OLANZAPINE TORRENT ODT 5 olanzapine 5 mg orally disintegrating tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine

Available from:

Torrent Australasia Pty Ltd

INN (International Name):

Olanzapine

Authorization status:

Registered

Patient Information leaflet

Page 1 of 6
CONSUMER MEDICINE INFORMATION OLANZAPINE TORRENT ODT
_Olanzapine orally disintegrating tablets_
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some
common questions about this
medicine. It does not contain all
the available information and
does not take the place of talking
with your doctor.
The information in this leaflet was
last updated on the date shown
on the final page. More recent
information about this medicine
may be available. Make sure you
speak to your pharmacist or
doctor to obtain the most up to
date information on this medicine.
The updated leaflet may contain
important information about
OLANZAPINE TORRENT ODT
and its use that you should be
aware of.
All medicines have risks and
benefits.
Your doctor has more information
about this medicine than is
contained in this leaflet. Also,
your doctor has had the benefit of
taking a full and detailed history
from you and is in the best
position to make an expert
judgement to meet your individual
needs.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE.
You may need to read it again.
WHAT OLANZAPINE
TORRENT ODT IS USED FOR
OLANZAPINE TORRENT ODT
belongs to a group of medicines
called antipsychotics. It helps to
correct chemical imbalances in
the brain, which may cause
mental illness.
OLANZAPINE TORRENT ODT is
used to treat symptoms of
schizophrenia and related
psychoses. Schizophrenia is a
mental illness with disturbances
in thinking, feelings and
behaviour.
OLANZAPINE TORRENT ODT
alone, or in combination with
lithium or valproate, is used for
the short-term treatment of acute
manic episodes associated with
Bipolar I Disorder. OLANZAPINE
TORRENT ODT is also a mood
stabiliser that prevents further
occurrences of the disabling high
and low (depressed) extremes of
mood associated with Bipolar I
Disorder.
Bipolar I Disorder is a mental
illness with symptoms such as
feeling “high”, having excessive
amounts of energy, needing
much less sleep

Summary of Product characteristics

Page 1 of 18
PRODUCT INFORMATION
OLANZAPINE TORRENT ODT
_Olanzapine orally disintegrating tablets _
NAME OF THE MEDICINE
Chemical name:
2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine.
Empirical formula: C
17
H
20
N
4
S.
Molecular weight: 312.44 g/mol
CAS Registry no.: 132539-06-1
Structural formula:
DESCRIPTION
Olanzapine is a yellow crystalline solid that is practically insoluble
in water.
Olanzapine Torrent ODT orally disintegrating tablets are a freeze
dried, rapid dispersing
preparation to be placed in the mouth or alternatively to be dispersed
in water or other suitable
beverage (not cola beverages) for administration.
Olanzapine Torrent ODT is available as 5 mg and 10 mg orally
disintegrating tablets. Olanzapine
Torrent ODT contains the active ingredient, olanzapine.
The tablets also contain the following inactive ingredients: mannitol,
aspartame, crospovidone,
microcrystalline cellulose, magnesium stearate.
_olanzapine orally disintegrating tablets _
_Product Information _
_ _
_ _
_ _
_V1.0_
Page 2 of 18
PHARMACOLOGY
PHARMACODYNAMICS
ACTIONS: Olanzapine is an atypical antipsychotic, antimanic and mood
stabilising agent that
demonstrates a broad pharmacological profile across a number of
receptor systems.
In preclinical studies, olanzapine exhibited a range of receptor
affinities (Ki; < 100 nmol) 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 behavioural 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 in _in vivo _models, greater 5HT
2
than D
2
activity. 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. Olanzapin