Azelaic acid: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Topical/Cutaneous
Acne vulgaris

Adult: As 20% cream or 15% gel: Apply thinly into the affected areas bid (morning and evening) after cleansing. Improvement may be detectable w/n 4 wk. Duration of treatment: Up to 6 mth.
Child: ≥12 yr Same as adult dose.

Topical/Cutaneous
Rosacea

Adult: As 15% gel: Apply thinly into the affected areas bid (morning and evening). Improvement occurs in 4-8 wk.
Child: ≥12 yr Same as adult dose.

Special Patient Group

Acne vulgaris:
Patients w/ sensitive skin: As 20% cream: Apply once daily (in the evening) for 1 wk then apply bid thereafter.

Special Precautions

Patient w/ sensitive skin. Not intended for application to broken, sunburnt or eczematous skin. Avoid use of occlusive dressing or wrappings. Pregnancy and lactation.

Adverse Reactions

Burning, erythema, stinging, pruritus, dryness and scaling, peeling, irritation, dermatitis, hypopigmentation, rash, and photosensitivity. Rarely, exacerbation of asthma.

Pregnancy Category (US FDA)

Topical: B

Monitoring Parameters

Monitor for hypopigmentation in patients w/ dark complexion.

Food Interaction

Avoid spicy foods, alcoholic beverages and hot drinks that might provoke erythema, flushing and blushing during treatment of rosacea.

Action

Description:
Mechanism of Action: Azelaic acid is a naturally-occurring aliphatic dicarboxylic acid that inhibits the growth of Propionibacterium acnes and reduces keratinisation, thus restricts the development of comedones.
Onset: W/n 4 wk.
Pharmacokinetics:
Absorption: Approx 4% absorbed systemically.
Distribution: Penetrates all layers of the skin.
Metabolism: Metabolised via β-oxidation into short-chained dicarboxylic acids (C₇, C₅).
Excretion: Via urine (mainly as unchanged drug and some as dicarboxylic acids). Half-life: 12 hr.

Chemical Structure

Storage

Store between 15-30°C.

MIMS Class

Acne Treatment Preparations

ATC Classification

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

References

Anon. Azelaic Acid. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/06/2016.

Azelex Cream (Allergan, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 03/06/2016.

Buckingham R (ed). Azelaic Acid. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/06/2016.

Joint Formulary Committee. Azelaic Acid. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/06/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Azelaic Acid (Topical). AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 03/06/2016.

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