Azix-derm, 20% cream 30 g

Azix-derm causes a moderate cytostatic effect (by inhibiting the synthesis of cellular proteins) manifested in the normalization of keratinization processes in the wall of sebaceous gland follicles; has antimicrobial action (first of all against Propionibacterium acnes and Staphylococcus epidermidis) both on the skin surface and in sebaceous glands, as well as anti-inflammatory action (reducing neutrophil granulocytes metabolism and production of free radical oxygen forms – important factors of inflammatory process maintenance).

Long-term use of the drug does not form resistance of microorganisms. Azelaic acid dose-dependently inhibits the growth and viability of abnormal melanocytes.

The therapeutic effect in hyperpigmentation (melasma) is caused by inhibition of DNA synthesis and/or suppression of cellular respiration of abnormal melanocytes. The therapeutic effect of azelaic acid in rosacea is associated with a decrease in the formation of pro-inflammatory reactive oxygen radicals.

Azelaic acid penetrates into the epidermis and dermis after application of Azix-Derm cream. After 1g of azelaic acid (corresponding to 5g of cream) is applied to the skin, about 4% of the dose is absorbed into the systemic bloodstream. Part of the absorbed azelaic acid is excreted unchanged by the kidneys, and part of it is excreted in the form of dicarboxylic acids (C5, C7), which are formed from azelaic acid by beta-oxidation.

Indications

Acne vulgaris, pathological hyperpigmentation, incl. Melasma.

Pharmacological effect

Azix-derm causes a moderate cytostatic effect (due to inhibition of the synthesis of cellular proteins), manifested in the normalization of keratinization processes in the wall of the sebaceous gland follicles; has an antimicrobial effect (primarily against Propionibacterium acnes and Staphylococcus epidermidis) both on the surface of the skin and in the sebaceous glands, as well as an anti-inflammatory effect (reducing the metabolism of neutrophil granulocytes and their production of free radical forms of oxygen – important factors in maintaining the inflammatory process).

With long-term use of the drug, microbial resistance does not develop. Azelaic acid dose-dependently inhibits the growth and viability of abnormal melanocytes.

The therapeutic effect for hyperpigmentation (melasma) is due to inhibition of DNA synthesis and/or suppression of cellular respiration of abnormal melanocytes. The therapeutic effect of azelaic acid in rosacea is associated with a decrease in the formation of pro-inflammatory reactive oxygen radicals.

After applying Azix-Derm cream to the skin, azelaic acid penetrates the epidermis and dermis. After applying 1 g of azelaic acid to the skin (which corresponds to 5 g of cream), about 4% of the dose is absorbed into the systemic circulation. 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.

Special instructions

Avoid contact of the drug with the eyes, as well as the mucous membranes of the nose, lips and mouth. If this happens, rinse them immediately with plenty of water. In cases of severe skin irritation in the first weeks of treatment, Azix-Derm can be applied once a day or the amount of cream applied to the skin can be reduced; Short-term withdrawal of the drug is also possible.

After the symptoms of skin irritation disappear, regular use of the drug at the recommended dose should be resumed.

Dermal melasma is insensitive to treatment with the drug. To carry out differential diagnosis, a Wood’s lamp is used. Azix-Derm can be used in combination with other acne treatment methods.

In this case, it is possible to adjust the dosage regimen of simultaneously used drugs. Azix-Derm does not have any effect on the reaction rate when driving vehicles or operating other mechanisms.

Active ingredient

Azelaic acid

Composition

1 g of cream for external use contains:

active ingredient:

azelaic acid 200 mg.

Excipients:

Benzoic acid 2 mg, Arlaton 983 (glyceryl monostearate) 52.5 mg, Cutana 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. up to 1 year

Pregnancy

During pregnancy and lactation, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child.

Avoid applying cream to the breast area before feeding.

Contraindications

Hypersensitivity to the components of the drug, children under 12 years of age.

Side Effects

From the skin: rarely (mainly at the beginning of therapy): skin irritation, skin hyperemia, erythema, burning sensation, itching, peeling, which disappear on their own during further treatment.

Allergic reactions (for example, rash) may occur.

After applying the cream to the skin of the face, a burning and tingling sensation may occur, which disappears within 15 minutes.

Interaction

No clinically significant interactions have been identified with the use of Azix-Derm.

Storage conditions

At a temperature not exceeding 25 °C (do not freeze)

Shelf life

3 years

Manufacturer

Sun Pharmaceutical Industries Ltd, India