Afloderm® [Alclomethasone]

Pharmacological properties

Alclomethasone is a synthetic, non-fluorinated, moderately active corticosteroids for topical application. It has anti-inflammatory, anti-allergic, immunosuppressive, immunosuppressive and antiproliferative effects.

Anti-inflammatory activity is associated with the production, release and activity of factors of inflammatory mediators, such as quinine, histamine, lysosomal enzymes, prostaglandins, leukotrienes, which contribute to the development of the inflammatory process.

GCS prevent the expansion of blood vessels and increase their porosity, respectively, decreases the migration of inflammatory cells to the cell of damaged tissue. This effect reduces the extravasation of blood plasma and the occurrence of edema.

The immunosuppressive effect is manifested in the inhibition of reactions of early excessive sensitivity (type III and IV). The mechanism of activity is manifested in a decrease in the toxic effect of the antigen-antibody complex, which settles on the walls of blood vessels and leads to allergic contact dermatitis, on the one hand, and to a decrease in the activity of target cells and macrophages lymphokines, which together lead to the development of an allergic contact dermatitis reaction, - on the other hand.

GCS also impedes the access of sensitized T-lymphocytes and macrophages to target cells.

The antiproliferative effect of alklomethasone is manifested in a decrease in the number of hyperplastic tissues that are typical of psoriasis.

Pharmacokinetics With topical use of alklomethasone on intact, healthy skin, 3% of the total amount of the drug is absorbed into the circulatory system. Skin lesions or the use of an occlusive dressing may increase the absorption of alklomethasone.

Alclomethasone dipropionate is metabolized primarily in the liver; metabolites are mainly excreted in the urine and a smaller part of them are excreted in the bile.

Indications

Skin diseases in which local treatment for corticosteroids is indicated (including atopic, allergic and contact dermatitis, psoriasis, eczema).

Application

Afloderm cream is used only externally.

The cream is applied in a thin layer, rubbing slightly, on the affected area 2-3 times a day. It should not be used for a long time with the use of occlusive dressings, in large areas with affected skin, since it is possible to increase the absorption of alklomethasone, with the exception of cases of treatment of patients with severe and resistant (resistant) dermatitis. After the symptoms have eased, therapy should be discontinued.

Contraindications

Hypersensitivity to alklomethasone or other components of the drug. skin tuberculosis, skin reactions after vaccination, viral skin lesions (especially herpes simplex), chicken pox (chicken pox), perioral dermatitis, rosacea and acne.

Side effects

Topical use of alklomethasone in therapeutic doses is well tolerated and rarely causes side effects. in 1–2% of patients with topical administration, the drug can cause rash, itching, erythema or dry skin, irritation and acne. very rarely skin changes like acne, hyperpigmentation, folliculitis, atrophic changes in the skin, striae, expansion of the superficial vessels (especially on the face), hypertrichosis, allergic contact dermatitis and secondary skin infections can occur. local adverse reactions often occur under an occlusive dressing.

Systemic side effects with the use of alklomethasone can suppress adrenal function, which may be the result of prolonged use in large areas of the skin.

special instructions

Afloderm cream is used to treat acute, wet dermatoses.

If during the use of the drug hypersensitivity reactions are observed (skin irritation, accompanied by itching, burning and redness), therapy should be stopped immediately.

Long-term use of the drug in large areas of the skin is not recommended, especially with the use of occlusive dressings; careful monitoring is necessary because of the possibility of manifestation of increased absorption of alklomethasone, as well as systemic manifestations. Patients who are at risk for systemic side effects caused by alklomethasone (children with liver dysfunction and patients requiring long-term treatment) should periodically monitor the functions of the hypothalamus-pituitary-adrenal system (test of free cortisol in urine and blood plasma, ACTH stimulation test ) If inhibition is established, it is necessary to stop taking the drug, reduce the frequency of use.

Afloderm cream cannot be used to treat the eyes and around the eyes due to the possible occurrence of glaucoma or cataracts.

In cases of fungal or bacterial superinfection of the skin, additional local administration of antibiotics or antifungal agents is also necessary.

The use of the drug is not recommended in diapers (diapers), since they can increase the systemic absorption of the active substances of the drug, since they act as occlusive dressings.

Some places on the body, such as the groin, armpits, perianal areas where there is natural occlusion, are sensitive to the appearance of stretch marks during treatment with alklomethasone.

Therefore, the application in such areas should be as limited as possible.

The ability to influence the reaction rate when driving a vehicle or working with machinery. There are no data on the effect of Afloderm Cream on the ability to drive vehicles or work with other mechanisms.

Use during pregnancy and lactation

Pregnancy. Topical use of Afloderm cream during pregnancy is allowed only in cases where, according to the doctor, the expected benefit for the pregnant woman prevails over the possible risk to the fetus. In such cases, the application should be short-term and limited to a small area of ​​the body surface.

The period of breastfeeding. By the decision of the doctor Afloderm cream can be used during breastfeeding, but the drug can not be applied to the skin of the mammary glands before feeding.

Children. Use in children is possible only as directed and under the supervision of a doctor. Since the ratio of the surface of the skin of the body relative to body weight in children is higher than in adults, increased absorption with topical application is possible, which can lead to systemic toxic manifestations of inhibition of adrenal function, decreased growth hormone excretion. Therefore, it is necessary to use the drug in children with great care and in the shortest possible time (up to 2-3 weeks).

Interactions

Unknown.

Overdose

In the case of applying alklomethasone to large damaged areas of the skin for a long period, with the use of an occlusive dressing, as well as with prolonged use, children may experience increased absorption of the drug and the manifestation of systemic effects: hyperglycemia, glucosuria, inhibition of the hypothalamus-pituitary-adrenal gland system with a slowdown growth, intracranial hypertension (which occurs only in children) and cushing syndrome.

Very rarely, symptoms of manifestation are possible, such as fever, myalgia, arthralgia, weakness, which requires systemic replacement use of GCS.

Overdose treatment. In case of an overdose, the drug must be discontinued. Therapy is symptomatic with the use of conventional measures to maintain the normal functioning of the body.

Storage conditions

Store at a temperature not exceeding 30 ° C.