KAPTAN quetiapine (as fumarate) 100 mg film-coated tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

quetiapine fumarate

Beszerezhető a:

Strides Pharma Science Pty Ltd

INN (nemzetközi neve):

Quetiapine fumarate

Engedélyezési státusz:

Registered

Betegtájékoztató

KAPTAN
Consumer Medicine Information
Quetiapine (as fumarate) 25 mg, 100 mg, 200 mg and 300 mg film-coated
tablets
What is in this leaflet
This leaflet answers some of the common questions people ask about
KAPTAN. 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 is KAPTAN used for
KAPTAN 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; or

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.
KAPTAN belongs to a group of medicines called antipsychotics.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY KAPTAN HAS BEEN
PRESCRIBED
FOR YOU.
Your doctor may prescribe this medicine for another reason. KAPTAN is
not addictive.
This medicine is available only with a doctor's prescription.
Before you take KAPTAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE KAPTAN IF YOU HAVE AN ALLERGY TO:

quetiapine (as fumarate), the active ingredient in the medicine; or

any of the other ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include shortness of
breath, wheezing
or difficulty breathing, swelling of the face, lips, tongue or other
parts of the body; rash, itching
or hives on the skin or you may feel faint.
DO NOT GIVE KAPTAN TO CHILDREN OR ADOLESCENTS UNLESS RECOMMENDED BY
YOUR DOCTOR.
The effects of KAPTAN have only been

Termékjellemzők

Page 1 of 41
PRODUCT INFORMATION
KAPTAN
25 MG, 100 MG, 200 MG & 300 MG
FILM-COATED TABLETS
NAME OF THE MEDICINE
The active ingredient in KAPTAN is Quetiapine as quetiapine fumarate
Chemical name: bis[2-(2-[4-(dibenzo[b,f][1,4] -thiazepin-11-yl)
piperazin-1-yl] ethoxy)
ethanol] fumarate.
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 mg/mL 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: _ Povidone, calcium hydrogen phosphate, microcrystalline
cellulose, lactose,
sodium starch glycollate type A, magnesium stearate, hypromellose,
macrogol 400,
titanium dioxide, iron oxide yellow (25 mg and 100 mg) and iron oxide
red (25 mg).
Page 2 of 41
PHARMACOLOGY
_MECHANISM OF ACTION_
Quetiapine (as fumarate) is an atypical antipsychotic agent.
Quetiapine (as fumarate)
and
the
human
plasma
metabolite, norquetiapine, interact with a broad range of
neurotransmitter receptors. Quetiapine (as fumarate) and norquetiapine
exhibit affinity
for
brain
serotonin
(5HT
2
)
and
dopamine D
1
and D
2
receptors; this combination of
receptor antagonism with a higher selectivity for 5HT
2
relative to D
2
receptors is believed
to contribute to the clinical antipsychotic properties and low
extrapyramidal side effects
(EPS)
liability
of
quetiapine
(as
fumarate)
compared
to
typical
antipsychotics.
Additionally, norquetiapine has high
affinity (higher than quetiapine (as fumarate)) for
the
noradrenaline
transporter,
5HT
1B
and
muscarinic
receptors.
Quetiapine
(as
fumarate) and norquetiapine also have high affinity at histaminergic H
1
and adrenergic