QUETIAPINE

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

quetiapine fumarate, Quantity: 230.264 mg (Equivalent: quetiapine, Qty 200 mg)

Disponibil de la:

Dr Reddys Laboratories Australia Pty Ltd

INN (nume internaţional):

Quetiapine fumarate

Forma farmaceutică:

Tablet, film coated

Compoziție:

Excipient Ingredients: sodium starch glycollate type A; colloidal anhydrous silica; microcrystalline cellulose; magnesium stearate; lactose monohydrate; calcium hydrogen phosphate dihydrate; povidone; titanium dioxide; hypromellose; macrogol 400

Calea de administrare:

Oral

Unități în pachet:

60 tablet

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Bipolar disorder. Adults = Maintenance treatment of bipolar I disorder, as monotherapy, or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes. = Treatment of depressive episodes associated with bipolar disorder (see Dosage and Administration). = Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate.,Children/adolescents aged 10 to 17 years,= Monotherapy treatment of acute mania associated with bipolar I disorder,Schizophrenia. (Adults and adolescents aged 13 to 17 years) = Treatment of schizophrenia.

Rezumat produs:

Visual Identification: White coloured, round, biconvex film coated tablets, debossed with 'QTP' on one side and '200' on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Statutul autorizaţiei:

Registered

Data de autorizare:

2011-02-24

Prospect

QUETIAPINE-DRLA
CMI V3
1
QUETIAPINE-DRLA
_Quetiapine fumarate_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
QUETIAPINE-DRLA. 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
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.
It is not addictive.
This medicine is available only with
a doctor's prescription.
If it has expired or is damaged, return
it to your pharmacist for disposal.
If you are not sure whether you should
start taking QUETIAPINE-DRLA, talk
to your doctor or pharmacist.
_BEFORE YOU START TO TAKE IT_
TELL YOUR DOCTOR IF YOU HAVE ANY
ALLERGIES TO:
•
any other medicines
benefits. Your doctor will have
•
any other substances, such a
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-
DRLA IS USED FOR
QUETIAPINE-DRLA 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.
QUETIAPINE-DRLA belongs
to a group of medicines called
antipsychotics.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
_ _
DO
NOT TAKE QUETIAPINE- DRLA IF YOU
HAVE AN ALLERGY TO
•
quetiapine, the active ingredient in
the medicine
•
any of the other ingredients listed at
the end of this leaflet.
Some of the symptoms of an allergic
rea

Caracteristicilor produsului

QUETIAPINE-DRLA FILM COATED TABLETS
PRODUCT INFORMATION
NAME OF THE MEDICINE
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:_
_ _
_ _
CAS: 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.
Quetiapine-DRLA 25 mg, 100 mg, 150 mg, 200 mg, and 300 mg tablets
contain
quetiapine fumarate equivalent to 25 mg, 100 mg, 150 mg, 200 mg, and
300 mg
quetiapine free base respectively.
_EXCIPIENTS _ povidone, calcium hydrogen phosphate dihydrate,
cellulose -
microcrystalline,
lactose, sodium starch glycollate, silica - colloidal anhydrous,
magnesium stearate,
hypromellose, macrogol 400, titanium dioxide, iron oxide yellow
CI 77492 (25, 100
and 150 mg) and iron oxide red CI 77491 (25 mg)
PHARMACOLOGY
MECHANISM OF ACTION
Quetiapine is an atypical antipsychotic agent. Quetiapine and the
human plasma
metabolite, norquetiapine, interact with a broad range of
neurotransmitter
Product Information_v3
Page 2 of 41
receptors. Quetiapine 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 compared to typical antipsychotics.
Additionally,
norquetiapine has high affinity (higher than quetiapine) for the
noradrenaline
tra