TORRENIA ODT 5 olanzapine 5 mg orodispersible tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

olanzapine, Quantity: 5 mg

Available from:

Torrent Australasia Pty Ltd

INN (International Name):

Olanzapine

Pharmaceutical form:

Tablet, orally disintegrating

Composition:

Excipient Ingredients: mannitol; aspartame; crospovidone; microcrystalline cellulose; magnesium stearate

Administration route:

Oral

Units in package:

28 tablets in blisters

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of schizophrenia and related psychoses. Short-term treatment, alone or in combination with lithium or valproate, of acute manic episodes assoicated with bipolar I disorder. Preventing recurrence of manic, mixed or depressive episodes in bipolar I disorder.

Product summary:

Visual Identification: Yellow coloured, round, flat, bevel edged uncoated orodispersible tablet with break line on one side and plain on other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-01-18

Patient Information leaflet

131118 Torrenia ODT CMI v 2
Page 1 of 6
CONSUMER MEDICINE INFORMATION
TORRENIA 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
Torrenia 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 TORRENIA ODT IS
USED FOR
Torrenia ODT belongs to a group
of medicines called antipsychotics.
It helps to correct chemical
imbalances in the brain, which
may cause mental illness.
Torrenia ODT is used to treat
symptoms of schizophrenia and
related psychoses. Schizophrenia
is a mental illness with
disturbances in thinking, feelings
and behaviour.
Torrenia 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. Torrenia 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 than usual,
talking very quickly with rac

Summary of Product characteristics

Page 1 of 19
PRODUCT INFORMATION
TORRENIA 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.
Torrenia 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.
Torrenia ODT is available as 5 mg and 10 mg orally disintegrating
tablets. Torrenia 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 _
_V1.5 13122011_
Page 2 of 19
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. Olanzapine reduced a
conditioned avoidance response,