Afloderm, 0.05% 20 g ointment

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.

Alclomethasone is thought to induce 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® ointment is intended for the treatment of chronic and subacute dermatoses, especially with dry and scaly lesions, the presence of infiltration or in cases where the occlusive effect of the ointment is necessary.

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 ointment contains:

Active ingredient:

alklometasone dipropionate – 0.5 mg.

Excipients:

soft white paraffin – 799.5 mg;

white beeswax – 60 mg;

propylene glycol monopalmitostearate – 20 mg;

hexylene glycol – 120 mg.

Pregnancy

The use of Afloderm during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. In such cases, the use of the drug should be short-term and limited to a small area of ​​skin.

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

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

Contraindications

Lupus;
skin manifestations of syphilis;
chicken pox;
viral skin infections;
skin post-vaccination reactions;
open wounds;
trophic ulcers;
rosacea;
acne vulgaris;
hypersensitivity to alklometasone or to any of the auxiliary components of the drug.

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