Afloderm, 0.05% cream 20 g

Afloderm is an anti-inflammatory topical, glucocorticoid, antipruritic.

Pharmacodynamics

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

The mechanism of anti-inflammatory action is completely unclear. It is believed that alclomethasone 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

Absorption through the skin depends on a number of factors (including type of dosage form and skin integrity). 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 of delicate and sensitive areas of the body (face, neck, chest, 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:

The active ingredient:

alclomethasone dipropionate – 0.5 mg;

Excipients:

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

Interaction

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

Special Instructions

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

Afloderm should not be used on the skin in the eye area (because of possible development of glaucoma and cataracts) and on open wound surfaces.

If the disease is complicated by the development of secondary bacterial or fungal infection, Afloderm therapy must be supplemented with a specific antibacterial or antimycotic agent.

Pediatric use

The drug can be used in young children.

Please note that in young children, skin folds and diapers may have an effect similar to that of an occlusive dressing and may increase the systemic absorption of the active ingredient accordingly. In addition, in children, a greater degree of systemic absorption is possible due to the ratio of skin surface to body weight and due to insufficient maturity of the epidermis. That is why long-term use in young children is possible only under a physician’s supervision.

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

Pregnancy

The use of Afloderm® Cream in pregnant women is permitted. In these cases, application should be under the supervision of a physician, should be of short duration and limited to small areas of skin. There is no data about teratogenic effect.

Breastfeeding

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