Название документа

Pharmacological properties

Pharmacodynamics. alklometazon — synthetic, not fluorinated, moderately acting gks for topical administration. renders anti-inflammatory, antiallergic, immunodepressive, immunosuppressive and anti-proliferative effect.

Anti-inflammatory activity is connected by

with production, release and activity of factors of intermediaries of inflammation, such as quinine, a histamine, lizosomalny enzymes, prostaglandins, leukotrienes which contribute to the development of inflammatory process.

GKS are prevented by expansion of blood vessels and increase in their porosity, respectively, migration of inflammatory cells to a cell of the damaged fabric decreases. This effect reduces an ekstravazation of blood plasma and developing of hypostasis.

Immunosuppressive effect is shown by

in slowing down of reactions of early excessive sensitivity (III and IV type). The mechanism of activity is shown in decrease in toxic action of a complex antigen — an antibody which settles on walls of blood vessels and leads to developing of allergic contact dermatitis, on the one hand, and to decrease of the activity of lymphokines of target cells and macrophages who together lead to development of reaction of allergic contact dermatitis — on the other hand.

GKS also interfere with access of sensibilized T lymphocytes and macrophages to target cells.

Anti-proliferative effect of an alklometazon is shown by

in reduction of amount of hyperplastic fabrics which are typical for psoriasis.

Pharmacokinetics. At topical administration of an alklometazon on the uninjured, healthy skin of 3% of all amount of medicament it is absorbed in the blood circulatory system. Injuries of skin or use of an occlusive bandage can increase absorption of an alklometazon.

Dipropionas is metabolized by Alklometazon's

first of all in a liver; metabolites are mainly removed with urine and their smaller part — with bile.

Indication

Disease of skin at which topical treatment gks is shown (including atopic, allergic and contact dermatitis, psoriasis, eczema).

Use

Afloderm cream is applied only outwardly.

Cream is put with a thin layer, slightly rubbing, on an affected area 2–3 times a day. It is not necessary to use using occlusive bandages, on big sites for a long time with the affected skin as strengthening of absorption of an alklometazon, except for cases of treatment of patients with heavy and steady (resistant) dermatitis is possible. After weakening of symptoms the therapy needs to be stopped.

Contraindication

Hypersensitivity to an alklometazon or other components of drug. a tuberculosis cutis, skin reactions after vaccination, virus damages of skin (especially herpes simplex), chicken pox (chicken pox), perioral dermatitis, a rozatsea and an acne.

Side effects

Topical administration of an alklometazon in therapeutic doses is well transferred by

and seldom causes side effects. at topical administration, medicament can cause rash, an itching, an erythema or xeroderma, irritation and an acne in 1–2% of patients. very seldom there can be changes the skins similar to an acne, a hyperpegmentation, a folliculitis, atrophic changes of skin, a striya, expansion of superficial vessels (especially on a face), a hypertrichosis, allergic contact dermatitis and consecutive infections of skin. local side reactions occur under an occlusive bandage more often.

System side effects at use of an alklometazon can suppress functions of adrenal glands that, perhaps, is a consequence of prolonged use on big sites of skin.

Special instructions

Afloderm apply cream to treatment at a sharp, wet dermatosis.

If at use of medicament reactions of hypersensitivity (the irritation of skin which is followed by an itching, burning and reddening) are observed, therapy it is necessary to stop immediately.

Prolonged use of medicament on big sites of skin is not recommended to

, especially with use of occlusive bandages; careful observation because of a possibility of manifestation of the increased absorption of an alklometazon and also system manifestations is necessary. Patients who enter into risk group of the system side effects caused alklometazony (children with dysfunction of a liver and the patients demanding long-term treatment) should control periodically functions of a system a hypothalamus — a hypophysis — adrenal glands (the test of free cortisol in urine and blood plasma, the test of AKTG-stimulation). If oppression is established, it is necessary to stop administration of drug, to reduce use frequency.

Afloderm cream cannot be applied to treatment of eyes and around eyes owing to possible developing of glaucoma or a cataract.

to

In cases of fungal or bacterial superinfection of skin needs also additional local prescription of antibiotics or antifungal means.

Use of medicament is not recommended to

in diapers as they can increase system absorption of active agents of medicament as work as occlusive bandages.

Some places on a body, such as groin, armpits, perianal sites where there is natural occlusion, are sensitive to emergence of extensions at treatment alklometazony.

Therefore use on such sites has to be most limited to

.

Ability to influence speed of response during the driving or work with mechanisms. Data on medicament Afloderm influence cream on ability to run vehicles or to work with other mechanisms are absent.

Use during pregnancy and feeding by a breast

Pregnancy. Topical administration of Afloderm cream during pregnancy is allowed only in cases when, according to the doctor, the expected advantage for the pregnant woman prevails over possible risk for a fruit. In such cases the use has to be short-term and be limited to the small site of a body surface.

feeding Period breast. According to the decision of the doctor Afloderm cream can be applied during feeding by a breast, but medicament cannot be applied to skin of mammary glands before feeding.

Children. Use for children is possible only on appointment and under observation of the doctor. As the relation of a surface of skin of a body concerning body weight at children is higher, than at adults, the increased absorption at topical administration is possible that it can lead to system toxic manifestations of oppression of function of adrenal glands, decrease in excretion of growth hormone. Therefore it is necessary to use medicament at children carefully and in minimum short time (up to 2–3 weeks).

to

Are unknown to

Interaction

.

Overdose

in case of drawing an alklometazon on the big damaged sites of skin, during the long period, at use of an occlusive bandage and also at prolonged use at children can arise the increased absorption of medicament and manifestation of system effects: a hyperglycemia, a glucosuria, oppression of a system a hypothalamus — a hypophysis — adrenal glands with growth delay, intracranial hypertensia (which arises only at children) and Cushing's syndrome.

manifestation symptoms, such as fever, myalgia, an arthralgia, weakness are Very seldom possible

that demands system replaceable use of GKS.

Treatment at overdose. In case of overdose, medicament needs to be cancelled. Therapy symptomatic using usual measures for maintenance of normal functioning of an organism.

Storage conditions

to Store

at a temperature not above 30 °C.

Characteristics
Active ingredients Alklometazon
Amount of active ingredient 0.5 mg/g
Applicant Belupo
Code of automatic telephone exchange D07AB10 Alklometazon
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status The branded generic
Origin Chemical
Prescription status According to the prescription
Primary packing tuba
Producer BELUPO, DRUGS AND D.D. COSMETICS.
Quantity in packing 20 g
Release form external use cream
Route of administration External
Sign Import
Storage temperature from 15 °C to 30 °C
Trade name Afloderm

Reviews Afloderm cream 0.5mg/g of a tube of 20 g

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Afloderm cream 0.5mg/g of a tube of 20 g

  • Product Code: 182726
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