Afloderm, 0.05% ointment 40 g

Afloderm – anti-inflammatory local, glucocorticoid, antipruritic.

Pharmacodynamics

GKS for external application of mild to moderate activity. 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 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® ointment is for the treatment of chronic and sub-acute dermatoses, especially in dry and flaky lesions, when infiltration is present or when occlusive action of the ointment is necessary.

Active ingredient

Composition

1 g of the ointment contains:

The active ingredient:

alclometasone dipropionate – 0.5 mg;

Excipients:

Paraffin soft white – 799.5 mg;

White beeswax – 60 mg;

propylene glycol monopalmitostearate – 20 mg;

hexylene glycol – 120 mg.

How to take, the 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 applied evenly in a thin layer to the affected areas of the skin 2-3 times a day. Afloderm should be applied more frequently on thicker skin areas (e.g., elbows, palms and feet) and where the product rubs off easily.

In children and while the underlying symptoms are subsiding, it may be used once daily.

In order to prevent relapses in the treatment of chronic conditions, therapy should be continued for some time after all symptoms have disappeared.

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 side effects, the therapy should be stopped and a physician should be consulted.

Overdose

Symptoms: development of systemic side effects of GCS.

Treatment: symptomatic.

Pregnancy use

The use of Afloderm in pregnancy is possible only when the expected benefit to the mother exceeds the potential risk to the fetus. In such cases, the use of the drug should be of short duration and limited to a small area of the skin.

There are no data on teratogenic effects of the drug.

Afloderm can be used during lactation, but with caution; in particular, the drug should not be applied to the mammary gland skin before breast feeding.