PMS-CLOZAPINE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CLOZAPINE

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

N05AH02

INN (nume internaţional):

CLOZAPINE

Dozare:

25MG

Forma farmaceutică:

TABLET

Compoziție:

CLOZAPINE 25MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ATYPICAL ANTIPSYCHOTICS

Rezumat produs:

Active ingredient group (AIG) number: 0122583001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2011-01-20

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
PMS-CLOZAPINE
(Clozapine Tablets)
25 mg and 100 mg
ANTIPSYCHOTIC AGENT
PHARMASCIENCE INC.
Date of Preparation:
6111 Royalmount Avenue, Suite #100,
1999.07.28
Montréal, Quebec
Date of Revision:
H4P 2T4
September 16, 2004
Control #93035
- 2 -
PRODUCT MONOGRAPH
PR
PMS-CLOZAPINE
(Clozapine)
THERAPEUTIC CLASSIFICATION
Antipsychotic Agent
ACTION AND CLINICAL PHARMACOLOGY
pms-CLOZAPINE (clozapine), a dibenzodiazepine derivative, is an
atypical antipsychotic drug
because its profile of binding to dopamine receptors and its effects
on various dopamine-mediated
behaviours differ from those exhibited by conventional antipsychotics.
In contrast to conventional
antipsychotics, clozapine produces little or no prolactin elevation.
Clozapine exerts potent
anticholinergic, adrenolytic, antihistaminic and antiserotoninergic
activity.
Controlled clinical trials indicate that clozapine improves both
positive and negative symptoms.
Patients on rare occasions may report an intensification of dream
activity during clozapine therapy.
Rapid eye movement (REM) sleep was found to be increased to 85% of the
total sleep time. In these
patients, the onset of REM sleep occurred almost immediately after
falling asleep.
As is true of more typical antipsychotic drugs, clinical EEG studies
have shown that clozapine
increases delta and theta activity and slows dominant alpha
frequencies. Enhanced synchronization
occurs, and sharp wave activity and spike and wave complexes may also
develop.
- 3 -
P
HARMACOKINETICS
The absorption of orally administered clozapine is 90 to 95%. Food
does not affect either the rate
or the extent of absorption. Clozapine is subject to first-pass
metabolism, resulting in an absolute
bioavailability of 50 to 60%.
Plasma concentrations show large inter-individual differences, with
peak concentrations occurring
approximately 2.5 hours (range: 1 to 6 hours) after dosing. In a dose
range of 37.5 mg bid to 150 mg
bid, the area under the curve (AUC) and the peak plasma concentration
(C
max
) increase linear