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BIO-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: Bio-FLUCONAZOLE (fluconazole) is indicated for the single-dose treatment of vaginal candidiasis (yeastinfections 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 Bio-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.
Bio-FLUCONAZOLE (fluconazole) – Product Monograph Page 5 of 35 1.
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 thehospital, and his condition resolved within 48 hours.
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. 2. 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 anhydrous silica, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium lauryl sulphate.
Capsule shell contains: gelatin, and titanium dioxide. Each capsule contains 150 mg of fluconazole. Supplied as a unit dose blister pack of 1 capsule.
Composition:
Bio-FLUCONAZOLE: Each capsule (white) contains 150 mg fluconazole.
The capsule also contains the following non-medicinal ingredients:
Colloidal anhydrous silica, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium lauryl sulphate; the capsule shell contains gelatin and titanium dioxide. For management of a suspected drug overdose, contact your regional poison control center.
). 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 • Bio-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 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 Bio-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.
Bio-FLUCONAZOLE (fluconazole) – Product Monograph Page 5 of 35 1.
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 thehospital, and his condition resolved within 48 hours.
• Bio-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 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).
*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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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.
Bio-FLUCONAZOLE (fluconazole) – Product Monograph Page 6 of 35 3. WARNINGS AND PRECAUTIONS General Bio-FLUCONAZOLE (fluconazole) is indicated for single dose only. Some (not all) adverse experiences have been reported in patients following exposure to multiple doses of fluconazole.
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 8 ADVERSE REACTIONS).
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 9 DRUG INTERACTIONS).
The data presently available indicate that the decreases in some individual ethinyl estradiol and levonorgestrel AUC values with fluconazole treatment may be the result of random variation. While there is evidence that fluconazole can inhibit the metabolism of ethinyl estradiol and levonorgestrel, there is no evidence that fluconazole is a net inducer of ethinyl estradiol or levonorgestrel metabolism.
The clinical significance of these effects is presently unknown.
Cardiovascular QT Prolongation:
Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and Torsade de Pointes in patients taking fluconazole.
These reports included seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities and concomitant medications that may have been contributory. Fluconazole should be administered with caution to patients with these potentially proarrhythmic conditions (see 9 DRUG INTERACTIONS AND 8 ADVERSE EFFECTS).
, ketoconazole). Reversible cases of adrenal insufficiency were reported in patients receiving fluconazole or when fluconazole was discontinued (see 9 DRUG INTERACTIONS). Hepatic/Biliary/Pancreatic In the treatment of systemic infections, multiple doses of fluconazole have been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions.
In cases of fluconazole-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex or age of the patient has been observed. Fluconazole hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy.
Immune In rare cases, anaphylaxis and angioedema have been reported in patients using fluconazole. Bio-FLUCONAZOLE (fluconazole) – Product Monograph Page 7 of 35 Sensitivity/Resistance Candidiasis: Studies have shown an increasing prevalence of infections with Candida species other than C.
albicans. , C. krusei and C. auris) or show reduced susceptibility to fluconazole (C. glabrata). Such infections may require alternative antifungal therapy secondary to treatment failure. Therefore, prescribers are advised to take into account the prevalence of resistance in various Candida species to fluconazole (see 15 MICROBIOLOGY).
Skin In very rare cases, during the treatment of systemic and vaginal infections, patients have developed exfoliative skin disorders […]
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. 2. 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 anhydrous silica, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium lauryl sulphate.
Capsule shell contains: gelatin, and titanium dioxide. Each capsule contains 150 mg of fluconazole. Supplied as a unit dose blister pack of 1 capsule.
Composition:
Bio-FLUCONAZOLE: Each capsule (white) contains 150 mg fluconazole.
The capsule also contains the following non-medicinal ingredients:
Colloidal anhydrous silica, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium lauryl sulphate; the capsule shell contains gelatin and titanium dioxide. For management of a suspected drug overdose, contact your regional poison control center.
Bio-FLUCONAZOLE (fluconazole) – Product Monograph Page 6 of 35 3. WARNINGS AND PRECAUTIONS General Bio-FLUCONAZOLE (fluconazole) is indicated for single dose only. Some (not all) adverse experiences have been reported in patients following exposure to multiple doses of fluconazole.
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