Aziks-Derm - instructions for use, doses, side effects, contraindications

Excipients: benzoic acid 2 mg, arlaton 983 (glyceryl monostearate) 52.5 mg, kutane 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 g.

Description:White, opaque, homogeneous cream.

Pharmacotherapeutic group:Acne rash remedy

ATX: & nbsp

D.10.A.X.03 Azelanic acid

Pharmacodynamics:

Causes a moderate cytotoxic effect (due to inhibition of the synthesis of cellular proteins), manifested in the normalization of keratinization in the wall of follicles of the sebaceous glands; antimicrobial effect (especially in relation to Propionibacterium acnes and Staphylococcus epidermidis) both on the surface of the skin and in the sebaceous glands, as well as anti-inflammatory action (reducing the metabolism of neutrophilic granulocytes and the production of free-radical oxygen forms by them - important factors in maintaining the inflammatory process).

With prolonged use of the drug, microorganisms are not resistant. Azelaic. acid dose-dependent inhibits, growth and viability of abnormal melanocytes. The therapeutic effect of 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.

Pharmacokinetics:

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

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

Indications:

- Acne vulgaris (acne vulgaris).

- Pathological hyperpigmentation, incl. melasma.

Contraindications:

- Hypersensitivity to the components of the drug.

- Children under 12 years.

Pregnancy and lactation:During pregnancy and lactation, the drug is used only in If the intended benefit to the mother exceeds the potential risk to the fetus and the baby. It is necessary to avoid applying cream on the area of the mammary glands before feeding.

Dosing and Administration:

Outwardly.

The maximum duration of therapy depends on the individual pattern of the disease and the severity of the symptoms and is determined by the attending physician.

Adults and children over 12 years of age are given a uniformly thin layer of the cream 2 times a day (morning and evening) on the previously cleaned (with soft cleansers and water) and dried skin and, if necessary, the neck and upper chest, affected by acne.

For the entire surface of the face, about 2.5 cm of the cream column from the tube is sufficient. A drug should be used regularly throughout the course of treatment, the duration of which depends on the severity of the disease.

The minimum duration of treatment for melasma is 3 months. During the treatment of melasma, sunscreen should be used (UV In and UV A) in order to prevent the exacerbation of the disease and / or re-pigmentation of the skin under exposure to the sun.

In patients with acne vulgaris (acne vulgaris) marked improvement usually observed after 4 of the week. To obtain the best results, the drug should be continued for several months.

Side effects:

From the skin

Rarely (mainly at the beginning of therapy): skin irritation, skin hyperemia; erythema, a burning sensation, itching, peeling, which pass on their own during further treatment.

There may be allergic reactions (for example, rashes).

After applying the cream on the skin of the face, a burning and tingling sensation can occur which lasts for 15 minutes.

Overdose:

Currently, cases of an overdose of Aziks-Derm cream are not described.

Interaction:

The interaction of the drug Azix-Derm with other drugs has not been known to date.

Special instructions:

Avoid contact with the eyes, as well as the mucous membranes of the nose, lips and mouth. If this happens, immediately wash them with plenty of water.

In cases of severe skin irritation in the first weeks of treatment, Aziks-Derm can be applied 1 time / day or reduce the amount of cream applied to the skin; also a short-term cancellation of the drug is possible.After the disappearance of symptoms of skin irritation, you should resume regular use of the drug at the recommended dose.

Dermal melasma is insensitive to drug treatment: for differential diagnostics use a Wood lamp.

Aziks-Derm can be used in combination with other methods of therapy for acne. When It is possible to correct the dosage regimen of concurrently used drugs.

Effect on the ability to drive transp. cf. and fur:Aziks-Derm has no influence on the reaction rate when driving vehicles or working with other mechanisms.

Form release / dosage:Cream for external use 20%.

Packaging:30 g of cream, in a tube of aluminum foil with a laminated coating with a screw cap; 1 tube with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001768

Date of registration:02.07.2012 / 04.08.2016

Expiration Date:02.07.2017

The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India

Manufacturer: & nbsp

Sun Pharmaceutical Industries, Ltd. India

Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India

Information update date: & nbsp21.06.2017

Illustrated instructions

Instructions

Aziks Derm (Azix-Derm)