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Azelaic Acid (Monograph)

Brand names: Azelex, Finacea
Drug class: Skin and Mucous Membrane Agents, Miscellaneous
ATC class: D10AX03
VA class: DE752
Chemical name: Nonanedioic acid
Molecular formula: C9H16O4
CAS number: 123-99-9

Introduction

Antibacterial and antiproliferative agent; naturally occurring aliphatic dicarboxylic acid.

Uses for Azelaic Acid

Acne

Treatment of mild to moderate inflammatory acne vulgaris.

Not for the treatment of noninflammatory acne vulgaris.

Rosacea

Treatment of inflammatory lesions (papules and pustules) associated with mild to moderate rosacea.

Treatment of erythema in rosacea without papules and pustules has not been evaluated.

Azelaic Acid Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 20% cream or 15% gel.

For dermatologic use only; avoid contact with eyes, mouth, or other mucous membranes. If contact with the eye(s) occurs, wash with large amounts of water; consult clinician if ocular irritation persists.

Wash skin and pat dry before applying cream or gel to affected areas. Use only very mild soaps or soapless cleansing lotions before applying gel for treatment of rosacea.

Apply in a thin layer of cream or gel and rub gently into affected areas. Wash hands after application.

If irritation is excessive or persists in patients with acne, decrease frequency of application to once daily or discontinue until manifestations subside.

If irritation is excessive or persists in patients with rosacea, discontinue therapy.

Do not use occlusive dressings or wrappings.

Allow gel to dry before applying cosmetics to skin.

Dosage

Pediatric Patients

Acne
Topical

Adolescents ≥12 years of age: Apply 20% cream in a thin film to affected areas twice daily (morning and evening).

Improvement usually is detectable within 1–2 months of initiating therapy; however, maximum benefit generally requires more prolonged treatment.

Usual duration of therapy is ≤6 months; however, therapy for ≥1 year has been required for control of individual lesions and repeat courses have been used for recurrences.

Adults

Acne
Topical

Apply 20% cream in a thin film to affected areas twice daily (morning and evening).

Improvement usually is detectable within 1–2 months of initiating therapy; however, maximum benefit generally requires more prolonged treatment.

Usual duration of therapy is ≤6 months; however, therapy for ≥1 year has been required for control of individual lesions and repeat courses have been used for recurrences.

Rosacea
Topical

Apply 15% gel in a thin film to affected area twice daily (morning and evening).

Safety and efficacy of therapy with gel for >12 weeks not established.

Prescribing Limits

Pediatric Patients

Acne
Topical

Adolescents ≥12 years of age: Some clinicians suggest maximum 6 months of therapy; however, ≥1 year of therapy has been used in for control of individual lesions.

Adults

Acne
Topical

Some clinicians suggest maximum 6 months of therapy; however, ≥1 year of therapy has been used in for control of individual lesions.

Rosacea
Topical

Safety and efficacy of therapy with gel for >12 weeks not established.

Special Populations

No special population dosage recommendations at this time.

Cautions for Azelaic Acid

Contraindications

Warnings/Precautions

Warnings

Hypopigmentation

Hypopigmentation reported rarely; monitor patients with dark complexions for early signs of hypopigmentation during therapy.

General Precautions

Dermatologic Effects

Possible skin irritation (e.g., pruritus, burning, stinging) during initial weeks of therapy. If sensitivity or severe irritation develops, discontinue therapy, contact clinician, and institute appropriate therapy.

Specific Populations

Pregnancy

Category B.

Lactation

Minimally distributed into milk following topical application. Caution if used in nursing women.

Pediatric Use

Safety and efficacy of 20% cream not established in children <12 years of age.

Safety and efficacy of 15% gel not established.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.

Common Adverse Effects

20% cream: Pruritus, burning, stinging, tingling.

15% gel: Pruritus, burning, stinging, tingling, scaling, dryness.

Drug Interactions

No formal interaction studies to date.

Azelaic Acid Pharmacokinetics

Absorption

Minimally absorbed following topical administration.

Elimination

Metabolism

Minimally metabolized following topical application; undergoes some β-oxidation to shorter chain dicarboxylic acids.

Elimination Route

Excreted principally in urine as unchanged drug.

Half-life

12 hours following topical application.

Stability

Storage

Topical

Cream

15–30°C; do not freeze. Keep container on its side.

Gel

25°C (may be exposed to 15–30°C).

Actions

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Azelaic Acid

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

20%

Azelex (with propylene glycol)

Allergan

Gel

15%

Finacea (with propylene glycol)

Berlex

AHFS DI Essentials™. © Copyright 2024, Selected Revisions May 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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Frequently asked questions