Azelaic acid Vertex (Cream) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

ATC Code

D10AX03 (Azelaic acid)

Active Substance

Azelaic acid (Rec.INN registered by WHO)

Dosage Form

Azelaic acid Vertex

Cream for external use 20%: tubes 10 g, 15 g, 30 g, or 50 g

Dosage Form, Packaging, and Composition

Cream for external use white, homogeneous.

Excipients: propylene glycol, isopropyl myristate, cetearyl alcohol (cetyl alcohol not more than 60%, stearyl alcohol not less than 40%), glyceryl monostearate, glycerol (glycerin), macrogol-20 cetearyl ether, cetyl palmitate, macrogol-6 cetearyl ether, benzoic acid, purified water.

10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of acne

Pharmacotherapeutic Group

Acne treatment agent

Pharmacological Action

Acne treatment agent. It has antimicrobial activity against Propionibacterium acne and Staphylococcus epidermidis.

In addition, it reduces the content of free fatty acids in skin lipids and normalizes impaired keratinization processes in the sebaceous gland follicles.

Pharmacokinetics

After application to the skin, Azelaic acid penetrates into the epidermis and dermis.

Part of the absorbed azelaic acid is excreted by the kidneys unchanged, and part in the form of dicarboxylic acids (C5, C7), formed from azelaic acid as a result of beta-oxidation.

Indications

Acne vulgaris, seborrheic dermatitis, rosacea (including in the presence of papules and pustules), pathological hyperpigmentation (including melasma).

ICD codes

Dosage Regimen

Cleanse and dry affected skin areas thoroughly before each application.

Apply a thin layer of cream and gently massage into the skin twice daily, in the morning and evening.

Use the 20% cream for all indicated conditions, including acne vulgaris, rosacea, and hyperpigmentation.

The duration of therapy is set individually; clinical improvement in acne is typically observed after 4 weeks.

For rosacea, continue application for the full prescribed course to achieve optimal therapeutic effect.

If excessive skin irritation occurs, reduce application frequency to once daily until tolerance develops.

Resume twice-daily application as tolerated. Discontinue use if severe irritation persists.

Avoid contact with eyes, mouth, and other mucous membranes. Wash hands immediately after application.

Adverse Reactions

Local reactions rarely (mainly at the beginning of therapy) – skin irritation, erythema, burning sensation, itching, peeling (disappear on their own during further treatment).

Contraindications

Hypersensitivity to azelaic acid; children under 12 years of age for acne, children under 18 years of age – for rosacea.

Use in Pregnancy and Lactation

Use during pregnancy is possible if indicated.

Given the low systemic bioavailability and low toxicity of azelaic acid, use during lactation (breastfeeding) is possible.

In experimental studies on laboratory animals, no negative effect of azelaic acid on reproductive function was revealed, and no embryotoxic or teratogenic effects were established.

Pediatric Use

Contraindicated for use in children under 12 years of age for acne, in children under 18 years of age – for rosacea.

Special Precautions

Avoid contact with mucous membranes and eyes.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.