FLUCONAZOLE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUCONAZOLE

Available from:

TEVA CANADA LIMITED

ATC code:

J02AC01

INN (International Name):

FLUCONAZOLE

Dosage:

2MG

Pharmaceutical form:

SOLUTION

Composition:

FLUCONAZOLE 2MG

Administration route:

INTRAVENOUS

Units in package:

100/200ML

Prescription type:

Prescription

Therapeutic area:

AZOLES

Product summary:

Active ingredient group (AIG) number: 0122529003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-09-15

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
TEVA-FLUCONAZOLE
Fluconazole Tablets
Teva Standard
50mg and 100 mg
PR
FLUCONAZOLE INJECTION
Solution for Intravenous Infusion
2 mg/mL
(100 mL vial; and 100 mL and 200 mL Cryovac bags)
Antifungal Agent
Teva Canada Limited
DATE OF REVISION:
30 Novopharm Court
June 2, 2017
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
SUBMISSION CONTROL: 205383
2
PRODUCT MONOGRAPH
PR
TEVA-FLUCONAZOLE
Fluconazole Tablets
50 and 100 mg
Pr
FLUCONAZOLE INJECTION
Solution for Intravenous Infusion
2 mg/mL
(100 mL vial; and 100 mL and 200 mL Cryovac bags)
THERAPEUTIC CLASSIFICATION
Antifungal
ACTION AND CLINICAL PHARMACOLOGY
Fluconazole
is
a
highly
selective
inhibitor
of
fungal
cytochrome
P-450
sterol
C-14-α-
demethylation. Mammalian cell demethylation is much less sensitive to
fluconazole inhibition.
The subsequent loss of normal sterols correlates with the accumulation
of 14-α-methyl sterols in
fungi and may be responsible for the fungistatic activity of
fluconazole.
A randomized, blinded, two-period, two-treatment, crossover
bioequivalence study of TEVA-
FLUCONAZOLE 100 mg tablets (Teva Canada Ltd.) and DIFLUCAN
®
(Fluconazole) 100 mg
tablets (Pfizer Canada, Canada) administered as a single 2 x 100 mg
dose was conducted in
healthy male subjects (n=16) under fasting conditions. The results
from the measured data are
summarized in the table below.
3
TABLE 1
_Fluconazole _
_(2 x 100 mg) _
_From measured data _
_ _
_Geometric Mean _
_ _
_ _
_ _
_ _
_Arithmetic Mean (CV %)_
_Parameter_
_ Test_
_*_
_ Reference_
_†_
_% Ratio of _
_Geometric Means_
_90% Confidence _
_Interval_
_AUC_
_T_
_ _
_(mcg_

_hr/mL) _
192.65
193.84
(11.25)
185.88
186.59
(8.70)
103.64
100.27-107.12
_AUC_
_0-72_
_ _
_(mcg_

_hr/mL) _
151.14
151.85
(10.08)
145.44
145.83
(7.44)
103.92
100.51-107.44
_AUC_
_I_
_ _
_(mcg_

_hr/mL) _
202.17
203.50
(11.61)
195.70
196.37
(8.35)
103.31
99.89-106.84
_C_
_max_
_ _
_(mcg/mL) _
4.34
4.38
(12.47)
4.32
4.39
(17.65)
100.49
95.52-105.71
_T_
_max_
_§_
_ _
_(h) _
1.31
(71.44)
1.86
(79.77)
_T_
_1/2_
_�