Afloderm, 0.05% cream 40 g

Afloderm – anti-inflammatory topical, glucocorticoid, antipruritic.

Pharmacodynamics

A mild to moderate topical GKS. It has anti-inflammatory, antipruritic and vasoconstrictive effects.

The mechanism of anti-inflammatory action is completely unclear.

Alclomethasone is thought to induce the synthesis of phospholipase A2 inhibitors (lipocortins).

As a result, it reduces the release of arachidonic acid from membrane phospholipids.

This leads to inhibition of the synthesis of prostaglandins and leukotrienes (inflammatory mediators) from arachidonic acid.

Pharmacokinetics

The absorption through the skin depends on a number of factors (including the type of dosage form and the integrity of the skin).

Inflammatory and other skin conditions may increase absorption. In healthy volunteers, 3% of alclomethasone 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 tender and sensitive areas of the body (face, neck, chest and genital area) and when additional hydration of the affected skin is required due to the ingredients of the drug base.

Active ingredient

Composition

1 g of the cream contains:

Active substance:

alclometasone dipropionate – 0.5 mg;

Associates:

propylene glycol – 250 mg;

chlorocresol – 1 mg;

sodium dihydrophosphate dihydrate – 2.995 mg;

phosphoric acid – 0.04 mg;

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

macrogoal cetostearate – 22.5 mg;

macrogoal glyceryl stearate – 30 mg;

paraffin soft white – 210 mg;

sodium hydroxide – q.s.;

Purified water – 410.96 mg.

How to take, the dosage

Externally. Afloderm® cream is evenly and thinly applied to the affected skin 2-3 times a day. In children and during convalescence it is possible to use the drug once a day. In order to prevent relapses in the treatment of chronic diseases the therapy should be continued for some time after the disappearance of all symptoms.

Afloderm® can be used in children from 6 months of age.

Please note that in young children the skin folds and synthetic diapers may have effects similar to those of an occlusive dressing and may increase resorption of the active ingredient of the drug. In addition, more systemic resorption is possible in children because of the skin surface to weight ratio and immaturity of the skin.

It is not recommended to apply under occlusive dressings, where diapers and diapers come into contact with the skin. The maximum duration of treatment in children is 3 weeks. Longer use of the drug should only be carried out under the supervision of a physician.

If there is no effect within 2 weeks, the diagnosis should be clarified.

If the acute period of the disease is passed, if there is a need for the drug to be used on the denser parts of the skin (palms, feet), especially if the skin is very dry, and if the anti-inflammatory effect of the drug needs to be seen deeper in the skin, it is recommended to switch to Afloderm® in ointment form.

In case of widespread dermatoses, in addition to the use of Afloderm® ointment for the treatment of dermatoses in delicate and sensitive skin areas (face, neck, chest, genital area) the use of Afloderm® in cream form is recommended.

Afloderm® cream also has cosmetic benefits: it absorbs easily and does not leave a greasy film.

Special Instructions

Avoid getting the drug in the eyes (because of 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 secondary bacterial or fungal infection, an antibacterial or antifungal agent must be added to Afloderm® therapy.

There are no data on the effect of Afloderm® on the ability to drive or perform work requiring increased speed of physical and mental reactions.

Contraindications

Side effects

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

Skin side effects: with frequency of 1% (for ointment) and 2% (for cream) – itching, burning, erythema; with frequency of 2% (for cream) additionally – dry skin, irritation, papular rash; common for both dosage forms: infrequent – folliculitis, acneiform rash, hypopigmentation, perioral dermatitis, dermatitis, secondary infection, skin atrophy, stricture, sweat.

In case of hypersensitivity reactions or adverse events, the therapy should be discontinued and the patient should see a physician.

Overdose

Symptoms: development of systemic side effects of GCS.

Treatment: symptomatic.

Pregnancy use

The use of Afloderm® cream and ointment in pregnant women is permitted. In these cases, application should be under a physician’s supervision, should be of short duration and limited to small areas of skin. There are no data on teratogenic effect.

The use of Afloderm® cream and ointment in breastfeeding mothers is possible. Precautions must be taken when using the drug in breast feeding mothers; in particular, the drug must not be applied to the mammary gland skin before breast feeding.