Azelaic Acid (Topical) (Monograph)

Brand names: Azelex, Finacea
Drug class: Antibacterials

Medically reviewed by Drugs.com on May 10, 2024. Written by ASHP.

Introduction

Antibacterial and antiproliferative agent; naturally occurring aliphatic dicarboxylic acid.

Uses for Azelaic Acid (Topical)

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 (Topical) 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 (Topical)

Contraindications

• Known hypersensitivity to azelaic acid or any of its components.

• Known hypersensitivity to propylene glycol (for gel formulation).

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 (Topical) 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

• Exact mechanism of action for treatment of acne vulgaris not fully elucidated; however, effect appears to result partially from antibacterial activity.

• Inhibits growth of susceptible organisms (principally Propionibacterium acnes) on skin by inhibiting protein synthesis.

• Usually bacteriostatic; may be bactericidal in high concentrations against P. acnes and Staphylococcus epidermidis

• May inhibit follicular keratinization, which may prevent development or maintenance of comedones.

• Exhibits antiproliferative effects against hyperactive and abnormal melanocytes but does not exhibit an appreciable depigmenting effect on normally pigmented skin.

• Exact mechanism of action for treatment of rosacea is unknown.

Advice to Patients

• Importance of using for full prescribed treatment period.

• Importance of avoiding contact with eyes, mouth, or other mucous membranes. If contact with eyes occurs, wash eyes with large amounts of water and contact clinician if eye irritation persists.

• Importance of discontinuing therapy and consulting clinician if severe local irritation, severe itching, and/or rash occurs.

• Importance of washing hands following application.

• Importance of avoiding occlusive dressings.

• Importance of reporting abnormal changes in skin color to a clinician.

• Importance of patients being treated for rosacea avoiding foods or beverages that may cause flushing or blushing, such as spicy foods, alcoholic beverages, and thermally hot drinks.

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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.

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Frequently asked questions

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