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, incl. accompanied by exudation.

Afloderm® cream is recommended for the treatment of inflammatory skin diseases on delicate and sensitive areas of the body (face, neck, chest, genital area) and when there is a need for additional hydration of the affected skin, which is provided by the components of the drug base.

Pharmacological effect

Afloderm is a local anti-inflammatory, glucocorticoid, antipruritic.

Pharmacodynamics

GCS for external use with weak to moderate degree of activity. It has anti-inflammatory, antipruritic and vasoconstrictive effects.

The mechanism of anti-inflammatory action is completely unclear. It is believed that alklometasone 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 the type of dosage form and the integrity of the skin). Inflammatory and other skin conditions may increase absorption. In healthy volunteers, 3% alklometasone is absorbed within 8 hours.

Special instructions

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

Afloderm should not be applied to the skin in the eye area (due to the possible development of glaucoma and cataracts), as well as to 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 must be added to therapy with Afloderm.

Use in pediatrics

The drug can be used in young children.

It should be borne in mind that in young children, skin folds and diapers may have an effect similar to that of an occlusive dressing and, accordingly, increase the systemic absorption of the active substance. In addition, in children, a greater degree of systemic absorption is possible due to the relationship between the surface of the skin and body weight, as well as due to the insufficient maturity of the epidermis. Therefore, long-term use in young children is possible only under the supervision of a physician.

Active ingredient

Alclomethasone

Composition

1 g of cream contains:

Active ingredient:

alklometasone dipropionate – 0.5 mg;

Excipients:

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 cetostearate – 22.5 mg;

macrogol glyceryl stearate – 30 mg;

soft white paraffin – 210 mg;

sodium hydroxide – q.s.;

purified water – 410.96 mg.

Pregnancy

Pregnancy

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

Breastfeeding

It is possible to use the drug Afloderm® cream 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 mammary gland before feeding.

Contraindications

Hypersensitivity to alklometasone 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, childhood (up to 6 months).

Side Effects

The drug is usually well tolerated. Side effects with external use of aclomethasone develop rarely and are reversible.

From 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 to both dosage forms: uncommon – folliculitis, acneiform rash, hypopigmentation, perioral dermatitis, dermatitis, secondary infection, skin atrophy, stretch marks, miliaria.

If hypersensitivity reactions or side effects develop, therapy should be discontinued and consult a doctor.

Interaction

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

Overdose

Symptoms: development of systemic side effects of GCS.

Treatment: symptomatic.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia