Azix-Derm (Cream) Instructions for Use

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

ATC Code

D10AX03 (Azelaic acid)

Active Substance

Azelaic acid (Rec.INN registered by WHO)

Dosage Form

Azix-Derm

Cream for external use 20%: tube 30 g

Dosage Form, Packaging, and Composition

Cream for external use white, opaque, homogeneous.

Excipients: benzoic acid – 2 mg, arlaton 983 (glyceryl monostearate) – 52.5 mg, cutina CBS – 73.5 mg, crodamol CAP – 30 mg, silicone oil 350 CST – 5 mg, propylene glycol – 125 mg, glycerol – 15 mg, purified water – q.s. to 1 g.

30 g – laminated aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Acne and hyperpigmentation treatment drug

Pharmacotherapeutic Group

Remedy for acne

Pharmacological Action

Azelaic acid in the therapy of acne normalizes the disturbed processes of keratinization in the sebaceous gland follicles, reduces the content of free fatty acids in skin lipids. It exhibits antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The anti-inflammatory effect is also due to a reduction in neutrophil metabolism and a decrease in their production of free radical oxygen species. Azelaic acid exerts a dose-dependent and time-dependent inhibitory effect on the growth and viability of abnormal melanocytes. The molecular mechanisms of this effect are not fully established. Available data suggest that the main effect of azelaic acid in the treatment of melasma is associated with the inhibition of DNA synthesis and/or cellular respiration in abnormal melanocytes.

Pharmacokinetics

After application to the skin, Azelaic acid penetrates into the epidermis and dermis; penetration into damaged skin occurs faster than into intact skin. After a single topical application of 5 g of cream, 3.6% of the total dose of azelaic acid enters the systemic circulation.

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

Indications

• Mild to moderate acne, including in the presence of papules and pustules;
• Hyperpigmentation of the melasma type, for example, chloasma.

ICD codes

Dosage Regimen

Topically.

Before applying the cream, the skin should be thoroughly washed with clean water and then dried, or a mild cosmetic cleanser should be used. Do not use occlusive dressings.

After each application of the cream to the skin, hands should be washed.

The cream is applied in a thin layer to the affected areas of the skin 2 times/day (morning and evening), gently rubbing into the skin (2.5 cm of cream is sufficient for the entire surface of the face).

In children from 12 to 18 years old, the drug Azix-Derm is used for the treatment of acne, dose adjustment is not required.

The efficacy and safety of the drug in children younger than 12 years for the treatment of acne have not been established.

The efficacy and safety of the drug in children younger than 18 years for the treatment of melasma have not been established.

It is important that the drug Azix-Derm is used regularly throughout the entire treatment period. The duration of treatment is individual and depends on the severity of the disease. Improvement usually occurs after 4 weeks of treatment. If necessary, for the treatment of acne, the drug Azix-Derm can be used for several months. For the treatment of melasma, the minimum period of use of the drug Azix-Derm is 3 months.

During the treatment of melasma, it is mandatory to use broad-spectrum sunscreen products that protect against ultraviolet (UV) radiation: UVA and UVB, to prevent exacerbation of the disease and/or repigmentation of lightened skin areas under the influence of the sun.

If no improvement occurs within 1 month for acne treatment and 3 months for melasma treatment, or if an exacerbation of the disease occurs, the use of the drug Azix-Derm should be discontinued and a doctor should be consulted.

If skin irritation occurs, the amount of cream applied each time should be reduced or the frequency of cream application should be reduced to 1 time per day. A temporary discontinuation of the drug is possible, followed by resumption after the irritation symptoms disappear at the recommended dose.

The drug should be used only according to the method of application and in the doses indicated in the instructions. If necessary, the patient should consult a doctor before using the drug.

Adverse Reactions

The most frequent adverse effects observed in clinical studies and during post-marketing surveillance were burning, itching, and erythema at the application site.

From the immune system frequency unknown – hypersensitivity reaction (including angioedema, contact dermatitis, eye swelling, facial swelling), exacerbation of bronchial asthma.

From the skin and subcutaneous tissues uncommon – seborrhea, acne, skin depigmentation (discoloration); rare – cheilitis.

General disorders and administration site conditions very common at the application site – burning, itching, erythema (redness); common at the application site – desquamation (epidermal peeling), pain, dryness, skin discoloration, skin irritation; uncommon – paresthesia, dermatitis, discomfort, swelling; rare at the application site – rash, eczema, warm sensation, ulcers; frequency unknown – rash, urticaria.

If any of the side effects mentioned in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Contraindications

• Hypersensitivity to azelaic acid and other components of the drug;
• Children under 12 years of age (acne);
• Children under 18 years of age (hyperpigmentation of the melasma type).

With caution in bronchial asthma.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is possible only after consultation with a doctor.

Adequate and strictly controlled studies on the topical use of azelaic acid in pregnant women have not been conducted. Studies in animals have not revealed adverse effects of azelaic acid on pregnancy, intrauterine fetal development, childbirth, or postnatal development. The potential risk to humans is unknown. During pregnancy, the drug Azix-Derm should be used only if the intended benefit to the mother outweighs the potential risk to the fetus.

It is not precisely known whether Azelaic acid passes into breast milk. Given the low systemic absorption of azelaic acid after topical application, during breastfeeding, the drug Azix-Derm should be used only if the intended benefit to the mother outweighs the potential risk to the child. When breastfeeding, it is necessary to avoid applying the drug to the breast area before feeding; contact of children with the skin, including the skin of the breasts, after application of the drug Azix-Derm should be prevented.

Pediatric Use

Contraindications: children under 12 years of age (acne); children under 18 years of age (hyperpigmentation of the melasma type).

Special Precautions

For external use only.

Avoid getting the cream into the eyes, mouth, and other mucous membranes. If the cream accidentally gets on the mucous membranes, including the eyes and mouth, they should be rinsed with plenty of water. If eye irritation does not subside, a doctor should be consulted.

After each application of Azix-Derm cream, hands should be washed.

Melasma located in the epidermis or simultaneously in the epidermis and dermis responds well to treatment with Azix-Derm.

Melasma located only in the dermis is not sensitive to treatment.

A Wood’s lamp is used for differential diagnosis.

The drug Azix-Derm contains benzoic acid, which may cause skin irritation, eye and mucous membrane irritation, and propylene glycol, which may cause skin irritation.

During post-marketing surveillance, rare reports of exacerbation in patients with bronchial asthma during topical use of azelaic acid have been received.

Read the instructions carefully before starting to use the drug. Keep the instructions, they may be needed again. If you have any questions, consult your doctor. The medicine you are being treated with is intended for you personally, and it should not be passed on to others, as it may harm them even if they have the same symptoms as you.

Effect on ability to drive vehicles and operate machinery

The drug Azix-Derm does not affect the ability to drive vehicles and work with machinery.

Overdose

To date, there is no information on overdose.

Drug Interactions

No clinically significant interaction has been identified with the use of the drug Azix-Derm.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). Do not freeze.

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed without a prescription.

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.