Hypersensitivity.

Patient with asthma or sensitive skin. Avoid the use of other topical products that may cause skin irritation (e.g. alcoholic cleansers, tinctures, astringents, abrasives, peeling agents) when using the gel for the treatment of rosacea. Children. Pregnancy and lactation.

Significant: Hypersensitivity reactions (e.g. angioedema, dyspnoea, eye or facial swelling, skin reactions, urticaria); hypopigmentation, local skin irritation (e.g. burning, pruritus, stinging); asthma exacerbation.
General disorders and administration site conditions: Application site pain, dryness, exfoliation, erythema, and discolouration.

Avoid contact with mouth, eyes, or other mucous membranes. Do not use occlusive dressing or wrappings unless directed by the doctor.

Regularly monitor for skin sensitivity, severe irritation, or hypopigmentation (particularly in patients with dark complexions) during therapy.

Certain foods and beverages (e.g. spicy food, alcoholic beverages, thermally hot drinks, including hot coffee and tea) may provoke blushing, flushing, and erythema; avoid during treatment of rosacea.

Description:
Mechanism of Action: Azelaic acid is a naturally occurring aliphatic dicarboxylic acid that exhibits antiproliferative and antibacterial properties. Its exact mechanism of action is unknown, but studies show that it inhibits the proliferation of keratocytes and normalises the disturbed terminal epidermal differentiation processes in acne. Additionally, azelaic acid inhibits protein synthesis, thereby preventing the growth of susceptible organisms on the skin surface.
Onset: Within 4 weeks (cream).
Pharmacokinetics:
Absorption: Absorbed systemically (approx 4%).
Metabolism: Metabolised via β-oxidation into short-chained dicarboxylic acids.
Excretion: Via urine (as unchanged drug). Elimination half-life: 12 hours.

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 2266, Azelaic Acid. https://pubchem.ncbi.nlm.nih.gov/compound/Azelaic-Acid. Accessed Mar. 26, 2025.

Store between 15-30°C.

Acne Treatment Preparations

D10AX03 - azelaic acid ; Belongs to the class of other topical preparations used in the treatment of acne.

Anon. Azelaic Acid. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 10/02/2025.

Azelaic Acid. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/02/2025.

Azelex Cream (Almirall, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/02/2025.

Brayfield A, Cadart C (eds). Azelaic Acid. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2025.

Finacea 15% Gel (Leo Laboratories Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/02/2025.

Finacea Gel (Leo Pharma Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/02/2025.

Joint Formulary Committee. Azelaic Acid. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2025.

LEO Pharma Limited. Skinoren 20% Cream data sheet March 2020. Medsafe. http://www.medsafe.govt.nz. Accessed 20/03/2025.

Skinoren 20% Cream (Leo Laboratories Limited). MHRA. https://products.mhra.gov.uk. Accessed 10/02/2025.

Skinoren Cream (DKSH Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/02/2025.