OZIN ODT 15 olanzapine 15 mg orally disintegrating tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
29-10-2015
Summary of Product characteristics
(SPC)
29-10-2015
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
Olanzapine
Available from:
Aurobindo Pharma Australia Pty Ltd
INN (International Name):
Olanzapine
Patient Information leaflet
OZIN ODT
TM 5, 10, 15 & 20
CONSUMER MEDICINE INFORMATION
Olanzapine orally disintegrating tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions people ask about OZIN ODT.
It does not contain all the available information. It does not take
the place of talking with your doctor
or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking OZIN
ODT against the benefits they expect it will have for you..
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS MEDICINE.
You may need to read it again.
WHAT OZIN ODT IS USED FOR
OZIN ODT belongs to a group of medicines called antipsychotics. It
helps to correct chemical
imbalances in the brain, which may cause mental illness.
OZIN ODT is used to treat symptoms of schizophrenia and related
psychoses. Schizophrenia is a
mental illness with disturbances in thinking, feelings and behaviour.
OZIN 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. OZIN 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 racing ideas and
sometimes severe irritability.
Your doctor may have prescribed OZIN ODT for another reason.
ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION.
This medicine is available only with a doctor's prescription.
OZIN ODT is not recommended for use in children under the age of 18
years as there is not enough
information on its effects in this age group.
BEFORE YOU TAKE IT
_ _
TELL YOUR DOCTOR IF YOU HAVE ANY OF THE FOLLOWING CONDITIONS OR IF YOU
HAVE EVER EXPERIENCED
ANY OF THESE CONDITIONS.
_WHEN YOU MUST NOT TAKE IT: _
_ _
DO NOT TAKE OZIN ODT:
IF YOU HAVE HAD AN
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Summary of Product characteristics
Page 1 of 18
PRODUCT INFORMATION
OZIN ODT
TM 5, 10, 15 & 20
ORALLY DISINTEGRATING TABLETS
NAME OF THE MEDICINE
Active ingredient
Olanzapine
Chemical name
2-Methyl-4-(4-methylpiperazin-1-yl)-10_H_-thieno[2,3-
_b_][1,5]benzodiazepine
Molecular formula
C
17
H
20
N
4
S
Molecular weight
312.4
CAS number
132539-06-1
Chemical structure:
DESCRIPTION
Olanzapine is a yellow, crystalline powder. It is practically
insoluble in water, freely soluble in
methylene chloride, slightly soluble in ethanol (96 per cent).
OZIN ODT is available as orally disintegrating tablets containing 5
mg, 10 mg, 15 mg & 20 mg
olanzapine.
OZIN ODT orally disintegrating tablets contain the following inactive
ingredients:
mannitol,
polacrilin potassium, crospovidone, microcrystalline cellulose,
aspartame, colloidal anhydrous
silica, sodium stearyl fumarate and the proprietary ingredient,
artificial pineapple FL SD #883.
PHARMACOLOGY
PHARMACODYNAMICS
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 m1-
m5; 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, a test indicative of antipsychotic
activity, at doses below those
Page 2 of 18
producing catalepsy, an effect indicative of m
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