Aricog Aripiprazole 10 mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ARIPIPRAZOLE

Boleh didapati daripada:

IDAMAN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

ARIPIPRAZOLE

Unit dalam pakej:

28 Tablets; 14 Tablets

Dikeluarkan oleh:

Atlantic Pharma S.A.

Risalah maklumat

ARICOG TABLET
ARIPIPRAZOLE (10mg, 15mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What ARICOG is used for
2.
How ARICOG works
3.
Before you use ARICOG
4.
How to use ARICOG
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ARICOG
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ARICOG
IS USED FOR
ARICOG 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 ARICOG WORKS
ARICOG
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 ARICOG
BEFORE YOU START TO USE IT
Talk to your doctor or pharmacist if you
have:
-
a history of excessive gambling or
other unusual urges (e.g. increased
sexual urges, binge or compulsive
eating, and compulsive shopping).
-
_When you must not use it _
DO NOT TAKE ARICOG:
If
you
are
allergic
(hypersensitive)
to
ARICOG or any of the other ingredients
of ARICOG.
_ _
_ _
_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 ARICOG, you sh

Ciri produk

ARICOG ARIPIPRAZOLE 10 MG TABLET
ARICOG ARIPIPRAZOLE 15 MG TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Aricog 10 mg tablets
Each tablet contains 10 mg of aripiprazole.
Excipient:
64.98 mg of lactose monohydrate per tablet
Aricog 15 mg tablets
Each tablet contains 15 mg of aripiprazole.
Excipient:
97.47 mg of lactose monohydrate per tablet
PRODUCT DESCRIPTION
Aricog 10 mg tablets
Elliptic, shallow and convex pink tablets.
Aricog 15 mg tablets
Round, shallow and convex yellow tablets.
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%. Aricog 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
and CYP2D6 enzymes
are responsible for dehydrogenation and hydr