QUETIAPINE-SYNTHON
Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Informasjon til brukeren
(PIL)
12-05-2024
Preparatomtale
(SPC)
12-05-2024
Aktiv ingrediens:
Quetiapine fumarate
Tilgjengelig fra:
Synthon Au Pty Ltd
Klasse:
Medicine Registered
Informasjon til brukeren
QUETIAPINE-SYNTHON CMI
MAY 2012
Page 1 of 9
QUETIAPINE-SYNTHON
_Quetiapine fumarate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about QUETIAPINE-
SYNTHON. 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 it 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 QUETIAPINE-SYNTHON IS USED FOR
QUETIAPINE-SYNTHON is an antipsychotic medicine that is only available with a
doctor’s prescription. It helps to correct chemical imbalances in the brain. It is used to
treat conditions such as:
• Schizophrenia, an illness with disturbances in
thinking, feelings and behaviour
• Bipolar disorder, an illness in which there are sustained mood swings either up
(mania) or down (depression). During mania, patients experience episodes of
overactivity, elation or irritability. During depression, patients may feel depressed
or guilty, lack energy, lose their appetite and have trouble
sleeping.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may prescribe this medicine for another reason.
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QUETIAPINE-SYNTHON PRODUCT INFORMATION
MAY 2012
Page 1 of 40
QUETIAPINE-SYNTHON
_Quetiapine fumarate _
PRODUCT INFORMATION
_ _
NAME OF THE MEDICINE
QUETIAPINE-SYNTHON (quetiapine fumerate)
Active: Quetiapine as quetiapine fumarate
Chemical name: bis[2-(2- [4-(dibenzo[b,f][1,4] -thiazepin-11-yl) piperazin-1-yl]
ethoxy) ethanol] fumarate.
Quetiapine fumarate has no chiral centres and only one morphological entity has
been detected throughout development.
Structural Formula:
Molecular Formula: 2(C
21
H
25
N
3
O
2
S)
.
C
4
H
4
O
4
Molecular Weight 883.09
CAS number: 111974-72-2.
DESCRIPTION
Quetiapine fumarate is a weak acid (pKa 3.3, 6.8) which exhibits moderate pH
dependent solubility (94.3 to 2.37 mg/mL at pH values from 1 to 9) and lipophilicity
characteristics (log P) which vary with pH (0.45 in water, 1.37 at pH 5, 2.65 at pH 7
and 2.59 at pH 9).
Quetiapine fumarate displays good solid state stability, has an aqueous solubility of
3.29 mg/mL at 25°C and exhibits suitable tableting properties when combined with
appropriate excipients.
Excipients are: Povidone, calcium hydrogen phosphate, cellulose-microcrystalline,
lactose, sodium starch glycollate type A, magnesium stearate, hypromellose,
QUETIAPINE-SYNTHON PRODUCT INFORMATION
MAY 2012
Page 2 of 40
macrogol 400, titanium dioxide, iron oxide yellow C177492 (25 mg and 100 mg) and
iron oxide red C177491 (25 mg).
PHARMACOLOGY
MEC
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