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APO-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: APO-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 APO-FLUCONAZOLE-150 for vaginal candidiasis is 150 mg as a single oral dose. APO-FLUCONAZOLE-150 (Fluconazole Capsules) Page 5 of 37 • 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
3 Pediatrics). 2 CONTRAINDICATIONS • APO-FLUCONAZOLE-150 is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of the excipients used. See the 6 DOSAGE FORMS, STRENGTHS, 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 astemizole* is contraindicated in patients receiving fluconazole (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).
2 Recommended Dose and Dosage Adjustment • The recommended dosage of APO-FLUCONAZOLE-150 for vaginal candidiasis is 150 mg as a single oral dose. APO-FLUCONAZOLE-150 (Fluconazole Capsules) Page 5 of 37 • There is no need to adjust single-dose therapy for vaginal candidiasis because of impaired renal function.
5 OVERDOSAGE Symptoms: There have been reports of overdosage with fluconazole and in one reported case, a 42-year-old patient infected with human immunodeficiency virus developed hallucinations and exhibited paranoid behaviour after reportedly ingesting 8200 mg of fluconazole.
The patient was admitted to the hospital, and his condition resolved within 48 hours.
09/2022 9 DRUG INTERACTIONS 04/2023 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 ................................................................................................................. 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ......................................
5 7 WARNINGS AND PRECAUTIONS ...................................................................................... 1 Special Populations ......................................................................................................
1 Pregnant Women ......................................................................................................... 2 Breast-feeding .............................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment:
In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate. Fluconazole is largely excreted in urine. A 3-hour hemodialysis session decreases plasma levels by approximately 50%.
Mice and rats receiving very high doses of fluconazole, whether orally or intravenously, displayed a variety of nonspecific, agonal signs such as decreased activity, ataxia, shallow respiration, ptosis, lacrimation, salivation, urinary incontinence and cyanosis.
Death was sometimes preceded by clonic convulsions. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Capsule, 150 mg Colloidal silicon dioxide, croscarmellose sodium, gelatin, lactose monohydrate, microcrystalline cellulose, pharmaceutical ink, stearic acid, talc and titanium dioxide.
APO-FLUCONAZOLE-150 capsule is available as a hard, white, opaque, gelatin capsule, imprinted with APO F150. Each capsule contains 150 mg of fluconazole. Supplied as a unit dose blister pack of 1 capsule. 7 WARNINGS AND PRECAUTIONS General APO-FLUCONAZOLE-150 is indicated for single dose only.
Some (not all) adverse experiences have been reported in patients following exposure to multiple doses of fluconazole. APO-FLUCONAZOLE-150 (Fluconazole Capsules) Page 6 of 37 The convenience of the single oral dose fluconazole regimen for the treatment of vaginal yeast infections should be weighed against the acceptability of a higher incidence of drug related adverse events with oral fluconazole (26%) versus intravaginal agents (16%) in comparative clinical studies where no difference in efficacy was demonstrated (see
3 Pediatrics ...................................................................................................................... 8 8 ADVERSE REACTIONS ......................................................................................................
2 Clinical Trial Adverse Reactions ................................................................................... 3 Less Common Clinical Trial Adverse Reactions ............................................................ 5 Post-Market Adverse Reactions ...................................................................................
9 9 DRUG INTERACTIONS .................................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions .............................................................................................. 6 Drug-Herb Interactions ..............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................. 16 10 CLINICAL PHARMACOLOGY ...........................................................................................
1 Mechanism of Action ................................................................................................. 2 Pharmacodynamics ....................................................................................................
3 Pharmacokinetics ....................................................................................................... 17 11 STORAGE, STABILITY AND DISPOSAL .............................................................................
19 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 19 PART II: SCIENTIFIC INFORMATION ......................................................................................
20 13 PHARMACEUTICAL INFORMATION ................................................................................ 20 14 CLINICAL TRIALS ............................................................................................................
1 Trial Design and Study Demographics ...................................................................... 2 Study Results ..............................................................................................................
3 Comparative Bioavailability Studies........................................................................... 23 15 MICROBIOLOGY ............................................................................................................
23 16 NON-CLINICAL TOXICOLOGY ......................................................................................... 26 17 SUPPORTING PRODUCT MONOGRAPHS ....................................................................... 31 PATIENT MEDICATION INFORMATION .................................................................................
32 APO-FLUCONAZOLE-150 (Fluconazole Capsules) Page 4 of 37 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-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 APO-FLUCONAZOLE-150 in pediatric patients has been established. 3 Pediatrics). 2 CONTRAINDICATIONS • APO-FLUCONAZOLE-150 is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of the excipients used.
See the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph for a complete listing of excipients. […]