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NRA-FLUCONAZOLE-150 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: NRA-FLUCONAZOLE-150 (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 NRA-FLUCONAZOLE-150 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.
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
09/2022 DRUG INTERACTIONS 05/2023 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 ............................................................................................................... 1 Pediatrics ................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 2 Recommended Dose and Dosage Adjustment .......................................................
4 5 OVERDOSAGE.............................................................................................................. 4 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.................................. 5 7 WARNINGS AND PRECAUTIONS...................................................................................
1 Special Populations ................................................................................................ 1 Pregnant Women.............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics .......................................................................................................... 7 8 ADVERSE REACTIONS ..................................................................................................
• NRA-FLUCONAZOLE-150 (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 other azoles when using fluconazole. • Co-administration of terfenadine* is contraindicated in patients receiving fluconazole at multiple doses of 400 mg/day or higher based upon results of a multiple-dose interaction study (see 9 DRUG INTERACTIONS).
• Co-administration of cisapride* is contraindicated in patients receiving fluconazole (see 9 DRUG INTERACTIONS). • Co-administration of drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as amiodarone, erythromycin, pimozide and quinidine are contraindicated in patients receiving fluconazole (see 9 DRUG INTERACTIONS).
*not marketed in Canada
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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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 NRA--FLUCONAZOLE-150 (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…………………………………………………………………. 28 PATIENT MEDICATION INFORMATION .................................................................................. 29 NRA-FLUCONAZOLE-150 (fluconazole) – Product Monograph Page 4 of 33 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS NRA-FLUCONAZOLE-150 (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 • NRA-FLUCONAZOLE-150 (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 other azoles when using fluconazole. • Co-administration of terfenadine* is contraindicated in patients […]