CANDIVAST 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, and prophylaxis to reduce candidiasis in high-risk immunocompromised patients (e.g., bone marrow transplant with cytotoxic therapy/radiation).

Off-Label Uses

Common off-label/selected-use scenarios include suppressive therapy for recurrent vulvovaginal candidiasis, certain endemic mycoses (e.g., coccidioidomycosis) when appropriate, and antifungal prophylaxis in select neonatal/high-risk settings per institutional protocols; superficial tinea/onychomycosis uses are often off-label and generally not first-line versus terbinafine/topicals.

Dosage & Administration

Dosing by Condition

Vulvovaginal candidiasis (uncomplicated): 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 100-200 mg PO daily for at least 14-21 days. Cryptococcal meningitis (consolidation/maintenance after induction): commonly 400 mg PO daily for ~8 weeks (consolidation) then 200 mg PO daily (maintenance), duration individualized; fluconazole monotherapy is not preferred for induction. Invasive candidiasis/candidemia: typically 800 mg (12 mg/kg) loading then 400 mg (6 mg/kg) daily (step-down when appropriate), duration based on source control and clearance.

Initial Dose

150mg as a single dose (vaginal candidiasis).

Maintenance Dose

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

Maximum Dose

400mg per day.

Children's Dosage

Oropharyngeal candidiasis: 3mg/kg once daily (max 100mg/day). Esophageal candidiasis: 3-6mg/kg once daily (max 200mg/day). Systemic candidiasis/cryptococcal meningitis: 6-12mg/kg once daily (max 400mg/day). Not recommended in neonates under 2 weeks except in life-threatening situations

Dose Adjustment Notes

Renal: 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. Hepatic: no specific dose adjustment is defined, but use with caution and monitor liver function if clinically indicated.

How to Take

Oral use: swallow the 150 mg capsule whole with water; may be taken with or without food. For uncomplicated vulvovaginal candidiasis, the usual regimen is a single 150 mg oral dose (one capsule).

Side Effects

Common Side Effects

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

Side Effect Frequency

Fluconazole 150 mg (oral, single-dose): Common (≥1% to <10%): headache, nausea, abdominal pain, diarrhea, rash, vomiting, increased ALT/AST. Uncommon (≥0.1% to <1%): dizziness, dyspepsia, taste disturbance, constipation, fatigue. Rare/very rare (<0.1%): serious hypersensitivity (anaphylaxis/angioedema), severe cutaneous adverse reactions (SJS/TEN), severe hepatotoxicity/hepatic failure, QT prolongation/torsades de pointes, seizures, blood dyscrasias (leukopenia/thrombocytopenia).

Safety & Warnings

Contraindications

Contraindicated in patients with hypersensitivity to fluconazole/other azoles; and with concomitant use of QT-prolonging CYP3A4 substrates where increased exposure can cause serious arrhythmias (cisapride, astemizole, pimozide, quinidine, erythromycin); terfenadine is contraindicated when fluconazole is used at multiple doses ≥400 mg/day.

Warnings & Precautions

Use caution/monitor in hepatic disease (stop if liver injury develops), in patients with QT-prolongation risk or on interacting QT-prolonging drugs, and discontinue at first sign of severe rash; adjust/monitor in renal impairment and review for major CYP-mediated interactions.

Age Restriction

Adults and adolescents: 150 mg single oral dose is standard for uncomplicated vulvovaginal candidiasis; pediatric use is indication- and weight-based and the 150 mg single-dose capsule is generally not appropriate for young children-use in children/adolescents should be under physician supervision (especially <16 years for VVC).

Drug Interactions

Drug Interactions

Fluconazole inhibits CYP2C9/2C19 and (moderately) CYP3A4: clinically important interactions include warfarin (↑INR), phenytoin (↑levels), cyclosporine/tacrolimus (↑levels), sulfonylureas (↑hypoglycemia), theophylline (↑levels), certain benzodiazepines (↑sedation), some statins (↑myopathy risk), rifampicin/rifampin (↓fluconazole exposure), and hydrochlorothiazide (↑fluconazole levels); QT-prolonging CYP3A4 substrates such as cisapride/pimozide/quinidine/erythromycin are contraindicated.

Interaction Severity

MAJOR/CONTRAINDICATED: coadministration with QT-prolonging CYP3A4 substrates such as cisapride, pimozide, quinidine, and erythromycin (risk of torsades/QT prolongation); terfenadine is contraindicated particularly at higher fluconazole doses (e.g., ≥400 mg/day). MODERATE/SIGNIFICANT: warfarin (↑INR/bleeding), phenytoin (↑levels), cyclosporine/tacrolimus (↑levels/toxicity), sulfonylureas (hypoglycemia), certain statins (myopathy/rhabdo risk), benzodiazepines (↑sedation), rifampin/rifabutin (↓fluconazole or altered exposure). MINOR: hydrochlorothiazide (slight ↑fluconazole exposure).

Food Interaction

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

Special Populations

Pregnancy

Category D.

Breastfeeding

Caution

Children

Oropharyngeal candidiasis: 3mg/kg once daily (max 100mg/day). Esophageal candidiasis: 3-6mg/kg once daily (max 200mg/day). Systemic candidiasis/cryptococcal meningitis: 6-12mg/kg once daily (max 400mg/day). Not recommended in neonates under 2 weeks except in life-threatening situations

Elderly

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

Kidney Impairment

CrCl >50 mL/min: no adjustment; CrCl ≤50 mL/min (not on dialysis): give a normal loading dose if multiple-dose therapy is used, then 50% of the usual maintenance dose; hemodialysis: give the full dose after each dialysis session.

Liver Impairment

No specific dose adjustment is defined for hepatic impairment; use with caution and monitor liver function, discontinuing if clinically significant hepatotoxicity occurs.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next dose; do not double the dose

Stopping the Medicine

Do not stop early if a multi-dose regimen is prescribed; for this product’s common use (150 mg single dose), no further doses are needed after taking the capsule, but patients should seek review if symptoms persist/return.

Overdose

Overdose may cause hallucinations/paranoid behavior and GI symptoms; management is supportive (consider gastric lavage if recent) and hemodialysis can remove ~50% of fluconazole over ~3 hours.

Patient Counseling

Take exactly as prescribed; for uncomplicated vaginal yeast infection this is usually one 150 mg capsule taken once. May take with or without food; swallow whole with water. Seek care urgently for severe rash/blistering, facial swelling, or breathing difficulty. Report signs of liver injury (jaundice, dark urine, persistent nausea/abdominal pain) and inform clinicians of all medicines due to important interactions (e.g., warfarin, tacrolimus/cyclosporine, phenytoin, QT-prolonging drugs). Use caution with driving if dizzy. Store below 25°C and keep out of reach of children.

Pharmacology

Mechanism of Action

Inhibits fungal lanosterol 14-α-demethylase (CYP51), blocking ergosterol synthesis and impairing fungal cell membrane formation and function (primarily fungistatic against Candida spp.).

Onset of Action

Tmax ~1-2 hours after oral dosing; symptom improvement timing varies by infection (for uncomplicated vulvovaginal candidiasis, improvement often begins within ~24 hours, with full resolution over several days).

Duration of Effect

Elimination half-life is ~30 hours, supporting once-daily dosing; clinical effect duration depends on indication (e.g., single 150 mg dose often provides therapeutic exposure for several days in uncomplicated vulvovaginal candidiasis).

Half-Life

~30 hours (range 20-50 hours)

Bioavailability

Oral bioavailability >90%.

Metabolism

Minimal hepatic metabolism; most of the dose is excreted unchanged in urine. Fluconazole inhibits CYP2C9 and CYP2C19 and is a moderate inhibitor of CYP3A4.

Excretion

Primarily renal, with over 80% of the administered dose excreted as unchanged drug in the urine.

Protein Binding

11-12%.

Product Information

Available Dosage Forms

Tablet, Powder for Suspension, Injection for intravenous infusion, Oral suspension

Composition per Dose

Each capsule: 150mg fluconazole

Generic Availability

Yes

OTC Alternatives

No OTC oral fluconazole alternative (this product is prescription-only per SFDA); OTC options are topical azole antifungals such as clotrimazole or miconazole for appropriate superficial/vaginal yeast infections where self-care is suitable.

Application

Oral

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.