Azelaic Acid 20% topical

Azelaic Acid 20% topical is a topical medication used in the treatment of acne (pimples) and rosacea. It effectively relieves symptoms such as lumps, redness and swelling by killing the acne-causing bacteria. Azelaic Acid 20% topical is for external use only. Apply a thin layer to the affected areas twice daily (morning and evening). Improvement may be detectable within 4 weeks. Duration of treatment: up to 6 months.

Common side effects include application site reactions like burning, irritation, itching, and redness. These are usually mild and regress as treatment continues.

• Mild to moderate inflammatory acne vulgaris
• Rosacea

Azelaic acid has been shown to possess antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The antimicrobial action may be attributable to the inhibition of microbial cellular protein synthesis. A normalization of keratinization leading to an anticomedonal effect of Azelaic acid may also contribute to its clinical activity.

The mechanism of action in the treatment of rosacea is unknown.

Azelaic acid inhibits the growth of susceptible bacteria (especially Propionibacterium acnes) by disrupting cellular protein synthesis. It also normalizes follicular keratinization, reducing comedone formation and decreasing skin inflammation and redness.

Adult:

• Acne vulgaris: 20% cream, apply a thin layer to affected areas twice daily (morning and evening). Improvement may be detectable within 4 weeks. Duration of treatment: up to 6 months.
• Rosacea: Apply to affected areas twice daily (morning and evening). Improvement occurs in 4-8 weeks.

Pediatric (>12 years): Same as adult dose.

Pediatric (<12 years): Safety and efficacy not established.

For external use only. Clean and dry the affected area. Apply a thin layer and gently massage into the affected areas twice daily. Wash hands after application (unless hands are the affected area). Avoid contact with eyes, mouth, or other mucous membranes.

If you miss a dose, skip it and continue with your normal schedule. Do not double the dose.

• Application site burning
• Erythema (redness)
• Itching
• Scaling
• Dryness

In most cases, these reactions are mild and regress as treatment continues.

• Apply only to affected areas
• If severe irritation or allergy occurs, discontinue use and consult your doctor
• For sensitive skin, apply once daily for the first week, then proceed to twice daily
• Avoid contact with eyes; if contact occurs, rinse thoroughly with plenty of water
• Consult your doctor if pregnant or breastfeeding

• Hypersensitivity to azelaic acid or any component

No formal studies of the interaction of Azelaic Acid with other drugs have been conducted.

No food interactions known.

[SAFE IF PRESCRIBED] Azelaic Acid 20% topical is generally considered safe to use during pregnancy (FDA Pregnancy Category B). Animal studies have shown low or no adverse effects to the developing baby; however, there are limited human studies. Use only if clearly needed.

[SAFE IF PRESCRIBED] Azelaic Acid 20% topical is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby. Use with caution.

Safety and efficacy in pediatric patients under 12 years of age have not been established. Patients over 12 years: same as adult dose.

No specific dose adjustment needed for elderly patients.

Systemic absorption with topical application is minimal, so no dose adjustment is needed for renal or hepatic impairment.

Over-application may cause skin irritation or allergic reactions. Discontinue use and consult a doctor if symptoms occur.

Store in a cool and dry place, protected from light. Keep out of reach of children.

Azelaic Acid (C₉H₁₆O₄)