Afloderm, cream 0.05%, 20g

Composition

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of 1 g of cream contains:

Active ingredient:  

alklomethasone dipropionate-0.5 mg;

Auxiliary substances:

propylene glycol — 250 mg;

chlorocresol — 1 mg;

sodium dihydrogen phosphate dihydrate — 2,995 mg;

phosphoric acid — 0.04 mg;

cetostearyl alcohol (cetyl alcohol — 60%, stearyl alcohol — 40%) — 72 mg;

macrogol cetostearyl — 22.5 mg;

macrogol glycerilstearates — 30 mg;

paraffin soft white — 210 mg;

sodium hydroxide q. s. ;

purified water — 410,96 mg.

Pharmacological action

of Afloderm – local anti-inflammatory, glucocorticoid, antipruritic.

Pharmacodynamics

of corticosteroids for external use from a weak to moderate degree of activity. It has anti-inflammatory, antipruritic and vasoconstrictor effects.

The mechanism of anti-inflammatory action is completely unclear. It is believed that Alclometasone induces the synthesis of phospholipase A2 inhibitors (lipocortins). As a result, the release of arachidonic acid from membrane phospholipids is reduced. This leads to inhibition of the synthesis of prostaglandins and leukotrienes (inflammatory mediators) from arachidonic acid.

Pharmacokinetics

Skin absorption depends on a number of factors (including the type of dosage form and the integrity of the skin). Inflammatory and other skin conditions can increase absorption. In healthy volunteers,3% of Alclometasone is absorbed within 8 hours.

Indications

Afloderm ® cream is used for the treatment of acute and subacute stages of inflammatory skin diseases, including those accompanied by exudation.

Afloderm ® cream is recommended for the treatment of inflammatory skin diseases in delicate and sensitive areas of the body (face, neck, chest, genital area) and when additional hydration of the affected skin is required, which is carried out at the expense of the components of the base of the drug.

Use during pregnancy and lactation

Pregnancy

The use of Afloderm ® cream in pregnant women is allowed. In these cases, the application should be carried out under the supervision of a doctor, be short-lived and limited to small areas of the skin. There are no data on the teratogenic effect.

Breast-feeding

Afloderm cream may be used in nursing mothers. It is necessary to observe precautions when using the drug in nursing mothers, in particular, the drug should not be applied to the skin of the breast before feeding.

Contraindications

Hypersensitivity to Alclometasone or to any of the auxiliary components of the drug; skin tuberculosis, skin manifestations of syphilis, chickenpox, viral skin infections, skin post-vaccination reactions, open wounds, trophic ulcers, children (up to 6 months).

Side effects

The drug is usually well tolerated. Side effects with external use of Alclometasone are rare and reversible.

From the side of the skin:  with a frequency of 1% (for ointment) and 2% — for cream) – itching, burning, erythema; with a frequency of 2% (for cream) additionally-dry skin, irritation, papular rash; common for both dosage forms: infrequently-folliculitis, acne rash, hypopigmentation, perioral dermatitis, dermatitis, secondary infection, skin atrophy, striae, sweating.

In case of hypersensitivity reactions or side effects, therapy should be discontinued and a doctor should be consulted.

Interaction

No clinically significant interaction of Afloderm with other medicinal products has been established.

How to take, course of use and dosage

For external use only. Afloderm cream is evenly applied in a thin layer on the affected skin 2-3 times a day. In children and during the period of post-treatment, it is possible to use the drug once a day. To prevent relapses in the treatment of chronic diseases, therapy should be continued for some time after all symptoms disappear. Afloderm® can be used in children from the sixth month of life. It should be taken into account that in young children, skin folds and synthetic diapers can have an effect similar to that of an occlusive dressing, and increase the resorption of the Active ingredient of the drug. In addition, children may have a high degree of systemic resorption due to the ratio between the surface of the skin and body weight, as well as due to insufficient skin maturity. It is not recommended to apply under occlusal bandages, in places where diapers and diapers come into contact with the skin. The maximum duration of treatment in children is 3 weeks. Longer – term use of the drug should be carried out only under the supervision of a doctor. If there is no effect within 2 weeks, the diagnosis should be clarified. During the acute period of the disease, if it is necessary to use the drug on the densest areas of the skin (palms, feet), especially with increased dryness of the skin, as well as if the anti-inflammatory effect of the drug is necessary in deeper layers of the skin, it is advisable to switch to the use of Afloderm® in the form of ointment.

Overdose

Symptoms: development of systemic side effects of corticosteroids.

Treatment: symptomatic.

Special instructions

If hypersensitivity reactions (itching, burning and hyperemia) develop during the first application of Afloderm, the drug should be discontinued.

Afloderm should not be applied to the skin around the eyes (due to the possible development of glaucoma and cataracts), as well as on open wound surfaces.

If the course of the disease is complicated by the development of a secondary bacterial or fungal infection, a specific antibacterial or antimycotic agent should be added to Afloderm therapy.

Use in pediatrics

The drug can be used in young children.

It should be taken into account that in young children, skin folds and diapers can have an effect similar to that of an occlusive dressing, and, accordingly, increase the systemic absorption of the Active ingredient. In addition, children may have a high degree of systemic absorption due to the ratio between the surface of the skin and body weight, as well as due to insufficient maturity of the epidermis. Therefore, long-term use in young children is possible only under the supervision of a doctor.

Form of production

Cream for external use

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Alklomethasone

Dosage form

cream

Description

Children prescribed by a doctor, Children over 6 months of age, Nursing mothers prescribed by a doctor, Pregnant women prescribed by a doctor

Indications

Psoriasis, Burns, Allergies, Insect Bites, Eczema, Dermatitis