Onzapin Orodispersible Tablet 10mg

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

OLANZAPINE

Dostupné s:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Mezinárodní Name):

OLANZAPINE

Jednotky v balení:

28 Tablets

Výrobce:

Actavis Ltd.

Informace pro uživatele

Consumer Medication Information Leaflet (RiMUP)
ONZAPIN ORODISPERSIBLE TABLETS
Olanzapine orodispersible (5mg,10mg)
_ _
_ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Onzapin is used for
2.
How Onzapin works
3.
Before you use Onzapin
4.
How to take Onzapin
5.
While
you
are
using
Onzapin
6.
Side Effects
7.
Storage
and
Disposal
of
Onzapin
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ONZAPIN IS USED FOR
Olanzapine belongs to a group
of
medicines
called
antipsycotics 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withdrawn.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.
-Moderate
to
severe
manic
episodes,
a
condition
with
symptoms
of
excitement
or
euphoria. Olanzapine has been
shown to prevent recurrence of
these symptoms in patients with
bipolar
disorder
whose
manic
episode
has
responded
to
olanzapine treatment.
HOW ONZAPIN WORKS
Olanzapine
is
in
a
class
of
medications
called
atypical
antipsychotics.
It
works
by
changing the activity of certain
natural substances in the brain.
BEFORE YOU USE ONZAPIN
_-When you must not take it _
Do not take olanzapine:
-If
you
are
allergic
(hypersensitive)
to
olanzapine
or any of the other ingredients
of this medicine. An allergic
reaction may be recognised 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).
_-Before you start to take it _
Talk
to
your
doctor
or
pharmacist
before
you
take
olanzapine:
-The
use
of
olanzapine
in
elderly patients with dementia is
not
recommended
as
it
may
have serious side effects.
-Medicines
of
this
type
may
cause
unusual
movements
mainly of the face or tongue. If
this
happens
after
you
have
been given olanzapine tell your
doctor.
-Very rarely

Charakteristika produktu

ONZAPIN ORODISPERSIBLE TABLETS
DESCRIPTION
5mg: Yellow tablets, 6 mm round, biconvex. Markings O
10mg: Yellow tablets, 8 mm round, biconvex. Markings O1
COMPOSITION
Each Onzapin Orodispersible tablets 5mg contains 5mg olanzapine.
Each Onzapin Orodispersible tablets 10mg contains 10mg olanzapine.
PHARMACOLOGY
Olanzapine is an antipsychotic, antimanic, and mood stabilising agent
that
demonstrates a broad pharmacologic profile across a number of receptor
systems.
In preclinical studies, olanzapine exhibited a range of receptor
affinities
(K
i
<100nM) for serotonin 5HT
2A/2C
, 5HT
3
, 5HT
6
; dopamine D
1
, D
2
, D
3
, D
4
, D
5
;
cholinergic muscarinic receptors M
1
-M
5
; α
1
adrenergic; and histamine H
1
receptors.
Animal behavioral studies with olanzapine indicated 5HT, dopamine, and
cholinergic antagonism, consistent with the receptor-binding profile.
Olanzapine
demonstrated a greater _in vitro_ affinity for serotonin 5HT
2
than dopamine D
2
receptors and greater 5HT
2
than D
2
activity in _in vivo_ models. Electrophysiological
studies demonstrated that olanzapine selectively reduced the firing of
mesolimbic
(A10) dopaminergic neurons, while having little effect on the striatal
(A9)
pathways involved in motor function. 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.
PHARMACOKINETICS
_Absorption_
Olanzapine
is
well
absorbed
after
oral
administration,
reaching
peak
plasma
concentrations within 5 to 8 hours. The absorption is not affected by
food. Absolute
oral bioavailability relative to intravenous administration has not
been determined.
Olanzapine orodispersible tablet is bioequivalent to olanzapine coated
tablets,
with a similar rate and extent of absorption. Olanzapine
orodispersible tablets may
be used as an alternative to olanzapine coated tablets.
_Biotransformation_
Olanza