Afloderm cream 0.05% 20g

Mechanism of action

GKS moderate activity for external use. It has anti-inflammatory, antipruritic, vasoconstrictor and anti-proliferative effect. Reduces the formation, release and activity of inflammatory mediators (kinin, histamine, lysosomal enzymes, prostaglandins and leukotrienes), reduces vasodilation and increased vascular permeability, inhibits cell migration to the site of inflammation, which prevents the occurrence of edema.
Inhibits III and IV type of hypersensitivity reactions), blocking the toxic effect of the antigen-antibody complexes (which concentrate on the walls of blood vessels, which leads to the development of allergic skin vasculitis), on the one hand, and inhibiting the action of lymphokines, target cells and macrophages ( which in the complex are responsible for the reaction of allergic contact dermatitis), on the other hand. The drug also prevents access of sensitized T-lymphocytes and macrophages to target cells.
The antiproliferative effect of alclomethasone is manifested in the reduction of tissue area with hyperplasia characteristic of psoriasis.
Afloderm does not have an irritating or anesthetic effect, does not cause photosensitization, does not affect the immune system (according to experimental studies on laboratory animals).

Suction
When applied to healthy, intact skin, alklomethasone is slightly systemically absorbed (3%). Violation of the integrity of the skin and the use of an occlusive dressing can increase absorption.
Metabolism and excretion
Alclomethasone dipropionate is biotransformed mainly in the liver. Metabolites are excreted mainly from the urine, and to a lesser extent, from the bile.

Indications and usage

Dermatoses sensitive to the treatment of GCS for external use (including atopic dermatitis, contact dermatitis, psoriasis) in the following cases:
- in case of localization of dermatoses in sensitive areas (face, skin folds);
- chronic dermatosis in patients with sensitive skin (children older than 6 months and elderly patients);
-the need to use the drug on large areas of the skin (especially in children);
-the continuation of therapy initiated by other corticosteroids.
The ointment is recommended for use in chronic dermatosis and dry, squamous hyperkeratosis changes; cream - for acute wet dermatosis.

The amount of cream or ointment needed to cover the affected skin area is applied with a thin layer 2-3 times a day and lightly rubbed. After achieving remission of the disease, the use of the drug should be discontinued.
The skin areas on which the drug is applied should not be closed due to the possible enhancement of the systemic absorption of alklomethasone under the occlusive dressing, unless it is due to the clinical situation.

Adverse reactions

Local reactions: itching, burning, redness or dry skin, irritation, papular rash (1-2%); very rarely - acne, hypopigmentation, prickly heat, folliculitis, striae, skin atrophy, hypertrichosis, allergic contact dermatitis, secondary infection. The development of local adverse reactions is more likely when using an occlusive dressing.
In rare cases, with prolonged use of the drug in large areas of the skin may develop systemic side effects.
On the part of the endocrine system: Cushing's syndrome, suppression of the hypothalamic-pituitary-adrenal system, hyperglycemia, glycosuria.
Cardiovascular: increase in blood pressure.
Side effects when using the drug rarely develop and are reversible.

Contraindications

-lupus;
Perioral dermatitis
Rosacea;
- skin reactions at the vaccination site;
-children up to 6 months;
- increased sensitivity to alklomethasone and other components of the drug.

Pregnancy and breastfeeding

Data on the teratogenic effects of corticosteroids for external use during pregnancy in humans are absent.
The use of Afloderm during pregnancy is possible only when the intended benefit to the mother outweighs the potential risk to the fetus. In such cases, the use of the drug should be short and limited to a small area of ​​the skin.
During lactation, the use of Afloderm is possible only under strict indications, but the drug should not be applied to the skin of the breast before feeding.
AT experimental studies no effect of the drug on fertility and reproductive system, as well as fetal, intrauterine and postnatal development.

Cautions

If at the first use of Afloderm hypersensitivity reactions develop (itching, burning and redness), the drug should be discontinued.
Do not recommend long-term use of the drug, application to the vast surface of the affected skin, especially with the use of occlusive dressings, as this can lead to the development of systemic side effects (Cushing's syndrome, suppression of the function of the hypothalamic-pituitary-adrenal system, hyperglycemia, glycosuria, increased blood pressure). These side effects are usually reversible and disappear after discontinuation of the drug. Patients who have an increased risk of side effects during the period of use of the drug requires regular monitoring of the function of the hypothalamic-pituitary-adrenal system. When symptoms of suppression of its function appear, it is necessary to stop using the drug or increase the intervals between its application. In rare cases, symptoms of withdrawal may be noted (fever, myalgia, arthralgia, weakness), which requires GCS replacement therapy for systemic use.
It should be borne in mind that in patients with impaired liver function, suppression of the function of the adrenal cortex is more common.
Afloderm should not be used in the eye area, since in this case glaucoma and cataracts may develop.
In the case of the development of a secondary bacterial or fungal infection during drug therapy, the additional use of antibacterial or antifungal drugs is necessary.
Some areas of the skin (folds and perianal area), where there is a natural occlusion, are more susceptible to the formation of striae, therefore the use of Afloderm in these areas should be as limited as possible.
Use in pediatrics
It should be borne in mind that children are more often observed suppression of the function of the adrenal cortex.
In children, skin folds and diapers can have an effect similar to that of an occlusive dressing, which leads to an increase in systemic absorption of alklomethasone. In addition, children have a large skin area in relation to body weight compared with adults, and the epidermis is underdeveloped, which can also increase the systemic absorption of alklomethasone.
The results of experimental studies
Studies conducted on laboratory animals showed that the use of the drug orally and intraperitoneally in doses 3000 times higher than the doses recommended for external use in humans did not lead to significant toxic effects.
In in vivo and in vitro studies, the drug does not exhibit mutagenic properties.
Data on the carcinogenicity of the drug are not available.
Influence on ability to drive motor transport and control mechanisms
There are no data on the negative impact of Afloderm on the ability to drive vehicles and machinery.

Overdosage

Symptoms: when using the drug on the extensive surfaces of the affected skin with increased absorption of alklomethasone using an occlusive dressing, as well as with prolonged use in children, the systemic side effects of alklomethasone may be enhanced (hyperglycemia, glycosuria, suppression of the hypothalamic-pituitary-adrenal system, growth retardation in children, Cushing's syndrome, increased blood pressure). In very rare cases, the development of withdrawal syndrome (fever, myalgia, arthralgia, weakness) is possible.
Treatment: the drug should be withdrawn. Symptomatic therapy is performed. With the development of withdrawal syndrome, GCS replacement therapy is performed for systemic use.

There is no established clinically significant drug interaction Afloderm with other drugs.

The drug should be stored at a temperature not higher than 30°C out of the reach of children. Shelf life ointment - 3 years. The shelf life of the cream is 2 years.
Pharmacy sales terms
The drug is available on prescription.