TORQUITE SR 200 MG TABLETS

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

QUETIAPINE FUMARATE

Tersedia dari:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN (Nama Internasional):

QUETIAPINE FUMARATE

Unit dalam paket:

10tablet Tablets; 60tablet Tablets

Diproduksi oleh:

TORRENT PHARMACEUTICALS LTD

Selebaran informasi

TORQUITE SR TABLETS
_ _
Quetiapine Fumarate 200mg
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Torquite SR used for
2.
How Torquite SR works
3.
Before you use Torquite SR
4.
How to use Torquite SR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Torquite
SR
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TORQUITE SR IS USED FOR
Torquite SR contains a medicine called
quetiapine.
Torquite
SR
can
be
used
to
treat
conditions such as:
•
Schizophrenia:
where
you
may
hear
or
feel
things
that
are
not
there, believe things that are not
true or feel unusually suspicious,
anxious, confused, guilty, tense or
depressed.
•
Mania: where you may feel very
excited,
elated,
agitated,
enthusiastic or hyperactive or have
poor
judgment
including
being
aggressive or disruptive.
•
Bipolar depression: where you may
feel sad all the time or you may
find that you feel depressed, feel
guilty,
lack
energy,
lose
your
appetite or can’t sleep.
When Torquite SR is is being taken to
treat
major
depressive
episodes
in
major
depressive
disorder,
it
will
be
taken in addition to another drug being
used to treat this illness.
Your doctor may continue to prescribe
Torquite SR even when you are feeling
better.
HOW TORQUITE SR WORKS
Torquite SR contains a medicine called
quetiapine. This belongs to a group of
medicines called antipsychotics.
Torquite SR helps to correct chemical
imbalances in the brain.
BEFORE YOU USE TORQUITE SR
-
_When you must not use it _
•
If you are allergic (hypersensitive)
to quetiapine or any of the other
ingredients of Torquite SR.
•
If
you
are
taking
any
of
the
following medicines:
-
Protease
inhibitors,
such
as
nelfinavir (for HIV infection).
-
Azole
medicines
(for
fungal
infections).
-
Medicines
for
an
infection
(like
erythromycin
or
clarithromycin).
-
Nefazodone (for depression).
Do not take Torquite SR if the above
applies to you. If you are not sure, talk
to
your
doctor
or
pharmacist
before

Karakteristik produk

Proposed Prescribing Information
For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory
TORQUITE SR 200 MG TABLETS
QUETIAPINE FUMARATE SUSTAINED RELEASE TABLETS 200MG
BRAND OR PRODUCT NAME
TORQUITE SR 200 MG TABLETS
NAME AND STRENGTH OF ACTIVE S UBSTANCE(S)
TORQUITE SR 200 MG TABLETS
Each film coated sustained release tablet contains:
Quetiapine Fumarate equivalent to Quetiapine ………200mg
Colors: Titanium Dioxide and Yellow oxide of Iron
PRODUCT DESCRIPTION
TORQUITE SR 200 MG TABLETS
Yellow coloured, capsule shaped biconvex film coated tablets, printed
with '243'.
DOSAGE FORM
Film coated sustained release tablet
PHARMACODYNAMICS
Pharmacotherapeutic group: Antipsychotics
ATC code: N05A H04
Mechanism of action:
Quetiapine is an atypical antipsychotic agent. Quetiapine and the
active human plasma
metabolite, norquetiapine interact with a broad range of
neurotransmitter
receptors. Quetiapine and norquetiapine exhibit affinity for brain
serotonin (5HT
2
) and
dopamine D
1
- and D
2
-receptors. It is this combination of receptor antagonism with a
higher selectivity for 5HT
2
relative to D
2
-receptors, which is believed to contribute to
the clinical antipsychotic properties and low extrapyramidal side
effect (EPS) liability of
quetiapine
compared
to
typical
antipsychotics.
Additionally,
norquetiapine
has
high
affinity at serotonin 5HT
1
receptors. Quetiapine and norquetiapine also have high affinity
at histaminergic and
adrenergic
α
1
-receptors,
with
a
lower
affinity
at
adrenergic
α
2
-
receptors.
Quetiapine
has
no
appreciable
affinity
at
muscarinic
or
benzodiazepine
receptors. Quetiapine is
active
in tests
for
antipsychotic
activity,
such
as conditioned
avoidance. It also blocks the action of dopamine agonists, measured
either behaviourally
or
electrophysiologically,
and
elevates
dopamine
metabolite
concentrations,
a
neurochemical index of
D
2
-receptor blockade. The
extent to which the
norquetiapine
metabolite contributes to the pharmacological activity of quetiapine
in humans is not
k