Apo-Quetiapine 100 mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

QUETIAPINE FUMARATE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

QUETIAPINE FUMARATE

Unit dalam pakej:

100 Tablet Tablets

Dikeluarkan oleh:

APOTEX INC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
APO-QUETIAPINE TABLETS
Quetiapine Fumarate (25mg, 100mg, 200mg)
Page 1
WHAT IS IN THIS LEAFLET
1.
What Apo-Quetiapine is used
for
2.
How Apo-Quetiapine works
3.
Before you use Apo-
Quetiapine
4.
How to use Apo-Quetiapine
While you are using it
5.
Side effects
6.
Storage and Disposal of Apo-
Quetiapine
7.
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of revision
WHAT APO-QUETIAPINE IS USED
FOR
APO-QUETIAPINE is a
prescription medication
containing the active ingredient,
quetiapine fumarate. APO-
QUETIAPINE is intended for the
relief of depressive episodes
associated with the bipolar
disorder (an illness marked by
extreme shifts in mood). This
medication can also be used for
the treatment of acute manic
episodes associated with the
bipolar I disorder, and also
schizophrenia.
HOW APO-QUETIAPINE WORKS
APO-QUETIAPINE is an atypical
antipsychotic agent. It works by
maintaining the amount of certain
natural substances in the brain
that are needed to maintain mental
balance.
BEFORE YOU USE APO-QUETIAPINE
_- When you must not use it_
If you are allergic to quetiapine
fumarate, or any ingredients of
this medication.
_- Before you start to use it_
_ _
Before taking APO-
QUETIAPINE your doctor needs
to know:
•
Any other medical condition
that you may have or
previous history including
heart diseases, seizures;
•
Whether you are planning to
get pregnant, are currently
pregnant or are nursing an
infant;
•
If you have neuroleptic
malignant syndrome (a
neurological disorder) with
symptoms such as elevated
body temperature, altered
mental status and muscular
rigidity.
•
If you have severe
neutropenia (an abnormally
low count of neutrophils, a
type of white blood cell)
•
If you are a diabetic patient
-
_Taking other medicines _
Tell your doctor if you are taking
any other prescription or over-the-
counter medication that you are
currently taking, of particular
seizure relief medications, such as
carbamazepine. Other
medications would include

Ciri produk

APO‐QUETIAPINE
QUETIAPINE AS QUETIAPINE FUMARATE TABLETS 25 MG, 100 MG AND 200 MG
PRODUCT DESCRIPTION
25 MG: Peach, round, biconvex, film‐coated tablet. Engraved
“APO” on one
side, “QUE” over “25” on the other side.
100 MG: Yellow, round, biconvex, film‐coated tablet. Engraved
“APO” on one
side, “QUE” over “100” on the other side.
200 MG: White, round, biconvex, film‐coated tablet. Engraved
“APO” on one
side, “QUE” over “200” on the other side.
PHARMACOLOGY
Pharmacodynamics
Quetiapine is an atypical antipsychotic agent. Quetiapine and the
active
human plasma metabolite, N‐desalkyl quetiapine interact with a broad
range
of neurotransmitter receptors. Quetiapine and N‐desalkyl quetiapine
exhibit
affinity
for
brain
serotonin
(5HT
2
)
and
dopamine
D
1
and
D
2
receptors.
Quetiapine exhibits a higher affinity for serotonin (5HT
2
) receptors in the
brain
than
it
does
for
dopamine
D
1
and
D
2
receptors
in
the
brain.
Additionally, N‐desalkyl quetiapine has high affinity for the
norepinephrine
transporter
(NET).
Quetiapine
and
N‐desalkyl
quetiapine
also
have
high
affinity at histaminergic and adrenergic α
1
receptors, with a lower affinity at
adrenergic α
2
and serotonin 5HT
1
A receptors. Quetiapine has no appreciable
affinity at cholinergic 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.
Pharmacokinetics
Quetiapine
is
well
absorbed
and
extensively
metabolised
following
oral
administration. The bioavailability of quetiapine is not significantly
affected
by administration with food. Quetiapine is approximately 83% bound to
plasma
proteins.
Steady‐state
peak
molar
concentrations
of
the
active
metabolite N‐desalkyl quetiapine are 35% of that observed for
quetiapine.
The
elimination
half