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Acne vulgaris: Topical: Cream 20%: Apply a thin film to the affected area(s) twice daily, in the morning and evening; may reduce to once daily if persistent skin irritation occurs. Improvement in condition is usually seen within 4 weeks.

Rosacea: Topical: Gel 15%: Apply a thin layer to the affected area(s) of the face twice daily, in the morning and evening; reassess if no improvement after 12 weeks of therapy. Dosing: Pediatric (For additional information see "Azelaic acid: Pediatric drug information" ) Acne vulgaris: Adolescents ≥12 years: Refer to adult dosing. Dosing: Geriatric Refer to adult dosing. Dosage Forms: U.S. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product Cream, topical: Azelex®: 20% (30 g, 50 g) [contains benzoic acid] Gel, topical: Finacea®: 15% (50 g) [contains benzoic acid] Finacea® Plus™: 15% (50 g [DSC]) [contains benzoic acid; packaged with cleanser and lotion] Generic Equivalent Available: U.S. No Administration Apply a thin film and gently massage into to clean, dry skin; wash hands following application. Avoid the use of occlusive dressings or wrappings. For gel formulation, cosmetics may be applied after the gel has dried. Use only mild soaps or soapless cleansing lotion for facial cleansing. Not intended for intravaginal, ophthalmic, or oral use. Use Azelex®: Treatment of mild-to-moderate inflammatory acne vulgaris Finacea®: Treatment of inflammatory papules and pustules of mild-to-moderate rosacea Adverse Reactions Significant >10%: Dermatologic: Burning/stinging/tingling (1% to 16%) 1% to 10%: Dermatologic: Pruritus (gel: 1% to 6%), dry skin/peeling/scaling/xerosis (≤5), erythema (≤2%), irritation (≤2%), acne (gel: ≤1%), contact dermatitis (≤1%), edema (gel: ≤1%) <1% (Limited to important or life-threatening): Asthma exacerbation, allergic reaction, dermatitis, herpes labialis exacerbation, hypertrichosis, iridocyclitis, rash, reddening, small depigmented spots, vitiligo depigmentation Contraindications Hypersensitivity to azelaic acid or any component of the formulation Warnings/Precautions

Concerns related to adverse effects: • Hypopigmentation: A few cases of hypopigmentation after use have been reported; monitor for changes in skin color. • Skin irritation: Discontinue use if severe skin irritation or sensitivity occurs.

Other warnings/precautions: • Appropriate use: For external use only; not for ophthalmic or vaginal use. Use of occlusive dressings or wrappings should be avoided. Metabolism/Transport Effects None known. Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) There are no known significant interactions. Pregnancy Risk Factor B ( show table ) Pregnancy Implications Adverse events were observed in animal reproduction studies following oral administration. Minimal systemic absorption (<4%) occurs following topical administration. Lactation Enters breast milk/use caution Breast-Feeding Considerations The manufacturer recommends that caution be exercised when administering azelaic acid to nursing women. Minimal systemic absorption (<4%) occurs following topical administration; a significant change from baseline azelaic acid levels in the milk is not expected. Dietary Considerations Gel: Foods and beverages that might provoke erythema, flushing, and blushing, such as spicy food, alcoholic beverages, and thermally hot drinks (including hot coffee and tea), should be avoided. Pricing: U.S. (Medi-Span®)

Gel (Finacea External) 15% (50 g): $232.18 International Brand Names Acnean (TW); Acnederm Medicated Lotion (MY, SG); Ami (TW); Av F Aza Acne Foundation (ID); Azalea (KP); Azeclear (HK); Azel (TW); Azelan (BR); Aziderm (IN); Cutacelan (AR, CO, EC, PE, VE); Finacea (AU, BG, FR, GB, IE, MX, SE); Skinoderm (IL); Skinorem (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Skinoren (AT, BE, CH, CZ, DE, DK, EE, ES, FI, GB, GR, HK, HN, IE, IT, MY, NO, NZ, PH, PK, PL, PT, RU, SE, TH, TR, TW, ZA); ZA (TW); Zelface (ID); Zeliris (ID) Mechanism of Action Azelaic acid is a dietary constituent normally found in whole grain cereals; can be formed endogenously. Exact mechanism is not known. In vitro , azelaic acid possesses antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis . May decrease microcomedo formation. Pharmacodynamics/Kinetics Absorption: Cream: ~3% to 5% penetrates stratum corneum; up to 10% found in epidermis and dermis; 4% systemic Half-life elimination: Topical: Healthy subjects: 12 hours Excretion: Urine (as unchanged drug) Use of UpToDate is subject to the Subscription and License Agreement . Topic 9038 Version 35.0 © 2013 UpToDate, Inc. All rights reserved. | Subscription and License Agreement | Release: 21.4 - C21.36 Licensed to: Southeast Alabama Med Ctr | Support Tag: [0604-58.240.98.179-9F9DC17642-S244013.14]