CANDIVAST 50/MG CAP 7/CAP

Indications

Approved Uses

Mucosal candidiasis (oropharyngeal and esophageal), vaginal candidiasis, systemic Candida infections (including candidemia/disseminated candidiasis), cryptococcal meningitis, and prophylaxis of Candida infections in high-risk immunocompromised patients (e.g., transplant/chemotherapy).

Off-Label Uses

Examples of off-label/less commonly labeled uses include coccidioidomycosis and other endemic mycoses in selected scenarios, Candida urinary tract infection (when susceptible and systemic therapy is needed), and suppression/prevention of recurrent vulvovaginal candidiasis (maintenance regimens).

Dosage & Administration

Dosing by Condition

Vaginal candidiasis: 150 mg PO once. Oropharyngeal candidiasis: 200 mg PO on day 1 then 100 mg PO daily for at least 7-14 days. Esophageal candidiasis: 200 mg PO on day 1 then 100 mg PO daily (may increase to 200-400 mg daily) for at least 3 weeks and ≥2 weeks after symptom resolution. Cryptococcal meningitis (consolidation/maintenance after induction): typically 400 mg daily then 200 mg daily for a prolonged duration (often ≥8 weeks consolidation then maintenance), per guideline phase-based therapy. Systemic candidemia/invasive candidiasis (step-down when appropriate): 800 mg (12 mg/kg) loading then 400 mg (6 mg/kg) daily, with duration guided by source control and clinical response.

Initial Dose

200mg loading dose on day 1 for most systemic infections; 150mg single dose for vaginal candidiasis

Maintenance Dose

100-200mg once daily for most indications (excluding single-dose vaginal candidiasis).

Maximum Dose

Up to 800 mg/day may be used for severe/life-threatening systemic fungal infections under specialist supervision; many common indications use ≤400 mg/day.

Children's Dosage

3mg/kg/day for oropharyngeal candidiasis (max 100mg/day); 6mg/kg/day for systemic infections (max 400mg/day); 12mg/kg/day for severe infections (max 600mg/day). Not recommended in neonates under 4 weeks except in life-threatening situations

Dose Adjustment Notes

Renal adjustment is required: for multiple-dose therapy, give a normal loading dose then reduce maintenance dose by ~50% when CrCl ≤50 mL/min (not on dialysis); administer the full scheduled dose after each hemodialysis session; use caution and monitor in hepatic disease.

How to Take

Swallow the capsule whole with water; may be taken with or without food; if prescribed as a multi-dose regimen, take at the same time each day.

Side Effects

Common Side Effects

Headache, Nausea, Abdominal pain, Diarrhea, Vomiting, Rash, Dizziness, Increased liver enzymes.

Safety & Warnings

Contraindications

Contraindicated in hypersensitivity to fluconazole/other azoles; contraindicated with coadministration of cisapride, astemizole, pimozide, quinidine, or erythromycin; terfenadine is contraindicated when fluconazole is used at multiple doses ≥400 mg/day.

Warnings & Precautions

Use caution and monitor in hepatic dysfunction (stop if hepatotoxicity develops), renal impairment (dose adjust), and patients with QT-prolongation risk/electrolyte abnormalities or on QT-prolonging drugs; discontinue if severe rash/SCAR suspected.

Age Restriction

Can be used in children (including neonates) with age- and weight-based dosing; in neonates dosing interval is extended (e.g., every 72 hours in the first 2 weeks, every 48 hours in weeks 2-4).

Drug Interactions

Drug Interactions

Major/contraindicated: cisapride, astemizole, pimozide, quinidine, erythromycin; dose-dependent with terfenadine (≥400 mg/day). Clinically significant: warfarin (↑INR/bleeding), phenytoin (↑levels), cyclosporine/tacrolimus (↑levels/nephrotoxicity), sulfonylureas (↑hypoglycemia), benzodiazepines such as midazolam/triazolam (↑sedation), theophylline (↑levels), rifampicin (↓fluconazole exposure), CYP3A4 statins (↑myopathy/rhabdo risk), hydrochlorothiazide (↑fluconazole levels), zidovudine (↑AZT adverse effects), and additive risk with other QT-prolonging drugs.

Interaction Severity

MAJOR/contraindicated or avoid: cisapride, pimozide, quinidine, and (where applicable) erythromycin due to QT prolongation/torsades risk; terfenadine/astemizole are also classically listed where still relevant. MODERATE/clinically significant: warfarin (↑INR/bleeding), phenytoin (↑levels), cyclosporine/tacrolimus/sirolimus (↑levels/nephrotoxicity), sulfonylureas (hypoglycemia), certain statins (myopathy/rhabdo), benzodiazepines (e.g., midazolam/triazolam; ↑sedation), theophylline (↑levels).

Food Interaction

No clinically significant food interaction; may be taken with or without food.

Special Populations

Children

3mg/kg/day for oropharyngeal candidiasis (max 100mg/day); 6mg/kg/day for systemic infections (max 400mg/day); 12mg/kg/day for severe infections (max 600mg/day). Not recommended in neonates under 4 weeks except in life-threatening situations

Kidney Impairment

If CrCl >50 mL/min: no adjustment; if CrCl ≤50 mL/min (and not on dialysis): give 50% of the usual maintenance dose after any loading dose; hemodialysis: give the full dose after each dialysis session.

Storage & Patient Advice

Stopping the Medicine

Do not stop early without prescriber advice; complete the prescribed course unless significant adverse effects occur.

Patient Counseling

Take exactly as prescribed; may take with or without food and swallow capsule whole. If on a course, complete it; report rash/blistering, jaundice/dark urine, severe abdominal pain, or persistent nausea. Avoid new medications (including OTC/herbals) without checking due to interactions (especially warfarin, antidiabetics, transplant meds). May cause dizziness-use caution driving if affected. Discuss pregnancy/breastfeeding; avoid high-dose/prolonged use in pregnancy unless clearly directed.

Monitoring Requirements

Monitor liver function tests if prolonged therapy or underlying liver disease; monitor renal function for dosing (especially in renal impairment); monitor INR/prothrombin time if on warfarin; consider ECG/QT risk assessment when combined with QT-prolonging drugs or in high-risk patients; monitor for rash/SCAR symptoms.

Pharmacology

Mechanism of Action

Inhibits fungal CYP450-dependent lanosterol 14-α-demethylase, blocking conversion of lanosterol to ergosterol and impairing fungal cell membrane synthesis and function (primarily fungistatic).

Onset of Action

Peak plasma concentrations occur about 1-2 hours after oral dosing; clinical improvement is typically seen within 24-72 hours depending on infection site and severity.

Duration of Effect

Once-daily dosing is supported by a long elimination half-life of about 30 hours (range ~20-50 hours).

Half-Life

Approximately 30 hours (range 20-50 hours).

Metabolism

Fluconazole undergoes minimal hepatic metabolism (approximately 10-12% of a dose); it is primarily eliminated renally as unchanged drug, and it is a clinically relevant inhibitor of CYP2C9 and CYP2C19 and a moderate inhibitor of CYP3A4.

Excretion

Primarily renal; about 80% excreted unchanged in urine.

Protein Binding

11-12%.

Product Information

Available Dosage Forms

Capsule, Tablet, Oral suspension, Intravenous injection, Oral solution

Composition per Dose

Each capsule: 50mg fluconazole

Application

Oral

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