Apalife 10mg Tablet

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

ARIPIPRAZOLE

Disponibil de la:

MEDISPEC (M) SDN.BHD

INN (nume internaţional):

ARIPIPRAZOLE

Unități în pachet:

30tablet Tablets

Produs de:

UNISON LABORATORIES CO.LTD

Prospect

APALIFE 10MG TABLET
APALIFE 15MG TABLET
Aripiprazole (10mg, 15mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Apalife_
is used for
2.
How
_Apalife_
works
3.
Before you use
_Apalife_
4.
How to use
_Apalife_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
_Apalife_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _APALIFE_ IS USED FOR
Treatment of acute episodes of
schizophrenia and for maintenance of
clinical improvement during continuation
therapy. Aripiprazole is indicated for the
treatment of acute manic episodes
associated with Bipolar I Disorder.
HOW _APALIFE_ WORKS
_Apalife _
(Aripiprazole) is an antipsychotic
medication. It works by changing the
actions of chemicals in the brain.
BEFORE YOU USE _APALIFE_
-
_When you must not use it _
If you are allergic to Aripiprazole or any
of the other ingredients of
_Apalife_
.
_ _
_ _
_Pregnancy and lactation _
Do not take
_Apalife_
if you are pregnant,
trying to get pregnant or think you may
be pregnant.
Do not take
_Apalife_
if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
-
_Before you start to use it _
Talk to your doctor before taking
_Apalife _
if you suffer from:
_ _

High blood sugar or family history
of diabetes

Seizures

Involuntary, irregular muscle
movements, especially in the face.

Heart disease, family history of
heart disease, stroke or “mini”
stroke, abnormal blood pressure

You have ADHD (Attention Deficit
Hyperactivity Disorder)

You are under 18 years old.

You have lactose intolerance.

You are an elderly suffering from
dementia (loss of memory)

You have a history of excessive
gambling or other unusual urges
(eg. increased sexual urges, binge
or compulsive eating, and
compulsive shopping)
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supermarket or health f

Caracteristicilor produsului

APALIFE TABLET
ANTIPSYCHOTIC
Each film coated tablet contains:
ARIPIPRAZOLE 10 MG
ARIPIPRAZOLE 15 MG ♦ PRODUCT DESCRIPTION:
_10 MG: _
Pink, modified rectangle, biconvex, film coated tablet with engraved
10 on one side and plain on the other
_15 MG: _
Yellow, round, biconvex, film coated tablet with engraved 15 on one
side and plain on the other ♦ MECHANISM OF ACTION:
_PHARMACOLOGY _
It has been proposed that Aripiprazole's efficacy in schizophrenia and
Bipolar I Disorder is mediated through a combination of partial
agonism at dopamine D2 and serotonin 5HT1a
receptors and antagonism of serotonin 5HT2a receptors. Aripiprazole
exhibited antagonist properties in animal models of dopaminergic
hyperactivity and agonist properties in animal
models of dopaminergic hypoactivity. Aripiprazole exhibited high
binding affinity
_in vitro_
for dopamine D2 and D3, serotonin 5HT1a and 5HT2a receptors and
moderate affinity for
dopamine D4, serotonin 5HT2c and 5HT7, alpha-1 adrenergic and
histamine H1 receptors. Aripiprazole also exhibited moderate binding
affinity for the serotonin reuptake site and no
appreciable affinity for muscarinic receptors. Interaction with
receptors other than dopamine and serotonin subtypes may explain some
of the other clinical effects of Aripiprazole.
_PHARMACOKINETICS _
Absorption
Aripiprazole is well absorbed, with peak plasma concentrations
occurring within 3-5 hours after dosing. Aripiprazole undergoes
minimal pre-systemic metabolism. The absolute oral
bioavailability of the tablet formulation is 87%. There is no effect
of a high fat meal on the pharmacokinetics of Aripiprazole.
Distribution
Aripiprazole is widely distributed throughout the body with an
apparent volume of distribution of 4.9 l/kg, indicating extensive
extravascular distribution. At therapeutic concentrations,
Aripiprazole and dehydro-Aripiprazole are greater than 99% bound to
serum proteins, binding primarily to albumin.
Biotransformation
Aripiprazole is extensively metabolized by the liver primarily by
three biotransformation