| AZELAIC ACID
Classifications: antiacne; Therapeutic: antiacne
Pregnancy Category: B
20% cream; 15% gel
Azelaic acid is a naturally occurring dicarboxylic acid. Antimicrobial action is attributable to inhibition of the microbial
cellular protein synthesis. A normalization of keratinization of the follicle occurs and it reduces the number of acne lesions.
Reduces the number of inflammatory pustules and papules.
Mild to moderate inflammatory acne vulgaris, mild to moderate rosacea.
Hypersensitivity to any component in the drug.
Dark complexion, pregnancy (category B), lactation. Safety and efficacy in children <12 y are not established.
Route & Dosage
|Acne Vulgaris, Rosacea
Adult/Child (>12 y): Topical Apply thin film to clean and dry area b.i.d.
- Wash and dry skin thoroughly prior to application of drug.
- Apply by thoroughly massaging a thin film of the cream or gel into the affected area. Avoid occlusive dressing.
- Wash hands before and after application of cream or gel.
- Store at 15°30° C (59°86° F).
Adverse Effects (≥1%)Skin:
Pruritus, burning, stinging, tingling, erythema
, dryness, rash, peeling, irritation, contact dermatitis, vitiligo depigmentation,
Worsening of asthma
Approximately 4% absorbed through the skin. Onset:
48 wk. Distribution:
Into all tissues. Metabolism:
Partially by beta oxidation in liver. Elimination:
Primarily in urine. Half-Life:
Assessment & Drug Effects
- Assess for signs of hypopigmentation and report immediately.
- Monitor for sensitivity or severe irritation, which may warrant drug dosage reduction or discontinuation.
Patient & Family Education
- Learn proper application of cream or gel and avoid contact with eyes or mucous membranes.
- Wash eyes with copious amounts of water if contact with medication occurs.
- Note: Transient pruritus, burning, and stinging are common; however, severe skin irritation or hypopigmentation should be reported.