OLANZAPINE RBX ODT olanzapine 10 mg orally disintegrating tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Olanzapine

Disponible depuis:

Torrent Australasia Pty Ltd

DCI (Dénomination commune internationale):

Olanzapine

Notice patient

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 RBX
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 RBX
ODT IS USED FOR
OLANZAPINE RBX ODT belongs to a group of medicines
called
antipsychotics.
It
helps
to
correct
chemical
imbalances in the brain, which may cause mental illness.
OLANZAPINE RBX ODT is used to treat symptoms of
schizophrenia and related psychoses. Schizophrenia is a
mental illness with disturbances in thinking, feelings and
behaviour.
OLANZAPINE RBX 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 RBX 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 OLANZAPINE RBX

Résumé des caractéristiques du produit

Page 1 of 18
PRODUCT INFORMATION
OLANZAPINE RBX 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 RBX 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 RBX ODT is available as 5 mg and 10 mg orally
disintegrating tablets.
OLANZAPINE RBX ODT contains the active ingredient, olanzapine.
The tablets also contain the following inactive ingredients: mannitol,
aspartame, crospovidone,
microcrystalline cellulose, magnesium stearate.
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. Olanzapine reduced a
conditioned avoidance response, a test indicative of antipsychotic
activity, at doses belo