schedule H

Oral, Intravenous

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)

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

1. 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

1. 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

1. 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

1. 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

1. 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 DOSING (Specialist Only)

Primary Indications

1. Oropharyngeal/Oesophageal Candidiasis

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

1. Systemic Candidiasis (Candidemia)

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

1. 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)

≤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

• 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)

• 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

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

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

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)

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.

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

• Nausea

• Abdominal pain

• Diarrhoea

• Headache

• Skin rash (non-serious)

• Elevated hepatic transaminases (usually transient)

• Dyspepsia

• Dizziness

• Taste disturbance

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

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)

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.

NLEM 2022 Status: Included — NPPA price control applicable for essential strengths (50 mg, 150 mg tablets; injection).

1. CSF penetration: Fluconazole is the only azole with reliable CSF penetration (~70–80% of plasma levels) — drug of choice for cryptococcal meningitis consolidation/maintenance.

1. 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.

1. 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.

1. Warfarin interaction: One of the most clinically significant interactions; INR may rise within days — proactive monitoring and warfarin dose reduction usually needed.

1. Hepatotoxicity awareness: Less hepatotoxic than ketoconazole, but LFT monitoring essential in prolonged/high-dose regimens; discontinue if transaminases rise significantly.

1. Renal dosing: Remember to halve maintenance dose when eGFR <50 mL/min — commonly overlooked in practice.

1. Not effective against: Candida krusei (intrinsically resistant), Candida glabrata (frequently resistant), Aspergillus species, Mucormycosis agents.

fluconazole; triazole antifungal; candidiasis; cryptococcal meningitis; vulvovaginal candidiasis; oropharyngeal thrush; systemic fungal infection; hepatotoxicity; QT prolongation; renal-adjustment; pregnancy-caution; NLEM India

RxIndia v1.1 — 30 May 2025

• 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