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Authoritative Clinical Reference
Schedule H
Topical
INDICATIONS + DOSING ā FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
ā¶ 1. Acne Vulgaris (mild to moderate ā comedonal and inflammatory)
Apply to affected areas after cleansing; avoid broken skin, eyes, and mucous membranes.
Parameter Recommendation
Starting dose 0.05% gel or cream applied once daily at bedtime
Titration May increase to 0.1% after 2ā4 weeks if tolerated and required
Usual maintenance dose 0.05ā0.1% applied once daily or alternate nights
Maximum dose 0.1% once daily; reduce frequency if irritation occurs
Clinical Notes:
ā¶ 2. Plaque Psoriasis (localized, stable plaques)
Apply thin film to affected lesions only; avoid face, flexures, and intertriginous areas.
Parameter Recommendation
Starting dose 0.05% gel or cream applied once daily at bedtime
Titration May increase to 0.1% if tolerated after 2ā4 weeks
Usual maintenance dose 0.05ā0.1% once daily application
Maximum dose 0.1% once daily; do not apply to >20% body surface area
Clinical Notes:
Secondary Indications ā Adults (Off-label, if any)
Indication Dose Duration Notes
Photoaging (fine wrinkles, mottled hyperpigmentation) ā OFF-LABEL 0.1% cream applied once daily at bedtime Up to 24 weeks Specialist only; evidence from Western RCTs; limited Indian practice data
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
ā¶ 1. Acne Vulgaris ā Age ā„12 years
Parameter Recommendation
Starting dose 0.05% gel or cream once daily at bedtime
Titration Increase to 0.1% after 4 weeks if tolerated and required
Usual maintenance dose 0.05ā0.1% once daily or alternate nights
Maximum dose 0.1% once daily
Clinical Notes:
ā¶ 2. Plaque Psoriasis ā Age ā„12 years
Parameter Recommendation
Starting dose 0.05% gel or cream once daily at bedtime
Titration May increase to 0.1% if tolerated
Usual maintenance dose 0.05ā0.1% once daily
Maximum dose 0.1% once daily; limit to localized lesions only
Clinical Notes:
Secondary Indications ā Paediatric Doses (Off-label, if any)
Not applicable ā no established off-label paediatric indications
ā ļø Not recommended below 12 years of age. Use below age 12 only under strict dermatologist supervision with clear clinical justification.
No adjustment required ā minimal systemic absorption with topical application
| Severity | Recommendation |
|---|---|
| Mild impairment | No adjustment required |
| Moderate impairment | No adjustment required; use with caution |
| Severe impairment | Use with caution; limited data available; restrict application area |
Parameter Recommendation
Overall safety Contraindicated ā known teratogen (systemic retinoid class effect)
When to use Do not use under any circumstance during pregnancy
Preferred alternatives Azelaic acid, benzoyl peroxide, topical erythromycin/clindamycin for acne
Contraception requirement Effective contraception mandatory in women of reproductive age; confirm negative pregnancy test before starting
Monitoring Not applicable ā avoid use entirely
Parameter Recommendation
Compatible with breastfeeding Use with caution ā limited data on excretion in milk
Drug levels in milk Likely low due to minimal systemic absorption
Preferred alternatives Azelaic acid, benzoyl peroxide if extensive application or prolonged use needed
Precautions Avoid application on or near breast; prevent infant skin contact with treated areas
Infant monitoring Observe for skin irritation if accidental exposure
Parameter Recommendation
Starting dose 0.05% gel or cream once daily or alternate nights
Titration Slower titration; increase concentration only if well-tolerated
Special considerations Thinner, more fragile skin ā increased irritation and dryness risk; monitor closely
Interacting Drug/Agent Effect Management
Systemic photosensitising drugs (tetracyclines, fluoroquinolones, thiazides) Additive phototoxicity risk Avoid concurrent use; if unavoidable, strict photoprotection mandatory
Other topical retinoids Excessive irritation and desquamation Avoid concurrent use
Interacting Drug/Agent Effect Management
Benzoyl peroxide Potential for additive irritation Stagger application times (benzoyl peroxide in morning, tazarotene at night)
Topical salicylic acid Increased irritation and peeling Avoid concurrent application; stagger if both required
Topical corticosteroids May reduce irritation; commonly combined in psoriasis Sequential or combination use acceptable under supervision
Alpha-hydroxy acids (AHAs) Enhanced skin irritation Avoid concurrent use or stagger applications
Adverse Effect Action Required
Severe local irritation with blistering/vesiculation Discontinue immediately; symptomatic treatment
Teratogenicity (if used in pregnancy) Systemic absorption may cause fetal malformations ā absolute contraindication
Severe photosensitivity reaction Discontinue; avoid sun exposure; supportive care
Contact dermatitis (allergic) Discontinue; consider patch testing
Phase Parameters
Baseline Pregnancy test (mandatory in women of childbearing potential); document skin condition severity
First 2ā4 weeks Assess for local irritation (erythema, peeling, burning); adjust frequency if needed
At 8ā12 weeks Evaluate clinical efficacy; decide on continuation or dose adjustment
Long-term Verify ongoing contraception compliance; periodic skin assessment; sun protection adherence
| Formulation | Approximate Price (per tablet) |
|---|
0.05% gel/cream (15 g tube) ā¹180āā¹260
0.1% gel/cream (15 g tube) ā¹220āā¹350
tazarotene; topical retinoid; acne vulgaris; plaque psoriasis; dermatology; pregnancy-contraindicated; teratogenic; photosensitivity; comedonal acne; Schedule H
RxIndia v1.0 ā 27 Apr 2025
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