CLOZARIL clozapine 25mg tablet bottle

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

clozapine, Quantity: 25 mg

Boleh didapati daripada:

Viatris Pty Ltd

Borang farmaseutikal:

Tablet, uncoated

Komposisi:

Excipient Ingredients: magnesium stearate; purified talc; maize starch; povidone; colloidal anhydrous silica; lactose monohydrate

Laluan pentadbiran:

Oral

Unit dalam pakej:

100 tablets

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Clozaril is indicated in treatment-resistant schizophrenic patients only, i.e. schizophrenic patients who are non-responsive to, or intolerant of other antipsychotic drugs. Non-responsiveness is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two classes of marketed antipsychotic drugs prescribed for reasonable durations. Intolerance is defined as the impossibility to achieve adequate benefit with other antipsychotic drugs because of severe and untreatable neurological adverse reactions (extrapyramidal side effects or tardive dyskinesia).

Ringkasan produk:

Visual Identification: Circular, flat, yellow, bevelled edged tablet. Approximately 6.3 mm diameter, coded "CLOZ" on,one side and "L/O" and angle score on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status kebenaran:

Registered

Tarikh kebenaran:

2001-08-22

Ciri produk

AUSTRALIAN PRODUCT INFORMATION
CLOZARIL
_Clozapine tablets _
WARNING
_Clozapine induced gastrointestinal hypomotility _
Clozapine induced gastrointestinal hypomotility: Severe
gastrointestinal adverse reactions have
occurred with the use of clozapine resulting in potential outcomes of
hospitalisation, surgery and
death (see Section 4.4 Special warnings and precautions for use, and
Section 4.8 Adverse effects
(undesirable effects)). Prior to initiating and during treatment with
CLOZARIL, screen for
constipation and if necessary, manage as per current clinical
guidelines.
_ _
_Myocarditis _
Cases of myocarditis, some of which have been fatal, and
cardiomyopathy have been reported in
patients on clozapine (see "4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE" and "4.8
ADVERSE
EFFECTS
(UNDESIRABLE
EFFECTS)").
If
myocarditis
or
cardiomyopathy
is
suspected,
Clozaril
treatment
should
be
stopped
and
the
patient
immediately
referred
to
a
cardiologist.
Generally,
patients
with
a
history
of
clozapine-associated
myocarditis
or
cardiomyopathy should not be rechallenged with Clozaril.
1
NAME OF THE MEDICINE
Clozapine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Clozaril tablet contains clozapine 25 mg or 100 mg of the active
ingredient, clozapine.
Excipients with known effect: sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tablets, uncoated.
25 mg tablet: Circular, flat, yellow, bevelled edged tablets.
Approximately 6.3 mm diameter, coded “CLOZ”
on one side, and “L/O” and angle score on the reverse.
100 mg tablet: Circular, flat, yellow, bevelled edged tablets.
Approximately 10 mm diameter, coded “CLOZ”
on one side, and “Z/A” and angle score on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment with Clozaril is indicated in treatment-resistant
schizophrenic patients only, i.e. schizophrenic
patients who are non-responsive to, or intolerant of, other
antipsychotic drugs.
NON-RESPONSIVENESS
is defined as lack of satisfactory cli