Arian 20 mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
05-09-2016
Ciri produk Ciri produk (SPC)
05-09-2016

Bahan aktif:

ARIPIPRAZOLE

Boleh didapati daripada:

UNIMED SDN BHD

INN (Nama Antarabangsa):

ARIPIPRAZOLE

Unit dalam pakej:

100tablet Tablets; 30tablets Tablets

Dikeluarkan oleh:

Indoco Remedies Limited

Risalah maklumat

                                ARIAN TABLETS
Aripiprazole (10mg, 15mg, 20mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
ARIAN
is used for
2.
How
ARIAN
works
3.
Before you use
ARIAN
4.
How to use
ARIAN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
ARIAN
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT ARIAN IS USED FOR
ARIAN is one of a group of medicines
called antipsychotics. It is used to treat
schizophrenia
and
related
manic
disorders in patients who suffer from a
disease characterized by symptoms such
as
hearing,
seeing
or
sensing
things
which
are
not
there,
suspiciousness,
mistaken beliefs, incoherent speech and
behavior and emotional flatness. People
with
this
conditions
may
also
feel
depressed, guilty, anxious or tense.
HOW ARIAN
WORKS
ARIAN
works
by
acting
on
various
receptors
in
the
brain,
particularly
dopamine receptors and serotonin (5HT)
receptors. Dopamine and serotonin are
natural
compounds
called
neurotransmitters,
and
are
involved
in
transmitting
messages
between
brain
cells. Psychotic illness is considered to
be caused by disturbances in the activity
of neurotransmitters (mainly dopamine)
in the brain. Aripiprazole is thought to
work mainly by stabilising the dopamine
activity in the brain.
BEFORE YOU USE ARIAN
-
_When you must not use it _
_ _
DO NOT TAKE ARIAN:
If
you
are
allergic
(hypersensitive)
to
ARIAN or any of the other ingredients of
ARIAN.
_ _
_Pregnancy and lactation _
Pregnancy
Ask your doctor or pharmacist for advice
before taking any medicine.
Be sure to
tell your doctor immediately if you are
pregnant, think you may be pregnant, or
if you are planning to become pregnant.
Breastfeeding
Ask your doctor or pharmacist for advice
before taking any medicine.
If you are taking ARIAN, you should not
breast-feed.
_-Before you start use it _
TELL YOUR DOCTOR IF YOU SUFFER FROM
:

High blood sugar (characterized
by symptoms such as excessive thirst,
passing
of
large
amounts
of
urine,
increase
in
appetite,
feel
                                
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Ciri produk

                                ARIAN 10 MG TABLETS (ARIPIPRAZOLE 10 MG TABLETS)
ARIAN 15 MG TABLETS (ARIPIPRAZOLE 15 MG TABLETS)
ARIAN 20 MG TABLETS (ARIPIPRAZOLE 20 MG TABLETS)
DESCRIPTION AND COMPOSITION:
_ARIAN 10 MG TABLETS: _
White, uncoated, oval shaped beveled edged tablets. Each uncoated
tablet contains 10 mg of
Aripiprazole.
_ARIAN 15 MG TABLETS: _
White, uncoated, round, biconvex, beveled edged tablets. Each uncoated
tablet contains 15 mg of
Aripiprazole.
_ARIAN 20 MG TABLETS: _
White, uncoated, round, biconvex tablets.
Each uncoated tablet contains 20 mg Aripiprazole.
PHARMACODYNAMICS
Aripiprazole is a psychotropic drug intended for the treatment of
schizophrenia and related
manic disorders.
Aripiprazole exhibits high affinity for dopamine D2 and D3, serotonin
5.HT1A and 5.HT2A
receptors, moderate affinity for dopamine D4, serotonin 5.HT2C and
5.HT7, alpha 1.adrenergic
and histamine HI receptors and moderate affinity for the serotonin
reuptake site. Aripiprazole has
no appreciable affinity for cholinergic muscarinic receptors.
The exact mechanism of action of aripiprazole is unknown. However, it
has been proposed that
the efficacy of aripiprazole is medicated through a combination of
partial agonist activity at D2
and 5.HT1A receptors and antagonist activity at 5-HT2A receptors.
PHARMACOKINETICS
Aripiprazole is well absorbed after administration of the tablet, with
peak plasma concentrations
occurring within 3 hours to 5 hours; the absolute oral bioavailability
of the tablet formulation is
87%. ARIAN tablets can be administered with or without food. At
therapeutic concentrations,
Aripiprazole and its major metabolite are greater than 99% bound to
serum proteins, primarily to
albumin. In healthy human volunteers administered 0.5 mg/day to 30
mg/day Aripiprazole for 14
days, there was dose-dependent D2 receptor occupancy indicating brain
penetration of
Aripiprazole in humans.
Aripiprazole is metabolized primarily by three biotrasformation
pathways: dehydrogenation,
hydroxylation, and N-dealkylation. Based on in vitro studies, CYP3A4
a
                                
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