AZELAIC ACID
| AZELAIC ACID (a'ze-laic) Azelex, Finacea Classifications: antiacne; Therapeutic: antiacne Prototype: Isotretinoin Pregnancy Category: B |
Availability
20% cream; 15% gel
Action
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.
Therapeutic Effect
Reduces the number of inflammatory pustules and papules.
Uses
Mild to moderate inflammatory acne vulgaris, mild to moderate rosacea.
Contraindications
Hypersensitivity to any component in the drug.
Cautious Use
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. |
Administration
Topical- 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, hypertrichosis. Other: Worsening of asthma.Pharmacokinetics
Absorption: Approximately 4% absorbed through the skin. Onset: 4–8 wk. Distribution: Into all tissues. Metabolism: Partially by beta oxidation in liver. Elimination: Primarily in urine. Half-Life: 12 h.Nursing Implications
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.
Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; 
Canadian drug name; 
Prototype drug