RIVA-FLUCONAZOLE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

FLUCONAZOLE

Dostopno od:

LABORATOIRE RIVA INC.

Koda artikla:

J02AC01

INN (mednarodno ime):

FLUCONAZOLE

Odmerek:

100MG

Farmacevtska oblika:

TABLET

Sestava:

FLUCONAZOLE 100MG

Pot uporabe:

ORAL

Enote v paketu:

50

Tip zastaranja:

Prescription

Terapevtsko območje:

AZOLES

Povzetek izdelek:

Active ingredient group (AIG) number: 0122529002; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2016-05-31

Lastnosti izdelka

PRODUCT MONOGRAPH
RIVA-FLUCONAZOLE
(Fluconazole)
100 mg Tablets
Antifungal Agent
LABORATOIRE RIVA INC.
Date of Preparation:
660 Boul. Industriel
September 13, 2005
Blainville, Quebec
J7C 3V4
Date of Revision: N/A
Control#: 101062
1
PRODUCT MONOGRAPH
RIVA-FLUCONAZOLE
(Fluconazole)
100 mg Tablets
THERAPEUTIC CLASSIFICATION
Antifungal Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Fluconazole is a highly selective inhibitor of fungal cytochrome P-450
sterol C-14-
"
-demethylation.
Mammalian cell demethylation is much less sensitive to fluconazole
inhibition. The subsequent loss
of normal sterols correlates with the accumulation of 14-
"
-methyl sterols in fungi and may be
responsible for the fungistatic activity of fluconazole.
A study was performed, comparing RIVA-Fluconazole against the Canadian
Reference Product
Diflucan™. The study was a comparative, randomized, single-dose,
2-way crossover bioavailability
study of 100 mg fluconazole tablets, following administration of a 200
mg dose under fasting
conditions. The pharmacokinetic data are presented below.
2
SUMMARY TABLE OF THE COMPARATIVE BIOAVAILABILITY DATA FOR SINGLE
DOSE STUDIES
Fluconazole
100 mg
From measured and log transformed data
uncorrected for potency
Geometric Mean
Arithmetic Mean (CV%)
PARAMETER
TEST
REFERENCE
(Diflucan™)
% RATIO OF
GEOMETRIC
MEANS
90%
CONFIDENCE
INTERVAL
AUC
0-72
(mcg.h/mL)
126.84
128.3 (15.4%)
125.35
126.6 (13.7%)
101.2%
98.9 - 103.6 %
AUC
inf
(mcg.h/mL)
175.70
179.9 (22.1%)
177.06
180.4 (18.5%)
99.2%
94.7 - 104.0 %
C
MAX
(mcg/mL)
3.92741
3.9944 (18.4%)
3.74061
3.7912 (16.4%)
105.0%
100.2 - 110.0 %
t
MAX
*
(h)
1.326 (49.0%)
1.630 (60.1%)
N/AP
N/AP
t
½
*
(h)
40.44 (20.4%)
42.41 (18.7%)
N/AP
N/AP
INDICATIONS AND CLINICAL USE
Treatment
RIVA-FLUCONAZOLE (fluconazole) is indicated for the treatment of:
1.
Oropharyngeal and esophageal candidiasis. RIVA-FLUCONAZOLE is also
effective for the
treatment of serious systemic
candidal infections,
including urinary tract
infection,
peritonitis, and pneumonia.
2.
Cryptococcal meningitis.
3.
Preve