FUNZOL 150/MG CAP 1/CAP

Indications

Approved Uses

Treatment of mucosal candidiasis (oropharyngeal and esophageal), vaginal candidiasis, systemic Candida infections (including candidemia/disseminated candidiasis), cryptococcal meningitis, and prophylaxis of fungal/Candida infections in immunocompromised patients (e.g., bone marrow transplant); other Candida infections may be treated per susceptibility and clinical context.

Off-Label Uses

Common off-label uses include tinea versicolor, dermatophytosis (tinea corporis/cruris/pedis), onychomycosis, and endemic mycoses such as coccidioidomycosis and histoplasmosis/blastomycosis in selected scenarios; neonatal Candida prophylaxis is also used in some protocols.

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 for ≥2 weeks after symptom resolution. Cryptococcal meningitis: 400 mg PO on day 1 then 200-400 mg PO daily for 10-12 weeks (often longer depending on host factors). Systemic candidiasis/candidemia: typically 800 mg (12 mg/kg) loading then 400 mg (6 mg/kg) daily when fluconazole is appropriate based on species/susceptibility and clinical stability. Prophylaxis in high-risk immunocompromised: 50-400 mg PO daily depending on risk and indication.

Initial Dose

150mg as a single dose (vaginal candidiasis).

Maintenance Dose

100-400 mg once daily, depending on the indication.

Maximum Dose

Doses up to 800mg daily have been used for severe infections.

Children's Dosage

Oropharyngeal candidiasis: 3mg/kg once daily (max 100mg/day). Systemic candidiasis/cryptococcal meningitis: 6-12mg/kg once daily (max 400mg/day). Not recommended in neonates under 4 weeks except in life-threatening situations

Dose Adjustment Notes

Renal impairment: reduce maintenance dose when CrCl ≤50 mL/min (commonly 50% of usual maintenance); give the full scheduled dose after hemodialysis on dialysis days. Hepatic impairment: no specific adjustment, but use caution and monitor LFTs.

How to Take

Swallow the 150 mg capsule whole with water; may be taken with or without food.

Side Effects

Common Side Effects

Headache, Diarrhea, Nausea, Abdominal pain, Dizziness, Changes in taste, Vomiting, Elevated liver enzymes.

Side Effect Frequency

Common (≥1%): headache, nausea, abdominal pain, diarrhea, rash; Uncommon (0.1-1%): vomiting, dyspepsia, dizziness, taste disturbance, ALT/AST increases; Rare/very rare (<0.1%): serious hepatotoxicity, Stevens-Johnson syndrome/TEN, anaphylaxis/angioedema, QT prolongation/torsades, seizures, severe blood dyscrasias.

Safety & Warnings

Contraindications

Hypersensitivity to fluconazole/other azoles; co-administration with QT-prolonging CYP3A4 substrates such as cisapride, astemizole, pimozide, quinidine, and erythromycin; terfenadine is contraindicated with fluconazole at doses ≥400 mg/day.

Warnings & Precautions

Use caution and monitor in hepatic disease (stop if hepatotoxicity), renal impairment (dose adjust), and patients with QT-prolongation risk factors/electrolyte abnormalities; discontinue if severe rash occurs; avoid prolonged/high-dose use in pregnancy due to fetal risk.

Age Restriction

No fixed minimum age; fluconazole is used in pediatrics (including neonates) with age/weight-based dosing under specialist supervision-this 150 mg single capsule is generally an adult formulation and not suitable for small children.

Drug Interactions

Drug Interactions

Major interactions include warfarin (↑INR), sulfonylureas (↑hypoglycemia), phenytoin (↑levels), cyclosporine/tacrolimus (↑levels), rifampin (↓fluconazole), theophylline (↑levels), benzodiazepines such as midazolam/triazolam (↑sedation), CYP3A4 statins (↑myopathy/rhabdo risk), and QT-prolonging agents-some are contraindicated (cisapride/astemizole/pimozide/quinidine/erythromycin; terfenadine at ≥400 mg/day).

Interaction Severity

MAJOR/contraindicated or avoid: cisapride, pimozide, quinidine, (and other QT-prolonging substrates such as erythromycin in some labeling) due to torsades/QT risk; high-dose terfenadine is contraindicated and terfenadine should be avoided. MAJOR/clinically significant: warfarin (↑INR/bleeding), tacrolimus/cyclosporine (↑levels/toxicity). MODERATE: phenytoin (↑levels), sulfonylureas (hypoglycemia), certain statins (esp. simvastatin/lovastatin-myopathy/rhabdo risk), benzodiazepines (e.g., midazolam/triazolam-prolonged sedation), rifampicin (↓fluconazole exposure).

Food Interaction

No food restriction; can be taken with or without food.

Special Populations

Children

Oropharyngeal candidiasis: 3mg/kg once daily (max 100mg/day). Systemic candidiasis/cryptococcal meningitis: 6-12mg/kg once daily (max 400mg/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 (not on dialysis): give 50% of the usual dose (after any loading dose); hemodialysis: give the full dose after each dialysis session.

Storage & Patient Advice

Missed Dose

If on a multi-day regimen: take the missed dose as soon as remembered unless it is close to the next dose; do not double. If prescribed as a single 150 mg dose, take it as soon as possible on the same day and contact the prescriber if substantially delayed or symptoms persist.

Stopping the Medicine

Take exactly as prescribed; for single-dose indications (e.g., uncomplicated vulvovaginal candidiasis) no “course completion” applies-do not repeat/extend without prescriber advice.

Overdose

Overdose may cause hallucinations/paranoid behavior and GI symptoms; manage with supportive care ± gastric lavage if early; hemodialysis enhances elimination (about 50% removed in ~3 hours).

Patient Counseling

Take exactly as prescribed (often a single 150 mg capsule for uncomplicated vaginal thrush); may take with or without food. Expect improvement within 24-72 hours; seek medical advice if not improving, recurrent, or severe. Review all medicines for interactions (notably warfarin, some statins, sulfonylureas, antiepileptics, calcineurin inhibitors, and QT-risk drugs). Seek urgent care for rash/blistering, jaundice/dark urine, severe abdominal pain, or palpitations/syncope. Pregnancy: avoid self-treatment and consult a clinician (systemic fluconazole is generally avoided in pregnancy unless clearly indicated). Store below 25°C.

Monitoring Requirements

Monitor liver function tests with prolonged therapy or if hepatic disease/symptoms occur; monitor renal function for dose adjustment; consider ECG/QT monitoring in patients with risk factors or when combined with QT-prolonging drugs; monitor INR closely if co-administered with warfarin.

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.

Onset of Action

Peak plasma concentrations occur ~1-2 hours after oral dosing; symptom improvement for vulvovaginal candidiasis often begins within ~24 hours, with continued improvement over 48-72 hours.

Duration of Effect

Elimination half-life is ~30 hours; after a single 150 mg dose, therapeutic exposure persists for several days (often ~72 hours), supporting single-dose therapy for uncomplicated vulvovaginal candidiasis.

Half-Life

Approximately 30 hours (range: 20-50 hours).

Bioavailability

Oral bioavailability >90%.

Metabolism

Minimal hepatic metabolism (about 10-12%); most of the drug is excreted unchanged; fluconazole is a CYP2C9 and CYP2C19 inhibitor and a moderate CYP3A4 inhibitor.

Excretion

Primarily renal; ~80% of the dose is excreted unchanged in urine.

Protein Binding

11-12%.

Product Information

Available Dosage Forms

Tablet, Capsule, Oral suspension, Injection for intravenous infusion.

Composition per Dose

Each capsule: 150mg fluconazole

Generic Availability

Yes

OTC Alternatives

For vulvovaginal candidiasis, OTC topical azoles (e.g., clotrimazole or miconazole vaginal products) are alternatives; for oral thrush, OTC options are generally not appropriate-treatment is typically prescription (topical nystatin or miconazole oral gel where available/regulated).

Application

Oral

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