Azelaic Acid Schedule (India)

Not Scheduled (OTC)

Azelaic Acid Routes

Topical

Azelaic Acid Formulations

Cream: 10%, 20%

Gel: 15%, 20%

Azelaic Acid Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

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

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

Azelaic Acid Paediatric indications

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.

Azelaic Acid Renal Adjustments

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

Safe in all stages of chronic kidney disease.

Azelaic Acid Hepatic adjustment

Severity	Recommendation
Mild impairment	No dose adjustment required
Moderate impairment	No dose adjustment required
Severe impairment	No dose adjustment required — minimal systemic exposure with topical application

Azelaic Acid Contraindications

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

Azelaic Acid Cautions

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

Azelaic Acid Pregnancy

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

Azelaic Acid Lactation

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

Azelaic Acid Elderly

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

Azelaic Acid Major drug interactions

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

Azelaic Acid Moderate drug interactions

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

Azelaic Acid Common Adverse effects

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.

Azelaic Acid Serious Adverse effects

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

Azelaic Acid Monitoring requirements

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

Azelaic Acid Brands in India

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.

Azelaic Acid Price range (INR)

Formulation	Approximate Price (per tablet)
10% cream (15–20 g)	₹100–180
15% gel (15–20 g)	₹120–200
20% cream (15–20 g)	₹150–250

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

Azelaic Acid Clinical pearls

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 Tags

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

Azelaic Acid Version

RxIndia v1.0 — 05 May 2025

Azelaic Acid Reference

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

RxIndia

The Drug Registry

Azelaic Acid