Azelex

— THERAPEUTIC CATEGORIES —
  • Acne

Azelex Generic Name & Formulations

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

Metabolism

Hepatic.

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