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RIVA-FLUCONAZOLE is a brand name for Fluconazole, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: RIVA-FLUCONAZOLE (fluconazole) is indicated for the single-dose treatment of vaginal candidiasis (yeast infections due to Candida) and is clinically proven to cure most vaginal yeast infections. 1.1 Pediatrics Pediatrics (>12 years of age): Based on the data submitted and reviewed by Health Canada, the safety and…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment • The recommended dosage of RIVA-FLUCONAZOLE for vaginal candidiasis is 150 mg as a single oral dose. • There is no need to adjust single-dose therapy for vaginal candidiasis because of impaired renal function.
RIVA-FLUCONAZOLE (fluconazole) – Product Monograph Page 5 of 33
). Fluconazole administered in combination with ethinyl estradiol- and levonorgestrel-containing oral contraceptives produced an overall mean increase in ethinyl estradiol and levonorgestrel levels; however, in some patients there were decreases up to 47% and 33% of ethinyl estradiol and levonorgestrel levels, respectively (See
01/2023 9 DRUG INTERACTIONS 02/2024 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 .............................................................................................................. 1 Pediatrics.................................................................................................................
4 2 CONTRAINDICATIONS................................................................................................. 4 4 DOSAGE AND ADMINISTRATION................................................................................. 2 Recommended Dose and Dosage Adjustment .......................................................
4 5 OVERDOSAGE............................................................................................................. 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS ..................................................................................
1 Special Populations ................................................................................................. 1 Pregnant Women ................................................................................................
2 Breast-feeding ..................................................................................................... 3 Pediatrics.............................................................................................................
01/2023 7 WARNINGS AND PRECAUTIONS 01/2023 9 DRUG INTERACTIONS 02/2024 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 .............................................................................................................. 1 Pediatrics.................................................................................................................
4 2 CONTRAINDICATIONS................................................................................................. 4 4 DOSAGE AND ADMINISTRATION................................................................................. 2 Recommended Dose and Dosage Adjustment .......................................................
4 5 OVERDOSAGE............................................................................................................. 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS ..................................................................................
1 Special Populations ................................................................................................. 1 Pregnant Women ................................................................................................
2 Breast-feeding ..................................................................................................... 3 Pediatrics.............................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fluconazole in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
7 8 ADVERSE REACTIONS.................................................................................................. 2 Clinical Trial Adverse Reactions ..............................................................................
3 Less Common Clinical Trial Adverse Reactions ....................................................... 5 Post-Market Adverse Reactions.............................................................................. 8 9 DRUG INTERACTIONS .................................................................................................
4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ......................................................................................... 6 Drug-Herb Interactions .........................................................................................
7 Drug-Laboratory Test Interactions........................................................................ 14 RIVA-FLUCONAZOLE (fluconazole) – Product Monograph Page 3 of 33 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ............................................................................................ 2 Pharmacodynamics ............................................................................................... 3 Pharmacokinetics ..................................................................................................
15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 16 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 16 PART II: SCIENTIFIC INFORMATION ......................................................................................
17 13 PHARMACEUTICAL INFORMATION ........................................................................... 17 14 CLINICAL TRIALS .......................................................................................................
1 Trial Design and Study Demographics .................................................................. 2 Study Results ......................................................................................................... 3 Comparative Bioavailability Studies .....................................................................
20 15 MICROBIOLOGY ....................................................................................................... 21 16 NON-CLINICAL TOXICOLOGY .....................................................................................
23 17 SUPPORTING PRODUCT MONOGRAPHS.................................................................... 27 PATIENT MEDICATION INFORMATION ................................................................................. 28 RIVA-FLUCONAZOLE (fluconazole) – Product Monograph Page 4 of 33 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS RIVA-FLUCONAZOLE (fluconazole) is indicated for the single-dose treatment of vaginal candidiasis (yeast infections due to Candida) and is clinically proven to cure most vaginal yeast infections.
1 Pediatrics Pediatrics (>12 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of fluconazole in pediatric patients has been established. 3 Pediatrics). 2 CONTRAINDICATIONS • RIVA-FLUCONAZOLE (fluconazole) is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of the excipients used.
See the 6 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph for a complete listing of excipients. There is no information regarding cross hypersensitivity between fluconazole and other azole antifungal agents.
Caution should be used by individuals having hypersensitivity to […]
7 8 ADVERSE REACTIONS.................................................................................................. 2 Clinical Trial Adverse Reactions ..............................................................................
3 Less Common Clinical Trial Adverse Reactions ....................................................... 5 Post-Market Adverse Reactions.............................................................................. 8 9 DRUG INTERACTIONS .................................................................................................
4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ......................................................................................... 6 Drug-Herb Interactions .........................................................................................
7 Drug-Laboratory Test Interactions........................................................................ 14 RIVA-FLUCONAZOLE (fluconazole) – Product Monograph Page 3 of 33 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ............................................................................................ 2 Pharmacodynamics ............................................................................................... 3 Pharmacokinetics ..................................................................................................
15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 16 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 16 PART II: SCIENTIFIC INFORMATION ......................................................................................
17 13 PHARMACEUTICAL INFORMATION ........................................................................... 17 14 CLINICAL TRIALS .......................................................................................................
1 Trial Design and Study Demographics .................................................................. 2 Study Results ......................................................................................................... 3 Comparative Bioavailability Studies .....................................................................
20 15 MICROBIOLOGY ....................................................................................................... 21 16 NON-CLINICAL TOXICOLOGY .....................................................................................
23 17 SUPPORTING PRODUCT MONOGRAPHS.................................................................... 27 PATIENT MEDICATION INFORMATION ................................................................................. 28 RIVA-FLUCONAZOLE (fluconazole) – Product Monograph Page 4 of 33 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS RIVA-FLUCONAZOLE (fluconazole) is indicated for the single-dose treatment of vaginal candidiasis (yeast infections due to Candida) and is clinically proven to cure most vaginal yeast infections.
1 Pediatrics Pediatrics (>12 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of fluconazole in pediatric patients has been established. 3 Pediatrics). 2 CONTRAINDICATIONS • RIVA-FLUCONAZOLE (fluconazole) is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of the excipients used.
See the 6 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph for a complete listing of excipients. There is no information regarding cross hypersensitivity between fluconazole and other azole antifungal agents.
Caution should be used by […]