FLOCAZOLE 150/MG CAP 1/CAP

Indications

Approved Uses

Fluconazole is indicated for mucosal candidiasis (oropharyngeal and esophageal), vulvovaginal candidiasis, systemic Candida infections (including candidemia/disseminated candidiasis), cryptococcal meningitis, Candida urinary tract infections/peritonitis, and prophylaxis of Candida infections in high-risk immunocompromised patients (e.g., bone marrow transplant).

Off-Label Uses

Off-label/less common uses include endemic mycoses (e.g., coccidioidomycosis; sometimes histoplasmosis/blastomycosis when alternatives unsuitable), dermatophyte infections/tinea versicolor in selected cases, and antifungal prophylaxis in certain neonatal/high-risk populations per institutional protocols.

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis: 150 mg PO once.

Initial Dose

150mg as a single dose (vaginal candidiasis)

Maintenance Dose

Not applicable for this single-dose 150mg capsule formulation.

Maximum Dose

This product’s usual single-dose regimen is 150 mg once.

Children's Dosage

Not recommended for this 150mg capsule formulation.

Dose Adjustment Notes

Renal impairment: for single-dose vulvovaginal candidiasis (150 mg once), no dose adjustment is needed; for multiple-dose regimens, if CrCl ≤50 mL/min (not on dialysis) give 50% of the usual maintenance dose after a normal loading dose; hemodialysis: give 100% of the dose after each dialysis session. Hepatic impairment: no specific adjustment, but use caution and monitor LFTs.

How to Take

Swallow capsule whole with a glass of water; can be taken with or without food

Side Effects

Common Side Effects

Headache, nausea, abdominal pain, diarrhea, vomiting, rash, dizziness, dyspepsia, flatulence

Side Effect Frequency

Common (≥1% to <10%): headache, nausea, abdominal pain, diarrhea, rash, increased liver enzymes; Uncommon (≥0.1% to <1%): vomiting, dyspepsia, dizziness; Rare (<0.1%): seizures, alopecia, anaphylaxis, Stevens-Johnson syndrome/toxic epidermal necrolysis, severe hepatotoxicity/hepatic failure, QT prolongation/torsades de pointes, blood dyscrasias (e.g., leukopenia, thrombocytopenia).

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to fluconazole/other azoles; concomitant use with CYP3A4-substrate drugs known to prolong QT and associated with torsades risk (cisapride, astemizole, pimozide, quinidine, erythromycin); and terfenadine when fluconazole is used at multiple doses ≥400 mg/day.

Warnings & Precautions

Use caution/monitor in hepatic dysfunction (stop if hepatotoxicity), renal impairment (dose adjust), and patients with QT-risk/proarrhythmic conditions or interacting QT-prolonging drugs; discontinue if severe rash/SCAR suspected; rare adrenal insufficiency with prolonged use; consider cross-hypersensitivity with other azoles.

Drug Interactions

Drug Interactions

Major/contraindicated: cisapride, astemizole, pimozide, quinidine, erythromycin; terfenadine with multiple doses ≥400 mg/day. Clinically important interactions requiring monitoring/adjustment: warfarin (↑INR/bleeding), sulfonylureas (↑hypoglycemia), phenytoin (↑levels), cyclosporine/tacrolimus (↑levels/nephrotoxicity), rifampicin (↓fluconazole), benzodiazepines such as midazolam/triazolam (↑sedation), CYP3A4 statins (↑myopathy/rhabdo), theophylline (↑levels), hydrochlorothiazide (↑fluconazole), zidovudine (↑AZT adverse effects).

Interaction Severity

MAJOR/contraindicated (QT/TdP risk): cisapride, pimozide, quinidine, erythromycin; also avoid with other high-risk QT-prolonging agents where contraindicated by labeling. MODERATE/clinically significant: warfarin (↑INR), sulfonylureas (hypoglycemia), phenytoin (↑levels), cyclosporine/tacrolimus (↑levels/nephrotoxicity), certain statins (myopathy/rhabdo risk), benzodiazepines (↑sedation), and rifampin (↓fluconazole exposure).

Food Interaction

No restriction. [7, 29]

Special Populations

Pregnancy

Category D

Breastfeeding

Safe

Children

Not recommended for this 150mg capsule formulation.

Elderly

Standard adult dosing; adjust for renal function as renal clearance may be reduced in elderly patients

Kidney Impairment

If CrCl >50 mL/min: usual dose; if CrCl ≤50 mL/min (no dialysis): give a loading dose then 50% of the usual daily dose (or extend interval); hemodialysis: give 100% of the dose after each dialysis session.

Liver Impairment

No routine dose adjustment is defined for hepatic impairment; use with caution and monitor liver function, discontinuing if clinical/laboratory hepatotoxicity develops.

Storage & Patient Advice

Missed Dose

If on a multi-dose regimen, take the missed dose as soon as remembered unless it is close to the next dose; do not double doses. (For single-dose therapy, take the dose when remembered and do not repeat unless instructed.)

Stopping the Medicine

Take exactly as prescribed; for this product (1-capsule pack) the course is typically a single 150 mg dose-do not repeat/extend without clinician advice; for multi-dose regimens, complete the prescribed course.

Overdose

Overdose may cause hallucinations/paranoid behavior and GI symptoms; manage with supportive care (consider gastric lavage if early) and note hemodialysis enhances elimination (≈50% reduction over ~3 hours).

Patient Counseling

Take by mouth with or without food; follow the prescribed regimen (single 150 mg dose for uncomplicated VVC unless otherwise directed). Expect symptom improvement over 24-72 hours for VVC; seek care if symptoms persist/return. Report rash, jaundice/dark urine, severe abdominal pain, or unusual fatigue (hepatotoxicity/serious skin reactions). Avoid/consult before use in pregnancy; discuss breastfeeding. Use caution with driving if dizzy. Tell your clinician/pharmacist about all medicines due to major interactions (especially warfarin, tacrolimus/cyclosporine, phenytoin, sulfonylureas, QT-prolonging drugs). Store below 30°C.

Pharmacology

Mechanism of Action

Inhibits fungal lanosterol 14-α-demethylase (CYP51), blocking conversion of lanosterol to ergosterol and impairing fungal cell membrane synthesis and function.

Onset of Action

Pharmacokinetic onset: peak plasma concentrations occur ~1-2 hours after an oral dose; clinical improvement depends on infection site and typically begins within ~24 hours for uncomplicated vulvovaginal candidiasis.

Duration of Effect

Terminal elimination half-life is ~30 hours; after a single 150 mg dose, clinically meaningful antifungal exposure typically persists for several days (often cited as ~72 hours for vulvovaginal candidiasis symptom response).

Half-Life

Approximately 30 hours (range: 20-50 hours). [1, 9]

Bioavailability

>90% oral bioavailability.

Metabolism

Minimal hepatic metabolism (approximately ~10%); most drug is excreted unchanged; clinically acts as a CYP2C9/2C19 inhibitor and a moderate CYP3A4 inhibitor.

Excretion

Primarily renal; ~80% excreted unchanged in urine.

Protein Binding

11-12%

Product Information

Composition per Dose

Each capsule: 150mg fluconazole

Generic Availability

Yes

OTC Alternatives

No OTC oral fluconazole alternative (this product is prescription per SFDA); OTC options are topical azoles such as clotrimazole or miconazole for localized superficial/vaginal candidiasis where appropriate.

Application

Oral

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