Afloderm, 0.05% ointment, 20g

Composition

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of 1 g of ointment contains:

Active ingredient:  

alklomethasone dipropionate – 0.5 mg.

Auxiliary substances:

soft white paraffin — 799.5 mg;

white beeswax-60 mg;

propylene glycol monopalmitostearate-20 mg;

hexylene glycol-120 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 ® ointment is intended for the treatment of chronic and subacute dermatoses, especially with dry and flaky lesions, the presence of infiltration or in cases where the occlusive effect of the ointment is necessary.

Use during pregnancy and lactation

The use of Afloderm during pregnancy is possible only if the intended benefit to the mother exceeds 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.

There are no data on the teratogenic effect of the drug.

It is possible to use Afloderm during lactation, but with the observance of precautions, in particular, the drug should not be applied to the skin of the breast before feeding.

Contraindications

• Tuberculosis of the skin;
• skin manifestations of syphilis;
• chickenpox;
• viral infections of the skin;
• skin post-vaccination reactions;
• open wounds;
• trophic ulcers;
• rosacea;
• acne vulgaris;
• hypersensitivity to Alclometasone or to any of the auxiliary components of the drug.

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

The ointment is recommended for the treatment of subacute and chronic dermatoses, including dry, lichenized and flaky lesions, or in cases where the occlusive effect of the ointment is necessary.

The ointment is evenly applied in a thin layer on the affected areas of the skin 2-3 times a day. Afloderm should be applied more frequently to areas with denser skin (for example, elbows, palms and feet), as well as places from which the drug is easily erased.

In children and during the period of subsiding of the main symptoms, the drug can be used 1 time / day.

To prevent relapses in the treatment of chronic diseases, therapy should be continued for some time after all symptoms disappear.

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

Ointment for external use

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Alklomethasone

Dosage form

ointment

Description

Children older than 6 months, Pregnant women as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Children as prescribed by a doctor

Indications

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