NU-FLUCONAZOLE-150 CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

FLUCONAZOLE

Saatavilla:

NU-PHARM INC

ATC-koodi:

J02AC01

INN (Kansainvälinen yleisnimi):

FLUCONAZOLE

Annos:

150MG

Lääkemuoto:

CAPSULE

Koostumus:

FLUCONAZOLE 150MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

OTC

Terapeuttinen alue:

AZOLES

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0122529004; AHFS:

Valtuutuksen tilan:

CANCELLED (UNRETURNED ANNUAL)

Valtuutus päivämäärä:

2018-03-28

Valmisteyhteenveto

PRODUCT MONOGRAPH
NU-FLUCONAZOLE-150
(FLUCONAZOLE)
CAPSULES, 150 MG
ANTIFUNGAL AGENT
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET, UNITS 1 & 2
OCTOBER 20, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 133358
- 1 -
PRODUCT MONOGRAPH
NAME OF DRUG
NU-FLUCONAZOLE-150
(Fluconazole)
Capsules, 150 mg
THERAPEUTIC CLASSIFICATION
Antifungal Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Fluconazole is a highly selective inhibitor of fungal cytochrome P-450
sterol C-14-_alpha_-
demethylation. Mammalian cell demethylation is much less sensitive to
fluconazole inhibition.
The subsequent loss of normal sterols correlates with the accumulation
of 14-_alpha_-methyl
sterols in fungi and may be responsible for the fungistatic activity
of fluconazole.
A standard, randomized, two-way crossover, single-dose bioavailability
study was conducted in
twenty (20) healthy, adult, male volunteers to evaluate the relative
bioavailability of single oral
doses (1
H
150 mg) of NU-FLUCONAZOLE-150 Capsules manufactured by Apotex Inc. and
Diflucan 150® Capsules manufactured by Pfizer Canada Inc.
The mean pharmacokinetic parameters of the 17 subjects completing the
study are listed in the
following table:
- 2 -
SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA
FLUCONAZOLE (DOSE: 150 MG) FROM MEASURED DATA
GEOMETRIC MEAN
ARITHMETIC MEAN (CV%)
PARAMETER
NU-FLUCONAZOLE-150
DIFLUCAN 150®†
RATIO
O
F
GEOMETRIC
MEANS
AUC
0-72h
(
F
g
A
hr/mL)
87.2
89.9 (20.4)
89.6
92.3 (20.8)
97.3
AUC
I
(
F
g
A
hr/mL)
141.9
147.3 (21.5)
140.8
144.8 (21.8)
100.8
C
max
(
F
g/mL)
2.26
2.29 (19.1)
2.76
2.76 (15.4)
81.8
T
max
(h)*
5.33 (60.4)
1.67 (45.1)
--
t
½
(h)*
44.6 (27.4)
42.1 (21.8)
--
*Arithmetic means only (CV%).
†Diflucan 150® is manufactured by Pfizer Canada Inc. and was
purchased in Canada.
INDICATIONS AND CLINICAL USE
Fluconazole capsules are indicated for the oral treatment of:
•
Vaginal candidiasis (yeast infections due to _Candida_).
The diagnosis of vaginal candidiasis should be confirmed by KOH smears
and/or cultures before
initiating therapy with