Azelex Generic Name & Formulations
Legal Class
Rx
General Description
Azelaic acid 20%; crm.
Pharmacological Class
Antibacterial/antikeratinizing agent.
How Supplied
Crm—30g, 50g
Manufacturer
Azelex Indications
Indications
Mild to moderate inflammatory acne vulgaris.
Azelex Dosage and Administration
Adult
Wash and dry skin. Massage thin film gently into affected areas twice daily (AM and PM). Wash hands after use. If persistent irritation occurs, may decrease to once daily.
Children
Not recommended.
Azelex Contraindications
Not Applicable
Azelex Boxed Warnings
Not Applicable
Azelex Warnings/Precautions
Warnings/Precautions
Monitor patients with dark complexions for hypopigmentation. Discontinue if sensitivity or severe irritation develops. Avoid mouth, eyes, other mucous membranes, and occlusive dressings. Pregnancy (Cat.B). Nursing mothers.
Azelex Pharmacokinetics
Elimination
Renal. Half-life: 12 hours.
Azelex Interactions
Not Applicable
Azelex Adverse Reactions
Adverse Reactions
Pruritus, burning, stinging, tingling; rare: exacerbation of asthma or of recurrent herpes labialis, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening.
Azelex Clinical Trials
See Literature
Azelex Note
Not Applicable
Azelex Patient Counseling
See Literature