Schedule H

Topical (cutaneous, mucocutaneous)

• Topical solution: 0.5%

• Topical cream: 0.15%

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

External Anogenital Warts (Condyloma Acuminata — HPV-related)

Suitable only for external genital and perianal warts; NOT for urethral, intra-anal, vaginal, or cervical lesions

0.5% Solution Formulation:

Parameter Recommendation

Starting dose Apply thin layer to visible external wart lesions using applicator, twice daily for 3 consecutive days

Titration Not applicable

Usual maintenance dose Repeat 3-day treatment cycle after 4-day rest period (total cycle = 7 days)

Maximum dose Maximum treated area ≤10 cm²; maximum volume 0.5 mL per application

Duration Up to 4–5 weekly treatment cycles

0.15% Cream Formulation:

Parameter Recommendation

Starting dose Apply thin layer to external wart lesions twice daily for 3 consecutive days

Titration Not applicable

Usual maintenance dose Repeat 3-day treatment cycle after 4-day rest period

Maximum dose Maximum treated area ≤10 cm² per application

Duration Up to 4–5 weekly treatment cycles

Treatment Cycle Structure:

text

Days 1–3: Apply twice daily → Days 4–7: Rest (no application) → Reassess → Repeat if needed

Key Clinical Notes:

• Apply only to wart tissue using cotton-tipped applicator or gloved finger

• Allow solution to dry completely before covering area

• Protect surrounding healthy skin with petroleum jelly if needed

• Response typically visible within 1–4 weeks

• Discontinue if no improvement after 4–5 cycles

• Refer to specialist for extensive disease or immunocompromised patients

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

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

Note: NOT indicated for common warts, plantar warts, or any neoplastic skin lesions.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

External Anogenital Warts (Adolescents ≥12 years)

Parameter Recommendation

Starting dose Same as adult dosing; apply to external warts twice daily for 3 days

Titration Not applicable

Usual maintenance dose Repeat weekly cycles as for adults

Maximum dose Smaller treatment area recommended; maximum 5 cm² per application

Duration Up to 4 weekly cycles with careful monitoring

Safety Monitoring Requirements:

• Application must be supervised by parent/guardian or healthcare provider

• Inspect treatment site before each cycle for ulceration or infection

• Higher risk of local irritation in paediatric skin

• Mandatory to rule out sexual abuse in prepubertal children with anogenital warts

Clear Statement: Not recommended in children below 12 years except under specialist paediatric dermatology or paediatric surgery supervision. Safety and efficacy not established in younger children.

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

Not applicable.

No dose adjustment required — topical application results in negligible systemic absorption.

Minimal systemic exposure with correct topical application.

• Known hypersensitivity to podophyllotoxin or podophyllin resin derivatives

• Pregnancy (absolute contraindication — embryotoxic and teratogenic)

• Application to mucosal surfaces (vaginal, cervical, urethral, intra-anal, oral mucosa)

• Bleeding, ulcerated, inflamed, or open wound lesions

• Concurrent use with other topical wart treatments on same lesion

• Moles, birthmarks, or atypical pigmented lesions (malignancy must be excluded)

• Avoid contact with eyes — severe corneal damage possible

• Avoid contact with healthy surrounding skin — causes irritation and erosion

• Not suitable for extensive wart involvement (>10 cm² total area)

• Immunocompromised patients — reduced efficacy; consider specialist referral

• Circumcised males — increased sensitivity of glans; apply cautiously

• Friable or highly vascular warts — increased absorption risk

• Prolonged use beyond recommended cycles — risk of systemic toxicity

• Advise abstinence from sexual contact during treatment period

• Wash hands thoroughly after each application

• Do not occlude treated area

Parameter Details

Risk category Contraindicated — teratogenic and embryotoxic in animal studies; potential systemic absorption

Trimester-specific Avoid throughout all trimesters

Preferred alternatives Cryotherapy (under specialist supervision); Trichloroacetic acid application (specialist only)

When may be used Should NOT be used in pregnancy under any circumstances

Monitoring If inadvertent exposure occurs — obstetric consultation; monitor fetal growth by ultrasound

Parameter Details

Compatibility Use with caution — limited human data available

Preferred alternatives Cryotherapy; Trichloroacetic acid; Imiquimod (if essential)

Expected milk levels Unknown; likely low with correct topical application

Application precautions Avoid application to breast or nipple area; prevent infant skin contact with treated areas

Infant monitoring Observe for oral mucosal lesions or skin irritation if inadvertent contact suspected

Parameter Recommendation

Starting dose Same as adult dosing

Titration Not applicable

Extra considerations Increased skin fragility — higher risk of local ulceration and erosion

Precautions Apply with extra care; use smaller treatment area if skin atrophic

Clinical note Rule out malignancy (SCC, BCC) in new-onset warty lesions in elderly before initiating treatment

No known systemic drug interactions — topical use with minimal systemic absorption.

Note: Avoid concurrent use with other topical keratolytic or cytotoxic agents on same treatment area due to additive local toxicity.

None documented with clinical significance.

• Local burning or stinging sensation (very common, >10%)

• Erythema at application site (very common, >10%)

• Localised pruritus

• Mild skin erosion or superficial desquamation

• Pain or tenderness at lesion site

• Oedema at application site

• Transient hypopigmentation or hyperpigmentation

Adverse Effect Action Required

Severe local ulceration or necrosis Discontinue immediately; wound care; consider antibiotics if infected

Extensive skin sloughing Discontinue; dermatology referral; supportive care

Secondary bacterial infection Discontinue; appropriate antibiotic therapy

Systemic toxicity (with excessive application/absorption): nausea, vomiting, diarrhoea, peripheral neuropathy, bone marrow suppression Immediate discontinuation; hospitalisation; supportive care

Ocular injury (accidental exposure) Immediate copious saline irrigation; urgent ophthalmology referral

During treatment (each cycle) Inspect for local ulceration, excessive erosion, secondary infection before reapplication

After 2–3 weeks Assess response; visible reduction in wart size expected

After 4–5 weeks If no improvement — discontinue; consider alternative therapy or specialist referral

Patient counselling Safe sexual practices; partner evaluation for STI; HPV vaccination discussion

• Wartec (0.15% cream)

• Condyline (0.5% solution)

• Podowart (0.5% solution)

• Podofilm (solution)

• Warticon (cream formulation)

0.5% solution (3–3.5 mL) ₹100–300

0.15% cream (5 g tube) ₹200–500

• NLEM Status: Not included in NLEM 2022

• Availability: Private sector predominantly; limited government supply

1. Confirm diagnosis first — Ensure clinical diagnosis of HPV-related condyloma; biopsy atypical, pigmented, or non-responsive lesions to rule out malignancy

1. External warts only — Never use for intra-vaginal, intra-urethral, cervical, or intra-anal warts; refer such cases to specialist for cryotherapy or surgical ablation

1. Patient-applied treatment — Suitable for patient self-application after proper demonstration; emphasise the 3-days-on, 4-days-off cycle

1. Overuse causes harm — Counsel patients that more application does NOT mean faster clearance; excess use leads to ulceration and delayed healing

1. STI screening essential — Screen for concurrent STIs (syphilis, HIV, chlamydia, gonorrhoea) in all patients with anogenital warts; discuss HPV vaccination for prevention

1. Alternative options — For larger warts, multiple lesions, or poor response, consider cryotherapy, electrocautery, or imiquimod cream

podophyllotoxin; anogenital warts; condyloma acuminata; HPV; topical cytotoxic; antimitotic; STI management; pregnancy-contraindicated; dermatology; genital warts

RxIndia v1.1 — 27 Apr 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• API Textbook of Medicine

• IADVL Guidelines on Management of Anogenital Warts

• NACO STI/RTI Treatment Guidelines

• AIIMS Department of Dermatology protocols

• WHO Guidelines on STI Management (supportive reference only)