TOLANZ TABLET 5 MG

国家: 马来西亚

语言: 英文

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

有效成分:

OLANZAPINE

可用日期:

LABORATORIES TORRENT (MALAYSIA) SDN. BHD.

INN（国际名称）:

OLANZAPINE

每包单位数:

30tablet Tablets; 100tablet Tablets; 10tablet Tablets

厂商:

TORRENT PHARMACEUTICALS LTD.

资料单张

TOLANZ TABLET
_ _
Olanzapine (5 mg, 10 mg)
_ _
_ _
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What is Tolanz used for
2.
How Tolanz works
3.
Before you use Tolanz
4.
How to use Tolanz
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Tolanz
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TOLANZ IS USED FOR
Olanzapine
belongs
to
a
group
of
medicines called antipsychotics and is
used to treat the following conditions:
•
Schizophrenia,
a
disease
with
symptoms such as hearing, seeing
or
sensing
things
which
are
not
there,
mistaken
beliefs,
unusual
suspiciousness,
and
becoming
withdrawn.
People
with
this
disease
may
also
feel
depressed,
anxious or tense.
•
Maintaining
the
clinical
improvement
during
continuation
therapy in people who have shown
an initial treatment response.
•
Moderate
to
severe
manic
episodes,
a
condition
with
symptoms
of
excitement
or
euphoria.
Tolanz
has
been
shown
to
prevent
recurrence
of
these
symptoms
in
individual with bipolar disorder whose
manic episode has responded to Tolanz
treatment.
HOW TOLANZ WORKS
Olanzapine acts on a receptors named
as
serotonin
receptors
and by
this
it
exhibits antipsychotic properties.
BEFORE YOU USE TOLANZ
-
_When you must not use it _
Do not take Tolanz:
•
If you are allergic (hypersensitive)
to olanzapine or any of the other
ingredients of Tolanz. An allergic
reaction may be recognized as a
rash,
itching,
a
swollen
face,
swollen lips or shortness of breath.
If this has happened to you, tell
your doctor.
•
If
you
have
been
previously
diagnosed with eye problems such
as
certain
kinds
of
glaucoma
(increased pressure in the eye).
_Pregnancy and lactation_
_ _
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning
to
have
a
baby,
ask
your
doctor
for
advice
before
taking
this
medicine.
You should not be given this medicine
when breast-feeding, as small amounts
of Tolanz can pass into breast milk. Ask
your
doctor
or
pharmacist
for

产品特点

xxxxxxxx-xxxx
For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only.
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
TOLANZ TABLET 5 MG
Each uncoated tablet contains
Olanzapine USP 5 mg
TOLANZ TABLET 10 MG
Each uncoated tablet contains
Olanzapine USP 10 mg
DOSAGE FORM
Uncoated Tablets
PRODUCT DESCRIPTION
TOLANZ TABLET 5 MG
Yellow colored, round, biconvex uncoated tablets debossed with “5”
on one side and “67”
on other side.
TOLANZ TABLET 10 MG
Yellow colored, round, biconvex uncoated tablets debossed with
“10” on one side and “169”
on other side.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Olanzapine is an antipsychotic agent that demonstrates a broad
pharmacologic profile
across a number of receptor systems. Olanzapine exhibited a range of
receptor affinities
(Ki; < 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5HT6; dopamine D1, D2,
D3, D4, D5;
cholinergic muscarinic. It is reported that olanzapine reduced a
conditioned avoidance
response, a test indicative of antipsychotic activity, at doses below
those producing
catalepsy, an effect indicative of motor side-effects. Unlike some
other antipsychotic
agents, olanzapine increases responding in an “anxiolytic” test.
Olanzapine produced a higher 5-HT2 A than dopamine D2 receptor
occupancy. In addition,
olanzapine-responsive
patients
had
lower
striatal
D2
occupancy
than
some
other
antipsychotic
and
risperidone-responsive
patients,
while
being
comparable
to
clozapineresponsive patients.
It
is
reported
that
olanzapine
was
associated
with
statistically
significantly
greater
improvements in negative as well as positive symptoms.
PHARMACOKINETICS
Olanzapine is well absorbed after oral administration reaching peak
plasma concentrations
within 5 to 8 hours. The absorption is not affected by food.
Olanzapine is metabolized in the liver by conjugative and oxidative
pathways. The major
circulating metabolite is the 10-N-glucuronide which does not pass the
blood brain barrier.
Cytochromes P450- CYP1A2 and P450-CYP2D6 contribute to the formation