OZIN 7.5 olanzapine 7.5 mg tablets bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
olanzapine, Quantity: 7.5 mg
Available from:
Strides Pharma Science Pty Ltd
INN (International Name):
Olanzapine
Pharmaceutical form:
Tablet, uncoated
Composition:
Excipient Ingredients: lactose monohydrate; crospovidone; magnesium stearate; hyprolose
Administration route:
Oral
Units in package:
30
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Olanzapine is indicated for the treatment of schizophrenia and related psychoses. ,Olanzapine alone or in combination with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder. ,Olanzapine is indicated for preventing recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.
Product summary:
Visual Identification: Yellow coloured, circular, biconvex uncoated tablets, debossed with "C" on one side and "47" on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2011-11-15
Patient Information leaflet
OZIN™ 2.5, 5, 7.5 & 10
CONSUMER MEDICINE INFORMATION
Olanzapine tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions people ask about OZIN.
It does not contain all the available information. It does not take
the place of talking to your doctor or
pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking OZIN
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 THE MEDICINE.
You may need to read it again.
WHAT OZIN IS USED FOR
OZIN belongs to a group of medicines called antipsychotics. It helps
to correct chemical imbalances
in the brain, which may cause mental illness.
OZIN is used to treat symptoms of schizophrenia and related psychoses.
Schizophrenia is a mental
illness with disturbances in thinking, feelings and behaviour.
OZIN 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 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 for another reason.
ALWAYS ASK YOUR DOCTOR IF YOU NEED MORE INFORMATION.
This medicine is available only with a doctor’s prescription.
OZIN 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:
IF YOU HAVE HAD AN ALLERGIC REACTION TO OZIN OR TO ANY OF THE
INGREDIENTS LISTED
Read the complete document
Summary of Product characteristics
Page 1 of 17
PRODUCT INFORMATION
OZIN
TM 2.5, 5, 7.5 & 10
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 tablets contain either 2.5 mg, 5 mg, 7.5 mg or 10 mg of
olanzapine.
INACTIVE: lactose, crospovidone, hydroxypropylcellulose & magnesium
stearate._ _
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 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, 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 increased responding in an ‘anxiolytic’ test.
Page 2 of 17
In a single 10 mg oral dose Positron Emission Tomography (PET) study
in healthy volunteers,
olanzapine produced higher receptor oc
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