TEVA-FLUCONAZOLE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUCONAZOLE

Available from:

TEVA CANADA LIMITED

ATC code:

J02AC01

INN (International Name):

FLUCONAZOLE

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

FLUCONAZOLE 100MG

Administration route:

ORAL

Units in package:

50/100/500/1000

Prescription type:

Prescription

Therapeutic area:

AZOLES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2002-06-06

Summary of Product characteristics

TEVA-FLUCONAZOLE
(
Fluconazole Tablets
)
Page 1 of 53
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-FLUCONAZOLE
Fluconazole Tablets
Tablets, 50 mg and 100 mg, Oral
Teva Standard
Antifungal Agent
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control Number: 274570
Date of Initial Authorization:
August 24, 2016
Date of Revision:
June 20, 2023
TEVA-FLUCONAZOLE
(
Fluconazole Tablets
)
Page 2 of 53
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
11/2022
9
DRUG INTERACTIONS
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I:
HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics(<18 years of age)
............................................................................................
4
1.2
Geriatrics
..........................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
.....................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................................ 5
4.4
Missed Dose
............................................................................................................