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Fluconazole Uses, Dosage, Side Effects & Price | DrugsAtlas

Authoritative Clinical Reference

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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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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