2.
How RISPERDAL
®
CONSTA
®
works
3.
Before
you
use
RISPERDAL
®
CONSTA
®
4.
How to use RISPERDAL
®
CONSTA
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of RISPERDAL
®
CONSTA
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT RISPERDAL
® CONSTA
® IS USED
FOR
RISPERDAL
®
CONSTA
®
is used to treat a
group of disorders called psychoses (e.g.
schizophrenia).
It
is
also
used
to
treat
bipolar
disorder,
formerly
called
manic
depressive illness. Both sets of conditions
are
brain
function
disorders.
Psychosis
includes symptoms like unusual or bizarre
thoughts,
including
suspiciousness,
impaired perception (like hearing a voice of
someone who is not there), confusion, and
being excessively introverted or becoming
alienated from society. The symptoms of
bipolar disorder include changing moods
(depression
and/or
euphoria),
being
excessively
friendly
and
without
inhibitions, extreme changes in motivation
or energy, irritability, aggressiveness, or
actions
including
poor
judgment.
These
symptoms result in disturbed mental state,
anxiety, and tension.
HOW RISPERDAL
® CONSTA
® WORKS
RISPERDAL
®
CONSTA
®
helps to correct
a chemical imbalance associated with these
conditions.
BEFORE
YOU
USE
RISPERDAL
®
CONSTA
®
-
_When you must not use it _
Do not take RISPERDAL
®
CONSTA
®
if
you
know
that
you
are
allergic
(hypersensitive) to Risperidone or other
ingredients listed at the end of this leaflet.
-
_Before you start to use it _
If you have never taken any form of
RISPERDAL
®
, you should begin with
oral
RISPERDAL
®
before
beginning
treatment
with
RISPERDAL
®
CONSTA
®
.
Tell your doctor if:
•
you or someone else in your family has a
history of blood clots. Blood clots in the
lungs can be fatal.
•
you know that you have had low levels
of white blood cells in

Ciri produk

1
PRODUCT NAME
RISPERDAL
®
CONSTA
®
25 mg
RISPERDAL
®
CONSTA
®
37.5 mg
RISPERDAL
®
CONSTA
®
50 mg
DOSAGE FORMS AND STRENGTHS
RISPERDAL
®
CONSTA
®
contains 25 mg, 37.5 mg or 50 mg risperidone.
RISPERDAL
®
CONSTA
®
is
an
extended
release
microspheres
formulation
of
risperdone, composed of risperidone drug substance micro-encapsulated
in polylactide-
co-glycolide, at a concentration of 381 mg risperidone per gram of
microspheres.
Prolonged-release powder and diluent for suspension for injection.
_ _
_Vial with powder. _
White to off-white free flowing powder.
_Pre-filled syringe of diluent for reconstitution. _
Clear, colorless aqueous solution.
For excipients, see
_List of Excipients._
CLINICAL INFORMATION
INDICATIONS
RISPERDAL
®
CONSTA
®
is
indicated
for
the
treatment
of
schizophrenia
and
schizoaffective disorders.
RISPERDAL
®
CONSTA
®
is indicated as monotherapy or as adjunctive therapy to
lithium or valproate for the maintenance treatment of Bipolar I
Disorder.
DOSAGE AND ADMINISTRATION
For risperidone naive patients, it is recommended to establish
tolerability with oral
risperidone prior to initiating treatment with RISPERDAL
®
CONSTA
®
.
Schizophrenia and Schizoaffective Disorders
_DOSAGE - ADULTS (OLDER THAN 18 YEARS OF AGE) _
The recommended dose is 25 mg intramuscular every two weeks. Some
patients may
benefit from a higher doses of 37.5 mg or 50 mg. No additional benefit
was observed
with 75 mg in clinical trials in patients with schizophrenia. Doses
higher than 50 mg
every 2 weeks are not recommended.
Sufficient antipsychotic coverage should be ensured during the
three-week lag period
following
the
first
RISPERDAL
®
CONSTA
®
injection
(see
_Pharmacokinetic _
_Properties_
).
Upward dosage adjustment should not be made more frequently than every
4 weeks.
The effect of this dose adjustment should not be anticipated earlier
than 3 weeks after
the first injection with the higher dose.
Bipolar Disorder
2
The recommended dose for monotherapy or adjunctive therapy to lithium
or valproate
for the