Fluconazole Uses, Dosage, Side Effects & Price | DrugsAtlas
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Therapeutic Class
Antifungal
Subclass
Triazole antifungal
Speciality
Infectious Diseases,
Schedule (India)
schedule H
Routes
Oral, Intravenous
Formulations
| Form | Available Strengths |
|---|---|
| Tablets | 50 mg, 100 mg, 150 mg, 200 mg |
| Oral Suspension | 50 mg/5 mL |
| IV Infusion | 2 mg/mL (100 mL bottle = 200 mg; 200 mL bottle = 400 mg) |
Adult indications
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Vulvovaginal Candidiasis (Uncomplicated)
| Parameter | Recommendation |
|---|---|
| Starting dose | 150 mg orally once (single dose) |
| Titration | Not applicable |
| Usual maintenance dose | Not applicable (single-dose therapy) |
| Maximum dose | 150 mg single dose |
Recurrent Vulvovaginal Candidiasis (≥4 episodes/year):
| Parameter | Recommendation |
|---|---|
| Starting dose | 150 mg orally once every 72 hours × 3 doses |
| Maintenance (prophylaxis) | 150 mg once weekly × 6 months |
| Maximum dose | 150 mg/week |
| Note | Specialist supervision advised |
2. Oropharyngeal Candidiasis
| Parameter | Recommendation |
|---|---|
| Starting dose | 200 mg orally on Day 1 |
| Titration | Not applicable |
| Usual maintenance dose | 100 mg once daily |
| Maximum dose | 200 mg/day (immunocompromised patients) |
| Duration | 7–14 days |
3. Oesophageal Candidiasis
| Parameter | Recommendation |
|---|---|
| Starting dose | 200 mg orally/IV on Day 1 |
| Titration | Not applicable |
| Usual maintenance dose | 100–200 mg once daily |
| Maximum dose | 400 mg/day in refractory cases |
| Duration | Minimum 14–21 days; continue ≥7 days after symptom resolution |
4. Systemic Candidiasis (Candidemia, Disseminated Candidiasis)
| Parameter | Recommendation |
|---|---|
| Starting dose (loading) | 800 mg IV/oral on Day 1 |
| Titration | Not applicable |
| Usual maintenance dose | 400 mg once daily |
| Maximum dose | 800 mg/day |
| Duration | ≥14 days after last positive blood culture and clinical resolution |
5. Cryptococcal Meningitis (HIV-related and others)
| Phase | Dose | Duration |
|---|---|---|
|
Induction (with Amphotericin B)
|
800 mg/day orally/IV | ≥2 weeks (or until CSF sterile) |
|
Consolidation
|
400 mg once daily | 8 weeks |
|
Maintenance/Secondary prophylaxis
|
200 mg once daily | Long-term (until immune reconstitution in HIV) |
| Parameter | Recommendation |
|---|---|
| Starting dose | 800 mg/day (induction phase) |
| Maximum dose | 800 mg/day |
6. Tinea Infections
| Condition | Dose | Duration |
|---|---|---|
| Onychomycosis (fingernail) | 150 mg once weekly | 3–6 months |
| Onychomycosis (toenail) | 150 mg once weekly | 6–12 months |
| Tinea corporis/cruris/pedis | 150 mg once weekly OR 50 mg daily | 2–6 weeks |
Secondary Indications — Adults (Off-label)
| Indication | Dose | Duration | Evidence/Notes |
|---|---|---|---|
|
Prophylaxis in neutropenic patients
|
400 mg orally/IV once daily | Throughout neutropenia period | OFF-LABEL; Specialist only; High-risk haematology units; supported by international RCTs |
|
Tinea capitis (refractory cases)
|
6 mg/kg/day orally (max 400 mg/day) | 2–6 weeks | OFF-LABEL; Dermatology specialist only; when griseofulvin/terbinafine fail |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
1. Oropharyngeal/Oesophageal Candidiasis
| Age Group | Loading Dose (Day 1) | Maintenance Dose | Duration |
|---|---|---|---|
| 6 months–12 years | 6 mg/kg orally | 3 mg/kg/day (mild–moderate) | 7–14 days |
| 6 mg/kg/day (severe/immunocompromised) | |||
| >12 years | Adult dosing | Adult dosing | As per adult |
2. Systemic Candidiasis (Candidemia)
| Age Group | Dose | Frequency | Duration |
|---|---|---|---|
| Neonates (0–14 days) | 12 mg/kg | Every 72 hours | ≥14 days after last positive culture |
| Neonates (15–28 days) | 12 mg/kg | Every 48 hours | |
| Infants/Children (>1 month) | 6–12 mg/kg/day | Once daily |
3. Cryptococcal Meningitis
| Phase | Dose | Maximum | Duration |
|---|---|---|---|
| Induction | 12 mg/kg/day | 800 mg/day | As per ID specialist |
| Consolidation/Maintenance | 6–12 mg/kg/day | 400 mg/day | Prolonged; ID specialist supervision |
Secondary Indications — Paediatrics (Off-label)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
|
Tinea capitis
|
6 mg/kg/day orally | 2–6 weeks | OFF-LABEL; Specialist dermatology use only |
Paediatric Safety Notes
| Parameter | Recommendation |
|---|---|
| Minimum age | Not recommended <6 months except under specialist supervision |
| Baseline monitoring | LFTs, renal function |
| During therapy | LFTs at 1–2 weeks; monitor for rash, GI symptoms |
| Renal adjustment | Apply as per adult renal dosing (mg/kg basis) |
Renal Adjustments''
| eGFR (mL/min) | Dose Modification |
|---|---|
| ≥50 | No adjustment required |
| 11–49 | Give full loading dose; then 50% of maintenance dose |
| ≤10 | Give full loading dose; then 50% of maintenance dose |
|
Haemodialysis
|
Full dose after each dialysis session |
|
Peritoneal dialysis
|
Adjust based on residual renal function; specialist input advised |
Hepatic adjustment
Contraindications
- Known hypersensitivity to fluconazole or other azole antifungals
- Concomitant use with terfenadine (when fluconazole dose >400 mg/day)
- Concomitant use with cisapride
- Concomitant use with pimozide
- Concomitant use with quinidine (risk of QT prolongation/torsades de pointes)
Cautions'
- Pre-existing hepatic disease — monitor LFT trends closely
- Known QT prolongation or concurrent use of QT-prolonging drugs
- Pregnancy — avoid unless essential (see Pregnancy section)
- Elderly patients — assess renal function before dosing
- Patients on multiple CYP3A4 substrates
- Proarrhythmic conditions (electrolyte imbalance, bradycardia, structural heart disease)
- History of drug-induced skin reactions
Pregnancy
| Parameter | Recommendation |
|---|---|
|
Overall risk
|
Generally contraindicated for prolonged/high-dose use |
|
Single low-dose (150 mg)
|
Limited data suggest relative safety; avoid in 1st trimester if possible |
|
High-dose/prolonged use
|
Associated with skeletal and craniofacial teratogenicity |
|
Indian practice
|
Avoid in pregnancy, especially 1st trimester |
|
Preferred alternatives
|
Topical clotrimazole or nystatin for vulvovaginal candidiasis |
|
When systemic use essential
|
Specialist (Obstetrician + ID) input mandatory |
|
Monitoring
|
Detailed obstetric evaluation; fetal anomaly scan if exposure occurred |
Lactation
| Parameter | Recommendation |
|---|---|
|
Compatibility
|
Compatible with breastfeeding for short courses at standard doses |
|
Drug levels in milk
|
Low to moderate (similar to plasma concentrations) |
|
Single 150 mg dose
|
No need to interrupt breastfeeding |
|
Preferred alternatives
|
Topical antifungals if treatment duration prolonged |
|
Infant monitoring
|
GI symptoms (diarrhoea, vomiting), feeding pattern changes, excessive drowsiness |
Elderly
| Parameter | Recommendation |
|---|---|
|
Starting dose
|
Start at lower end of adult dosing range |
|
Titration
|
Slower titration if dose escalation required |
|
Renal function
|
Mandatory assessment before initiating; age-related decline common |
|
Additional risks
|
Increased risk of QT prolongation, hepatotoxicity, drug interactions |
|
Drug interactions
|
Review concurrent medications carefully (polypharmacy common) |
Major drug interactions
| Interacting Drug | Effect | Recommendation |
|---|---|---|
|
Cisapride
|
QT prolongation → Torsades de pointes |
Contraindicated
|
|
Pimozide
|
QT prolongation → Torsades de pointes |
Contraindicated
|
|
Quinidine
|
QT prolongation → Torsades de pointes |
Contraindicated
|
|
Terfenadine
|
QT prolongation (at fluconazole >400 mg/day) |
Contraindicated
|
|
Warfarin
|
Increased INR; bleeding risk | Enhanced INR monitoring; reduce warfarin dose as needed |
|
Phenytoin
|
Increased phenytoin levels → toxicity | Monitor phenytoin levels; reduce dose if required |
|
Rifampicin
|
Reduced fluconazole efficacy (CYP induction) | May need fluconazole dose increase; monitor response |
|
Erythromycin
|
Additive QT prolongation | Avoid combination if possible |
|
Voriconazole
|
Overlapping toxicity; no added benefit | Avoid combination unless no alternative |
Mechanism: Fluconazole is a potent inhibitor of CYP2C9, CYP2C19, and moderate inhibitor of CYP3A4.
Moderate drug interactions
| Interacting Drug | Effect | Recommendation |
|---|---|---|
|
Sulfonylureas (glibenclamide, glimepiride)
|
Hypoglycaemia risk | Monitor blood glucose closely |
|
Midazolam/Triazolam
|
Prolonged sedation | Reduce benzodiazepine dose; monitor for oversedation |
|
Cyclosporine
|
Increased cyclosporine levels | Monitor drug levels; adjust dose accordingly |
|
Tacrolimus
|
Increased tacrolimus levels | Monitor drug levels; nephrotoxicity risk |
|
Simvastatin/Atorvastatin
|
Increased statin exposure → myopathy risk | Use lowest effective statin dose; monitor for muscle symptoms |
|
Zidovudine
|
Increased zidovudine levels | Monitor for zidovudine toxicity |
|
Nevirapine
|
Altered metabolism | Monitor for efficacy and toxicity |
|
Isoniazid
|
Additive hepatotoxicity risk | Monitor LFTs more frequently |
|
Carbamazepine
|
Increased carbamazepine levels | Monitor for toxicity; check drug levels |
|
Theophylline
|
Increased theophylline levels | Monitor theophylline levels |
|
Oral contraceptives
|
Possible altered efficacy | Clinical significance uncertain; advise barrier methods if concerned |
Common Adverse effects
- Nausea
- Abdominal pain
- Diarrhoea
- Headache
- Skin rash (non-serious)
- Elevated hepatic transaminases (usually transient)
- Dyspepsia
- Dizziness
- Taste disturbance
Serious Adverse effects
| Adverse Effect | Clinical Notes |
|---|---|
|
Hepatotoxicity
|
Can be fatal; discontinue immediately if significant transaminase elevation (>3× ULN with symptoms or >5× ULN asymptomatic) |
|
Stevens-Johnson Syndrome/TEN
|
Discontinue immediately; hospitalisation required |
|
QT prolongation/Torsades de pointes
|
Risk increased with other QT-prolonging drugs, electrolyte imbalance |
|
Severe anaphylaxis
|
Rare; immediate discontinuation and emergency management |
|
Agranulocytosis
|
Rare; mostly with high-dose/prolonged therapy |
|
Alopecia
|
Reversible; reported with prolonged high-dose therapy |
|
Adrenal insufficiency
|
Rare; with very high doses |
Monitoring requirements'
| Timing | Parameters |
|---|---|
|
Baseline
|
LFTs (AST, ALT, bilirubin), Creatinine/eGFR, ECG (if on QT-prolonging drugs or cardiac risk) |
|
After initiation (1–2 weeks)
|
Repeat LFTs (especially for IV or high-dose therapy); monitor for rash, allergic symptoms |
|
Long-term (>4 weeks)
|
Monthly LFTs; Complete blood counts if therapy >6 weeks; periodic renal function |
|
Special situations
|
Drug levels of interacting medications (phenytoin, cyclosporine, tacrolimus) |
Brands in India
| Brand Name | Manufacturer |
|---|---|
| Zocon | FDC Ltd |
| Forcan | Cipla |
| Flucos | Mankind |
| Fluka | Zydus |
| Syscan | Sun Pharma |
| Fungitek | Various |
| Diflucan | Pfizer (originator) |
Note: Numerous other generic brands available across India.
Price range (INR)
| Formulation | Approximate Price |
|---|---|
| 150 mg tablet (single) | ₹8–30 |
| 100 mg tablet (strip of 10) | ₹40–120 |
| 50 mg tablet (strip of 10) | ₹30–80 |
| 200 mg tablet (strip of 4) | ₹50–150 |
| Oral suspension 50 mg/5 mL (35 mL) | ₹50–100 |
| IV infusion 200 mg/100 mL | ₹70–150 |
| IV infusion 400 mg/200 mL | ₹120–250 |
NLEM 2022 Status: Included — NPPA price control applicable for essential strengths (50 mg, 150 mg tablets; injection).
Clinical pearls
- CSF penetration: Fluconazole is the only azole with reliable CSF penetration (~70–80% of plasma levels) — drug of choice for cryptococcal meningitis consolidation/maintenance.
- Single-dose convenience: 150 mg single dose remains first-line for uncomplicated vulvovaginal candidiasis; educate patients that symptoms may take 2–3 days to resolve.
- Loading dose principle: Due to long half-life (~30 hours), always give loading dose (usually double the maintenance) on Day 1 for serious infections to achieve steady state faster.
- Warfarin interaction: One of the most clinically significant interactions; INR may rise within days — proactive monitoring and warfarin dose reduction usually needed.
- Hepatotoxicity awareness: Less hepatotoxic than ketoconazole, but LFT monitoring essential in prolonged/high-dose regimens; discontinue if transaminases rise significantly.
- Renal dosing: Remember to halve maintenance dose when eGFR <50 mL/min — commonly overlooked in practice.
- Not effective against:Candida krusei (intrinsically resistant), Candida glabrata (frequently resistant), Aspergillus species, Mucormycosis agents.
Version'
RxIndia v1.1 — 30 May 2025
Reference
- CDSCO approved prescribing information
- Indian Pharmacopoeia (IP)
- National List of Essential Medicines (NLEM) 2022
- API Textbook of Medicine
- AIIMS Antifungal Guidelines
- ICMR Guidelines for management of fungal infections
- Harrison's Principles of Internal Medicine (21st Edition)
- WHO Model List of Essential Medicines (paediatric dosing support)
- Goodman & Gilman's The Pharmacological Basis of Therapeutics
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Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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