Not Scheduled (OTC)

Topical

• Cream: 10%, 20%

• Gel: 15%, 20%

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acne Vulgaris (Inflammatory and Comedonal)

Parameter Details

Starting dose Apply thin layer to affected area twice daily (morning and evening) after cleansing

Titration Not applicable; if irritation occurs, reduce to once daily initially

Usual maintenance dose Twice daily application

Maximum dose Application to entire affected area; limited by surface area treated

Clinical Notes:

• Improvement typically observed in 4–8 weeks; continue for 12 weeks for optimal response

• May combine with topical retinoid, benzoyl peroxide, or topical antibiotics for enhanced efficacy

• Suitable for mild-to-moderate acne; less effective for severe nodulocystic acne

• Gel formulation (15%) preferred for oily skin; cream (20%) for normal/dry skin

1. Melasma (Epidermal or Mixed Type)

Parameter Details

Starting dose Apply thin film of 20% cream to hyperpigmented patches twice daily

Titration Not applicable

Usual maintenance dose Twice daily application

Maximum dose Application to affected patches only; avoid uninvolved skin

Duration Minimum 8–12 weeks; continue up to 6 months for optimal response

Clinical Notes:

• More effective when combined with strict sun protection (SPF 30+) and adjunctive depigmenting agents

• Safer alternative to hydroquinone for long-term use and during pregnancy

• Visible improvement usually noted after 8–12 weeks of consistent use

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Remarks

Papulopustular rosacea — OFF-LABEL 15% gel applied twice daily to affected facial areas 12–16 weeks; assess response Specialist only (Dermatologist); international RCTs demonstrate efficacy; not standard in IADVL guidelines

Post-inflammatory hyperpigmentation — OFF-LABEL 15–20% cream/gel applied twice daily 8–12 weeks Specialist supervision recommended; Indian dermatology practice; may combine with other depigmenting agents

PAEDIATRIC DOSING (Specialist Only)

Primary Indication: Acne Vulgaris

Age Dose Application Duration

≥12 years Apply thin layer of 15% gel or 20% cream to affected area twice daily After cleansing; avoid eye and mucous membrane contact 8–12 weeks; reassess

Monitoring:

• Skin irritation (burning, erythema)

• Treatment response at 4–8 weeks

Clinical Notes:

• Use gel formulation preferentially in adolescents with oily skin

• Counsel regarding temporary initial stinging/burning

Secondary Indications — Paediatric (Off-label)

Not applicable — No established off-label paediatric indications with adequate evidence.

⚠️ Not recommended below 12 years of age. Safety and efficacy not established in children <12 years. Use only under dermatologist supervision if considered in younger children.

No dose adjustment required — systemic absorption following topical application is minimal (<4% of applied dose absorbed).

Safe in all stages of chronic kidney disease.

• Known hypersensitivity to azelaic acid or any formulation excipient (propylene glycol, benzoic acid)

• Avoid contact with eyes, mouth, lips, and mucous membranes — may cause severe irritation

• History of hypersensitivity reactions to other topical agents

• Initial irritation (burning, stinging, tingling) common — counsel patients to continue if mild; reduce frequency if moderate

• Patients with darker skin types (Fitzpatrick IV–VI) — monitor for hypopigmentation with prolonged use

• Broken or inflamed skin — may cause increased absorption and irritation

• Avoid concomitant use of harsh cleansers, alcohol-based products, or astringents

Parameter Details

Safety Category Generally considered safe; minimal systemic absorption (<4%); Category B equivalent

Preferred alternatives Azelaic acid is preferred over hydroquinone, retinoids, and salicylic acid during pregnancy for acne and melasma

When to use May be used throughout pregnancy for acne and melasma when benefit justified; dermatology input recommended

Monitoring Local skin irritation; reinforce photoprotection

Parameter Details

Compatibility Compatible with breastfeeding

Drug levels in milk Negligible — azelaic acid is a naturally occurring dicarboxylic acid present in foods; minimal systemic absorption

Preferred alternatives Azelaic acid is a preferred topical agent during lactation

Infant monitoring No routine monitoring required; avoid application to breast/nipple area

Parameter Recommendation

Starting dose Standard adult application (twice daily)

Titration Not applicable

Special considerations Limited data in elderly; increased skin dryness may occur; monitor for excessive irritation or dryness

Additional risks No specific systemic concerns due to minimal absorption

No clinically significant major drug interactions documented with topical azelaic acid due to minimal systemic absorption.

Drug/Agent Interaction Recommendation

Topical retinoids (tretinoin, adapalene) Additive local irritation (erythema, peeling, dryness) Stagger application times (morning/evening alternation); start retinoid at lower frequency

Benzoyl peroxide Additive drying and irritation Use at different times of day; monitor for excessive dryness

Topical alpha-hydroxy acids (glycolic acid, lactic acid) Enhanced irritation Avoid concurrent application; use on alternate days if combination desired

Alcohol-containing cosmetics, astringents Increased skin irritation and dryness Avoid simultaneous use

• Burning or stinging at application site (most common; usually transient)

• Pruritus

• Erythema

• Dryness

• Scaling or peeling

• Tingling sensation

Note: Local adverse effects typically mild and diminish with continued use; most patients develop tolerance within 2–4 weeks.

• Severe allergic contact dermatitis — discontinue immediately; may require topical corticosteroid treatment

• Angioedema — rare; discontinue immediately; seek emergency care if facial/airway involvement

• Hypopigmentation — rare; may occur with prolonged use, especially in darker skin types; usually reversible on discontinuation

Phase Parameters

Baseline Clinical examination of affected skin; document severity; pregnancy status if relevant

After initiation (2–4 weeks) Assess local irritation; tolerance development; early response

Long-term (8–12 weeks and beyond) Treatment response; monitor for hypopigmentation (especially darker skin); assess need for continuation or combination therapy

• Aziderm® (Micro Labs) — 10% cream, 20% cream, 15% gel

• Ezanic® (Intas) — 15% gel, 20% cream

• Azisoft® (Sun Pharma) — 20% cream

• Skinlite® (Sun Pharma) — 20% cream

• Acnelak® (Curatio) — 20% cream

• Azacne® (Ajanta) — 20% cream

Note: Several brands available as FDCs with hydroquinone, tretinoin, or other depigmenting agents.

Note: Not included in NLEM 2022; not NPPA price-controlled; available in both private and government supply.

• Multimodal action: Azelaic acid is keratolytic, antibacterial (against P. acnes), anti-inflammatory, and inhibits tyrosinase — useful for both acne and pigmentary disorders

• Pregnancy/lactation safety: Preferred topical agent for acne and melasma during pregnancy and breastfeeding — safer alternative to hydroquinone, retinoids, and salicylic acid

• Tolerance development: Initial burning/stinging is common but typically resolves within 2–4 weeks — counsel patients to persist with treatment

• Skin type selection: Gel formulation (15%) preferred for oily/combination skin; cream formulation (20%) better tolerated on dry/sensitive skin

• Sun protection essential: When treating melasma, emphasise strict photoprotection (SPF 30+ sunscreen, physical barriers) — efficacy significantly reduced without sun protection

• Delayed response: Takes 6–8 weeks minimum for visible improvement — set realistic expectations to ensure adherence

azelaic acid; acne vulgaris; melasma; topical therapy; dicarboxylic acid; pregnancy-safe; lactation-safe; hyperpigmentation; rosacea (off-label); dermatology; OTC India

RxIndia v1.0 — 05 May 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• AIIMS Drug Formulary

• IADVL Guidelines for Acne Vulgaris and Melasma

• API Textbook of Medicine — Dermatological Disorders

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• International RCTs — off-label rosacea indication