Schedule H

Oral

• Tablets: 125 mg, 250 mg, 500 mg (microsize)

• Ultramicrosize tablets: 125 mg, 250 mg

• Oral suspension: 125 mg/5 mL (limited availability)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Tinea Corporis / Tinea Cruris

Parameter Recommendation

Starting dose 250 mg once daily (microsize) with fatty meal

Titration Increase to 500 mg daily if poor response after 2 weeks

Usual maintenance dose 500 mg once daily or 250 mg twice daily

Maximum dose 1 g/day

Duration 3–4 weeks (continue 2 weeks beyond clinical cure)

Notes Fatty meal mandatory for adequate absorption

1. Tinea Capitis

Parameter Recommendation

Starting dose 500 mg once daily (microsize)

Titration Not applicable

Usual maintenance dose 500 mg daily

Maximum dose 1 g/day

Duration 6–8 weeks (minimum 4 weeks)

Notes Kerion variant may require concurrent short-course oral corticosteroids; continue until mycological cure

1. Tinea Pedis / Tinea Manuum

Parameter Recommendation

Starting dose 500 mg once daily (microsize)

Titration Not applicable

Usual maintenance dose 500 mg daily

Maximum dose 1 g/day

Duration 4–8 weeks; recalcitrant cases may need up to 3 months

Notes Higher failure rates compared to tinea corporis

1. Onychomycosis (Dermatophyte Nail Infection)

Parameter Recommendation

Starting dose 500 mg twice daily (microsize)

Titration Not applicable

Usual maintenance dose 1 g/day in divided doses

Maximum dose 1 g/day

Duration Fingernails: 4–6 months; Toenails: 6–12 months

Notes Inferior efficacy compared to terbinafine and itraconazole; consider alternatives as first-line

Ultramicrosize Formulation Conversion:

• Ultramicrosize dose is approximately 60–70% of microsize dose

• 330–375 mg ultramicrosize ≈ 500 mg microsize

• 660–750 mg ultramicrosize ≈ 1000 mg microsize

Secondary Indications – Adults (Off-label, if any)

Not applicable — No consistent off-label uses documented in Indian specialist practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Tinea Capitis (Most Common Paediatric Indication)

Weight Category Starting Dose Usual Maintenance Dose Maximum Dose

10–20 kg 125 mg once daily 10–15 mg/kg/day (divided BID) 500 mg/day

20–40 kg 250 mg once daily 10–15 mg/kg/day (divided BID) 750 mg/day

40 kg 500 mg once daily 500 mg/day 1 g/day

Tinea Corporis / Tinea Cruris in Children

Parameter Recommendation

Starting dose 10 mg/kg/day (microsize)

Titration Increase to 15 mg/kg/day if inadequate response

Usual maintenance dose 10–15 mg/kg/day, given in 1–2 divided doses

Maximum dose 500 mg/day (children <40 kg)

Duration 2–4 weeks

Administration Notes:

• Always give with fatty food or whole milk to enhance absorption

• Minimum age: 2 years (use below 2 years only under specialist supervision)

• Duration for scalp infections: minimum 6 weeks

• Monitor for photosensitivity; advise sun protection

Secondary Indications – Paediatric Doses (Off-label, if any)

Not applicable — No established off-label paediatric uses in Indian practice.

• Mild to moderate impairment (eGFR 30–89 mL/min): No dose adjustment required

• Severe impairment (eGFR <30 mL/min): Use with caution; no specific dosing data available. Monitor hepatic function as drug is primarily hepatically metabolised

• Haemodialysis: Not significantly dialysed; no supplemental dose required

• Known hypersensitivity to griseofulvin or any excipients

• Severe hepatic impairment or active liver disease

• Porphyria (acute intermittent, variegate, or hereditary coproporphyria)

• Systemic lupus erythematosus or lupus-like syndromes

• Pregnancy (teratogenic — absolutely contraindicated)

• Concomitant use with drugs causing disulfiram-like reactions if alcohol use cannot be avoided

• Pre-existing liver dysfunction — monitor LFTs closely

• Prolonged therapy (>6 months) — increased risk of hepatotoxicity and bone marrow suppression

• History of photosensitivity or significant sun exposure

• Women on hormonal contraceptives — reduced efficacy; advise barrier contraception

• Penicillin allergy — theoretical cross-reactivity (derived from Penicillium species), though clinical significance uncertain

• Male patients planning conception — advise contraception during treatment and for 6 months after (potential mutagenicity)

• Children below 2 years — safety not established

Parameter Details

Risk category Contraindicated (teratogenic in animal studies; embryotoxicity reported)

Trimester-specific Avoid in all trimesters

Pre-treatment requirement Pregnancy test recommended in women of childbearing potential before initiation

Contraceptive advice Effective contraception during treatment and for 1 month after discontinuation

Preferred alternatives Topical antifungals for localised infections; specialist consultation for extensive disease

Parameter Details

Compatibility Probably compatible — low excretion into breast milk expected

Milk levels Low (limited data)

Preferred alternatives Topical antifungals (clotrimazole, miconazole) for localised infections

Infant monitoring Observe for gastrointestinal upset, rash, or feeding difficulties

Recommendation Avoid prolonged or high-dose courses; use topical alternatives where feasible

• Starting dose: 250 mg once daily (lower end of dosing range)

• Titration: Increase slowly based on clinical response and tolerability

• Special considerations:

• Increased susceptibility to photosensitivity reactions

• Higher risk of drug interactions (polypharmacy common)

• Monitor hepatic and renal function before and during therapy

• Increased risk of neurological adverse effects (confusion, dizziness)

• Limit treatment duration; reassess need at 4–6 weeks

Interacting Drug Effect Recommendation

Warfarin Decreased anticoagulant effect (CYP enzyme induction) Avoid combination or increase warfarin dose with close INR monitoring

Oral contraceptives Reduced contraceptive efficacy (enzyme induction) Use additional barrier contraception during and for 1 month after therapy

Alcohol Disulfiram-like reaction (flushing, tachycardia, nausea) Advise complete alcohol avoidance

Barbiturates (phenobarbital) Reduced griseofulvin plasma levels Avoid combination; consider alternative antifungal

Interacting Drug Effect Recommendation

Ciclosporin Possible decreased ciclosporin levels Monitor ciclosporin concentrations in transplant patients

Phenytoin Mutual enzyme induction; altered levels of both drugs Monitor phenytoin levels and clinical response

Salicylates Possible reduced griseofulvin absorption Space administration by 2 hours if possible

Itraconazole Potential antagonism in vitro Avoid concurrent use for dermatophyte infections

• Headache (most frequent — occurs in up to 15%)

• Nausea and epigastric discomfort

• Vomiting

• Diarrhoea

• Skin rash and urticaria

• Photosensitivity

• Fatigue and malaise

• Dizziness

Adverse Effect Action Required

Hepatotoxicity (elevated ALT/AST, jaundice) Discontinue immediately; supportive care

Granulocytopenia / leukopenia Monitor CBC; discontinue if significant

Stevens–Johnson syndrome / Toxic epidermal necrolysis Immediate discontinuation; hospitalisation

Severe photosensitivity reaction Discontinue; advise strict sun avoidance

Lupus-like syndrome Discontinue; specialist evaluation

Peripheral neuropathy (rare, prolonged use) Consider discontinuation; neurological assessment

After 2–4 weeks Clinical response assessment; check for rash or adverse effects

Every 6–8 weeks (if therapy >8 weeks) LFTs, CBC

Long-term therapy LFTs and CBC every 2 months; clinical assessment for neurological symptoms

Clinical Sun exposure counselling; contraceptive compliance in women

• Grisovin FP (GlaxoSmithKline)

• Griseofulvin (generic)

• Fulvicin

• Griseo-F

• Gfulvin

• Gris-OD

Note: Verify whether formulation is microsize or ultramicrosize before prescribing — doses differ.

• NLEM Status: Not included in NLEM 2022

• Government supply: Available at lower prices through state dermatology/leprosy programmes in some states

1. Fatty meal is essential — bioavailability increases 2–3 fold when taken with fatty food; counsel every patient

1. Verify formulation type — microsize and ultramicrosize are NOT interchangeable at same dose; ultramicrosize requires 30–40% lower dosing

1. Not first-line for nail infections — terbinafine and itraconazole have superior cure rates for onychomycosis

1. Contraceptive counselling mandatory — warn all women on hormonal contraceptives about reduced efficacy; document discussion

1. Prolonged therapy requires monitoring — any treatment beyond 8 weeks needs periodic LFT and CBC surveillance

1. Preferred for paediatric tinea capitis — remains useful in children due to long safety experience and availability

griseofulvin; antifungal; dermatophytosis; tinea capitis; tinea corporis; oral antifungal; paediatric-use; hepatic-monitoring; photosensitivity; pregnancy-contraindicated; dermatology

RxIndia v1.1 — 14 May 2025

• CDSCO approved product information

• Indian Pharmacopoeia 2018

• National Formulary of India 2021

• API Textbook of Medicine

• IAP Guidelines: Management of Tinea in Children

• ICMR Consensus Statement on Dermatophytosis 2019

• AIIMS Department of Dermatology Treatment Protocols

• IADVL Guidelines for Management of Dermatophytosis