Not under Schedule H/X (Over-the-counter topical)

Topical

• Amorolfine 0.25% cream (15 g tube)

• Amorolfine 5% nail lacquer (2.5 mL, 5 mL bottles)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Onychomycosis (Dermatophytes, Yeasts, Moulds)

Parameter Details

Formulation 5% Nail lacquer

Starting dose Apply once weekly to affected nail(s)

Titration May increase to twice weekly if response inadequate

Usual maintenance dose Once or twice weekly application

Maximum dose Not applicable (topical)

Duration Fingernails: 6 months; Toenails: 9–12 months

Clinical Notes:

• File affected nail surface before each application

• Clean nail with alcohol swab and allow to dry

• Apply lacquer evenly using provided applicator

• Avoid cosmetic nail lacquers during treatment

• Continue until clear nail regrowth is complete

1. Cutaneous Mycoses (Tinea corporis, Tinea cruris, Tinea pedis)

Parameter Details

Formulation 0.25% Cream

Starting dose Apply once daily to affected skin

Titration Not applicable

Usual maintenance dose Once daily application

Maximum dose Not applicable (topical)

Duration 2–4 weeks; continue for 1 week after clinical resolution

Clinical Notes:

• Apply thin layer to lesion and surrounding area

• Wash hands after application unless treating hands

• Improvement usually visible within 1 week

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

Indication Dose Duration Notes

Superficial cutaneous candidiasis 0.25% cream once daily 2–3 weeks OFF-LABEL — Limited Indian data; extrapolated from international practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not routinely approved for children under 18 years. Limited safety and efficacy data available in paediatric population.

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

Indication Age Dose Duration Notes

Onychomycosis ≥12 years 5% lacquer once weekly 6–12 months OFF-LABEL — Specialist only; use when oral antifungals contraindicated

Cutaneous mycoses ≥12 years 0.25% cream once daily 2–4 weeks OFF-LABEL — Limited paediatric data

Safety Monitoring:

• Monitor for local irritation, contact dermatitis

• Discontinue if allergic reaction occurs

⚠️ Not recommended in children <12 years except under dermatology supervision.

No adjustment required — minimal systemic absorption with topical application.

Topical formulation with negligible systemic absorption and hepatic metabolism.

• Known hypersensitivity to amorolfine or any excipient in formulation

• Application on open wounds, broken skin, or acute inflamed areas (cream formulation)

• Periungual bacterial or viral infections (lacquer formulation)

• Avoid contact with eyes, ears, or mucous membranes

• Do not use intravaginally

• Nail lacquer: Avoid use of occlusive dressings; do not apply cosmetic nail products over treatment

• Cream: Discontinue if severe local irritation or allergic contact dermatitis develops

• Immunocompromised patients (uncontrolled diabetes, HIV): Higher risk of treatment failure — consider systemic antifungal therapy if response inadequate

• Use with caution near periungual skin folds

Parameter Details

Risk statement No adequate human data; animal studies show no teratogenicity

Recommendation Prefer to avoid unless benefit outweighs risk

Preferred alternatives Clotrimazole cream (topical) for cutaneous infections

When permissible Small treatment areas only; under obstetrician guidance

Monitoring Local skin reaction; no systemic monitoring required

Parameter Details

Compatibility Compatible with breastfeeding if applied to non-breast areas

Drug levels in milk Negligible (minimal systemic absorption)

Recommendation Avoid application on chest/breast skin

Infant monitoring Local irritation if accidental contact occurs

Parameter Details

Dose adjustment Not required

Special considerations Slower nail growth — expect longer treatment duration for onychomycosis (may exceed 12 months)

Monitoring Skin fragility; higher risk of contact dermatitis

None reported — minimal systemic absorption with topical use.

Interacting Agent Effect/Mechanism Management

Other topical antifungals (same site) May dilute/inactivate effects Avoid concurrent application on same area

Nail cosmetics/removers with organic solvents May reduce lacquer efficacy Avoid during treatment; clean nails only with alcohol swab

Occlusive emollients (on treated nails) May reduce lacquer adhesion Avoid application over nail lacquer

• Mild burning or stinging at application site

• Localised dryness, erythema, or pruritus

• Nail discolouration (with lacquer)

• Brittle or fragile nails (with prolonged lacquer use)

• Skin irritation or peeling (cream)

Adverse Effect Management

Allergic contact dermatitis Discontinue immediately; consider topical corticosteroid

Onycholysis (nail detachment) Rare; discontinue and reassess diagnosis

Secondary bacterial infection of treated area Rare; may require antibiotic therapy

Periungual inflammation/paronychia Discontinue; assess for bacterial co-infection

Phase Parameters

Baseline Confirm fungal diagnosis (KOH mount, fungal culture); document nail involvement extent

During therapy Monthly: assess for local irritation, dermatitis; monitor nail regrowth progress

Long-term Confirm mycological cure at end of treatment; assess for recurrence at 3–6 months post-treatment

• Loceryl® (Galderma)

• Amorolf™ (Glenmark)

• Amoroz™ (Zydus)

• Amfolac® (Alkem)

• Nailrox® (Cipla)

• Morolfin® (Micro Labs)

• Fungizone NL® (Sun Pharma)

0.25% Cream 15 g ₹180–₹350

Not listed under NLEM — not under NPPA price control.

1. Patient selection: Topical amorolfine is most effective for mild–moderate distal-lateral subungual onychomycosis involving <50% of nail plate; consider oral antifungals for extensive, proximal, or matrix involvement.

1. Adherence counselling: Treatment success is highly dependent on compliance — missed weekly applications significantly reduce cure rates.

1. Nail preparation: Proper filing and cleaning before each lacquer application is essential for adequate drug penetration.

1. Duration expectations: Counsel patients that complete nail regrowth takes 6–12 months — visible improvement is gradual and patience is required.

1. Combination therapy: In moderate cases, combining lacquer with oral terbinafine may improve cure rates (specialist decision).

1. Treatment failure: If no improvement after 3 months, reassess diagnosis and consider systemic therapy.

amorolfine; antifungal; topical; onychomycosis; tinea; dermatophyte; nail lacquer; morpholine; dermatology; pregnancy-caution; paediatric-off-label

RxIndia v1.0 — 01 May 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia / National Formulary of India 2021

• AIIMS Formulary

• API Textbook of Medicine, 11th edition

• Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) guidelines

• Manufacturer prescribing information (India)