ZYM-CLONAZEPAM TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CLONAZEPAM

Dostupno od:

ZYMCAN PHARMACEUTICALS INC

ATC koda:

N03AE01

INN (International ime):

CLONAZEPAM

Doziranje:

0.5MG

Farmaceutski oblik:

TABLET

Sastav:

CLONAZEPAM 0.5MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Targeted (CDSA IV)

Područje terapije:

BENZODIAZEPINES

Proizvod sažetak:

Active ingredient group (AIG) number: 0111558001; AHFS:

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2010-02-12

Svojstava lijeka

PRODUCT MONOGRAPH
Zym-CLONAZEPAM
(Clonazepam Tablets USP)
0.25mg , 0.5 mg, 1.0 mg and 2.0 mg
Anticonvulsant
Zymcan Pharmaceuticals Inc.
Date of Preparation
6111 Royalmount Ave.
December 4, 2007
Montreal, Quebec
H4P 2T4
Control # 118488
2
PRODUCT MONOGRAPH
ZYM-CLONAZEPAM
(Clonazepam Tablets)
0.25 mg, 0.5 mg, 1 mg & 2 mg
THERAPEUTIC CLASSIFICATION
Anticonvulsant
ACTIONS AND CLINICAL PHARMACOLOGY
Clonazepam has pharmacological properties characteristic of the
benzodiazepine class of drugs.
Clonazepam has sedative, hypnotic and anticonvulsant properties. As an
anticonvulsant it is useful
in the management of minor motor seizures (myoclonic seizures) and may
be of some value in
selected patients with absence spells (petit mal) who have failed to
respond to succinimides.
Clonazepam is capable of suppressing the spike and wave discharge in
absence seizures (petit mal)
and decreasing the frequency, amplitude, duration and spread of
discharge in minor motor seizures.
Single oral doses of clonazepam to healthy volunteers gives maximum
blood levels of drug, in 1 to
3 hours. The half-life of the parent compound ranges from
approximately 18 to 50 hours. The
major route of excretion of clonazepam is the urine. A comparative
bioavailability study was
performed using normal human volunteers. The rate and extent of
absorption after a single oral dose
of the test product clonazepam 2 mg manufactured by Zymcan
Pharmaceuticals Inc., vs. the
reference product Rivotril 2 mg manufactured by Hoffman Laroche was
measured and compared.
The results can be summarized as follows:
3
SUMMARY OF COMPARATIVE BIOAVAILABILITY
DATA
GEOMETRIC MEAN
ARITHMETIC MEAN (C.V.)
PARAMETERS
TEST - 2.0mg
REFERENCE - 2.0mg
RATIO
AUC
t
(ng.hr/mL)
392.02
398.22 (17.48)
364.95
372.26 (19.86)
107.42%
AUC
(ng.hr/mL)
459.71
466.40 (16.84)
428.70
434.63 (16.70)
107.23%
C
max
(ng/mL
10.56
10.71 (15.90)
10.03
10.21 (19.19)
105.33%
T
max
* (hours)
2.57 (1.81)
2.56 (2.31)
---------
T
1/2
el * (hours)
35.93 (7.32)
34.06 (7.06)
----------
* For the Tmax and T
1/2
el paramet