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- Anchoic Acid
- Lepargylic Acid
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Azelex: 20% (30 g, 50 g)
Finacea: 15% (50 g) [contains benzoic acid, cetostearyl alcohol, polysorbate 80, propylene glycol]
Finacea: 15% (50 g) [contains benzoic acid, disodium edta, polysorbate 80, propylene glycol]
Brand Names: U.S.
- Topical Skin Product, Acne
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.
Cream: ~3% to 5% penetrates stratum corneum; up to 10% found in epidermis and dermis; 4% systemic
Negligible after topical application; some beta-oxidation to shorter chain dicarboxylic acids
Urine (primarily as unchanged drug)
Onset of Action
Cream: Within 4 weeks
Topical: Healthy subjects: 12 hours
Use: Labeled Indications
Acne vulgaris (cream): Treatment of mild to moderate inflammatory acne vulgaris.
Rosacea (foam, gel): Treatment of inflammatory papules and pustules of mild to moderate rosacea.
Limitations of use: Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
Cream: Hypersensitivity to azelaic acid or any component of the formulation
Foam, gel: There are no contraindications listed in the manufacturer’s labeling
Acne vulgaris: Children ≥12 years, Adolescents, and Adults: 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: Adults: Topical: Gel 15% and foam 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.
Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
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 foam and gel formulations, cosmetics may be applied after the foam or gel has dried. Use only mild soaps or soapless cleansing lotion for facial cleansing. Not intended for intravaginal, ophthalmic, or oral use.
Foam: Shake well before use.
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.
Store at 15°C to 30°C (59°F to 86°F); do not freeze. Store cream on its side.
Foam: Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Flammable; avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 49°C (120°F). Discard 8 weeks after opening.
There are no known significant interactions.
>10%: Dermatologic: Burning sensation of skin (≤16%), stinging of skin (≤16%), tingling of skin (≤16%)
1% to 10%:
Dermatologic: Pruritus (1% to 6%), erythema (≤2%), skin irritation (≤2%), acne (gel: ≤1%), contact dermatitis (≤1%), desquamation (≤1%), xeroderma (≤1%), xerosis (≤1%)
Local: Application site pain (6%), application site pruritus (3%)
<1% (Limited to important or life-threatening): Edema, exacerbation of asthma, exacerbation of herpes labialis, hypersensitivity reaction, hypertrichosis, hypopigmentation, iridocyclitis, vitiligo
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions have been reported; discontinue use if signs/symptoms occur.
• Hypopigmentation: A few cases of hypopigmentation after use have been reported; monitor for changes in skin color, especially in patients with dark complexions.
• Skin irritation: Skin irritation (eg, pruritus, burning, stinging) may occur, usually during the first weeks of therapy. Discontinue use if severe skin irritation or sensitivity occurs.
Dosage form specific issues:
• Foam: Contains flammable propellants. Avoid fire, flame and smoking during and immediately following use.
• Gel: Reassess use if no improvement is seen after 12 weeks of therapy.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
• Appropriate use: For external use only; not for oral, ophthalmic, or vaginal use; avoid contact with the eyes, mouth, and other mucous membranes. Use of occlusive dressings or wrappings should be avoided.
Pregnancy Risk Factor
Adverse events have been observed in animal reproduction studies following oral administration. The amount of azelaic acid available systemically following topical administration is minimal (<4%).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Have patient report immediately to prescriber severe skin irritation or skin discoloration (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.