Azelaic Acid

Pronunciation: aze-eh-LAY-ik AH-sid
Class: Antibiotic agent

Trade Names

Azelex
- Cream 20%

Finacea
- Gel 15%

Pharmacology

Mechanism of action is unknown; however, inhibition of microbial cellular protein synthesis may be involved.

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Pharmacokinetics

Absorption

Approximately 4% of topically applied dose is systemically absorbed.

Distribution

Approximately 3% to 5% penetrates into the stratum corneum and up to 10% into the epidermis and dermis.

Mean plasma concentration in rosacea patients ranges from 42 to 63.1 ng/mL after at least 8 wk of treatment.

Elimination

Primarily unchanged in the urine. The t _½ after topical application is approximately 12 h.

Primarily unchanged in the urine.

Indications and Usage

Topical treatment of mild to moderate inflammatory acne vulgaris (cream); topical treatment of papules and pustules of mild to moderate rosacea.

Contraindications

Standard considerations.

Dosage and Administration

Topical After washing and patting dry, gently but thoroughly massage a thin film of cream or gel into the affected areas twice daily, in the morning and evening. In the majority of patients with inflammatory lesions, improvement of the condition occurs within 4 wk.

Storage/Stability

Store cream or gel at controlled room temperature (59° to 86°F). Keep tube tightly capped and protect from freezing.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Vitiligo depigmentation; small depigmented spots; hypertrichosis; reddening (signs of keratosis pilaris); exacerbation of recurrent herpes labialis (rare).

Pruritus, burning, stinging, tingling (1% to 5%); erythema, dryness, rash, peeling, irritation, dermatitis, contact dermatitis (less than 1%).

Burning, stinging, tingling (20%); pruritus (7%); scaling, dry skin, xerosis (6%); erythema, irritation (2%); contact dermatitis, acne, seborrhea (1%).

Respiratory

Worsening of asthma.

Miscellaneous

Edema (1%); allergic reactions.

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 12 yr of age.

Sensitivity/Irritation

Discontinue if sensitivity or severe irritation develops.

Patient Information

• Advise patient that medication is applied topically to skin lesions twice daily, morning and evening.
• Teach patient with acne proper technique for applying cream: wash hands; thoroughly wash and pat area(s) to be treated dry, then apply a thin film of cream to cover skin areas with acne lesions. Gently massage cream into skin. Wash hands after applying medication.
• Advise patient with acne that improvement may not be seen for at least 4 wk and to continue using the medication.
• Teach patient with rosacea proper technique for applying gel: wash hands; cleanse affected area(s) with mild soap or soapless cleansing solution then gently pat dry; apply a thin film of gel to affected area(s) and gently massage into the skin. Wash hands after applying medication.
• Instruct patient using gel to avoid concurrent use of topical alcoholic cleansers, tinctures and astringents, abrasives and peeling agents, as well as any food or beverage that might cause redness, flushing, or blushing (eg, spicy food, alcoholic beverages, hot drinks such as coffee or tea).
• Caution patient not to cover treated areas with bandages or dressings.
• Warn patient that applying medication more often than prescribed or in excessive quantities will not produce more rapid improvement or better results but will result in greater side effects such as redness, scaling, and discomfort.
• Advise patient that if an application is missed, not to try to make it up but to return to normal application schedule as soon as possible.
• Warn patient to avoid contact with the eyes, eyelids, lips, and mucous membranes.
• Advise patient that if cream or gel comes in contact with the eyes to wash eyes with large amounts of cool water and to contact health care provider if eye irritation persists.
• Advise patient with dark complexion to report any change in skin color to health care provider.
• Advise patient that local stinging, burning, itching, and tingling are the most common side effects and to notify health care provider if bothersome.
• Advise patient that if severe skin reactions occur to stop using the medication and contact health care provider.
• Advise patient to talk to health care provider before using any other topical agents (eg, medicated soaps, astringents, cosmetics, other acne products) on treated skin.
• Advise patient that follow-up visits to examine the skin lesions may be necessary and to keep appointments.

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