Afloderm, 0.05%, 40 g

Belupo, drugs and cosmetics dd, Croatia

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Product Overview

Composition

1 g of cream contains:

Active substance:

alclomethasone 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 - qs;

purified water - 410.96 mg.

pharmachologic effect

Afloderm - local anti-inflammatory, glucocorticoid, antipruritic.

Pharmacodynamics

GCS for external use from low to moderate activity. It has anti-inflammatory, antipruritic and vasoconstrictor effects.

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 the type of dosage form and the integrity of the skin).

Inflammatory and other skin conditions can 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 if there is a need for additional hydration of the affected skin, which is carried out using the components of the drug base.

Application during pregnancy and lactation

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

It is possible to use the drug Afloderm® cream and ointment 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

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

 

Side effects

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

From the side of 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: infrequently - folliculitis, acneform rash, hypopigmentation, perioral dermatitis, dermatitis, secondary infection, skin atrophy, striae, prickly heat.

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

Interaction

Unknown.

How to take, course of administration and dosage

Outwardly. Afloderm® cream is evenly applied in a thin layer to the affected skin 2-3 times a day. In children and during the follow-up period, it is possible to use the drug once a day. To prevent relapses in the treatment of chronic diseases, therapy should be continued for some time after the disappearance of all symptoms.

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

It should be borne in mind that in young children, skin folds and synthetic diapers can have an effect similar to that of an occlusive dressing, and increase the resorption of the active substance of the drug. In addition, in children, a greater degree of systemic resorption is possible due to the ratio between skin surface and body weight, and also due to insufficient skin maturity.

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

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

With the passage of an acute period of the disease, the need to use the drug on the densest areas of the skin (palms, feet), especially with increased dry skin, as well as if the anti-inflammatory effect of the drug in deeper layers of the skin is necessary, it is advisable to switch to the use of Afloderm® in the form of an ointment ...

In case of common dermatoses, along with the use of Afloderm® ointment, for the treatment of dermatoses localized on delicate and sensitive skin areas (face, neck, chest, genital area), it is advisable to switch to the use of Afloderm® in the form of a cream.

In addition, Afloderm® cream has cosmetic benefits - it is easily absorbed and does not leave an oily sheen.

Overdose

Symptoms:  development of systemic side effects of GCS.

Treatment:  symptomatic.

Special instructions

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

Effects on the ability to drive or perform work that requires an increased speed of physical and mental reactions

There are no data on the effect of Afloderm® on the ability to drive vehicles and mechanisms.

Release form

Cream for external use

Storage conditions

At a temperature not exceeding 30 ° C

Shelf life

3 years

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