Apo-Olanzapine 5mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

OLANZAPINE

Boleh didapati daripada:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

OLANZAPINE

Unit dalam pakej:

4 x 7'stablet Tablets; 4 x 7'stablet Tablets; 10 x 10'stablet Tablets; 100 Tablets

Dikeluarkan oleh:

APOTEX INC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
APO-OLANZAPINE TABLETS
Olanzapine (5mg, 10mg)
1
WHAT IS IN THIS LEAFLET
1.
What Apo-Olanzapine is used for
2.
How Apo-Olanzapine works
3.
Before you use Apo-Olanzapine
4.
How to use Apo-Olanzapine
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Olanzapine
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-OLANZAPINE
IS USED FOR
Apo-Olanzapine (olanzapine) is
indicated for the treatment and
maintenance of schizophrenia, a
disease with symptoms such as
hearing, seeing or sensing things
which are not there, mistaken beliefs,
unusual suspiciousness, and
becoming withdrawn.
Apo-Olanzapine is also indicated for
the treatment of moderate to severe
manic episodes, a condition with
symptoms of excitement or euphoria.
HOW APO-OLANZAPINE WORKS
Apo-Olanzapine is in a class of
medications called antipsychotics. It
works by changing the activity of
certain natural substances in the
brain.
BEFORE YOU USE APO-OLANZAPINE
-
_When you must not use it _
Do not use this product if you are
allergic to
_ _
Olanzapine or any other
ingredients in this medication. (Refer
to
PRODUCT DESCRIPTION
)
_ _
Certain medical conditions do not
allow the use of Apo-Olanzapine,
such as narrow-angle glaucoma,
Parkinson’s disease, dementia-related
psychosis and/or behavioural
disturbances. Discuss with your
healthcare provider before you start to
take this medication.
_ _
_Pregnancy and lactation _
Do not take Apo-Olanzapine if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Apo-Olanzapine if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
_ _
-
_Before you start to use it _
Before you start to use this
medication, your doctor need to know
if you have any other medication
condition, which includes:
_ _
•
Any medical condition mentioned in
_When you must not use it_
above.
_ _
•
Any known liver, heart problems
_ _
•
All other medical condit

Ciri produk

APO-OLANZAPINE TABLETS
OLANZAPINE 5MG AND 10MG TABLETS
ANTIPSYCHOTIC AGENT
PRODUCT DESCRIPTION
5 mg tablets: Each white, round biconvex film-coated tablet, engraved
“APO” on one side and
“OLA” over “5” on the other side. Thickness - 0.167 inch,
Diameter - 0.3125 inch.
10 mg tablets: Each white, round biconvex film-coated tablet, engraved
“APO” on one side and
“OLA” over “10” on the other side. Thickness - 0.200 inch,
Diameter - 0.4062 inch.
PHARMACOLOGY
PHARMACODYNAMICS
Olanzapine, a thienobenzodiazepine, is an antipsychotic agent that
demonstrates a broad
pharmacologic profile across a number of receptor systems. Olanzapine
displays high receptor
affinity binding _in vitro_ at dopamine D
1
, D
3
, D
4
(Ki = 11-31 nM), 5-HT
2A/C
(Ki = 4 and 11 nM,
respectively), 5-HT
3
, 5-HT
6
, muscarinic M
1
-M
5
(Ki = 1.9-2.5 nM), adrenergic α
1
(Ki = 19 nM), and
histamine H
1
(Ki = 7 nM) receptor subtypes, while displaying a lower affinity at
dopamine D
1
and D
5
receptors (Ki = 51 – 119 nM).
Olanzapine also increases extracellular levels of dopamine in a
regionally specific manner in the
prefrontal cortex, similar to mood stabilizers, lithium and valproate.
PHARMACOKINETICS
_Oral Administration:_
Absorption: Olanzapine is well absorbed after oral administration,
reaching peak plasma
concentrations within 5 to 8 hours. The absorption is not affected by
food.
Distribution: Plasma concentrations of orally administered olanzapine
were linear and dose
proportional. The maximum plasma concentrations (C
max
) of olanzapine after single oral doses
of 5, 10 and 15 mg averaged 7, 14, and 21 ng/mL, respectively (20
ng/mL = 0.064 μM). In young
healthy adult, after once-a-day repeated dosing, steady-state C
max
was approximately twice
that achieved after a single dose (e.g. 23 ng/mL versus 12 ng/mL for a
10-mg dose). In the
elderly, the steady state plasma concentration was approximately
3-fold higher than that
achieved after a single dose (e.g. 16 ng/mL versus 5 ng/mL for a 5-mg
dose). In both, young and
eld