Afloderm
Producer: BELUPO, Pharmaceuticals & Cosmetics, d.d. Republic of Croatia
Code of automatic telephone exchange: D07AB10
Release form: Soft dosage forms. Cream.
General characteristics. Structure:
Active agent: an alklometazona Dipropionas - 0,500 mg;
Excipients: propylene glycol, chlorocresol, dihydrophosphate sodium a dihydrate, phosphoric acid, cetostearyl alcohol [cetyl alcohol of 60%, stearyl alcohol of 40%], a macrogoal цетостеарат, a macrogoal glyceryl stearate, white soft paraffin, sodium hydroxide, the water purified.
Pharmacological properties:
Glucocorticosteroid for external use from weak to more moderately degree of activity. Has antiinflammatory, antipruritic and vasoconstrictive effect. The mechanism of antiinflammatory action is completely not clear. It is considered that алклометазон induces synthesis of inhibitors of a phospholipase of A2 (lipokortin). Therefore release of arachidonic acid from phospholipids of membranes decreases. It leads to oppression of synthesis of prostaglandins and leukotrienes (inflammation mediators) from arachidonic acid.
Pharmacokinetics. Absorption through skin depends on a number of factors (including a type of a dosage form and integrity of integuments). Inflammatory and other diseases of skin can increase absorption. At healthy volunteers during 8 h 3% of an alklometazon are absorbed.
Indications to use:
The dermatosis and inflammatory diseases of skin reacting to topical therapy by glucocorticosteroid drugs (including: eczema, atopic dermatitis, allergic and contact dermatitis, including phytodermatitis, psoriasis, photodermatitis and sunblisters, allergic reactions to stings of insects).
Afloderm cream is applied to therapy of acute and subacute stages of the inflammatory diseases of skin including which are followed by exudation.
Афлодерм® cream is recommended for therapy of inflammatory diseases of skin on gentle and sensitive body parts (a face, a neck, a breast, area of genitalias) and at the need for additional hydration of the struck integuments which is carried out at the expense of drug basis components.
Route of administration and doses:
Only for external use.
Afloderm® cream is evenly applied with a thin layer on affected areas of skin by 2-3 times a day. At children and in the period of an aftercare it is possible to use drug once a day. For prevention of a recurrence at treatment of chronic diseases therapy it is necessary to continue still some time after disappearance of all symptoms.
The drug Afloderm® can be used at children from sixth month of life. It is necessary to consider that at small children skin folds and synthetic diapers can have the effect similar to action of an occlusive bandage and raise a resorption of active ingredient of drug. Besides, at children big degree of a system resorption because of a ratio between a surface of integuments and body weight, and also in connection with an insufficient maturity of skin is possible. It is not recommended to put under occlusive bandages, in places of contact of diapers and diapers with skin. The maximum duration of treatment at children - 3 weeks. More prolonged use of drug has to be carried out only under control of the doctor.
In the absence of effect within 2 weeks it is necessary to specify the diagnosis. When passing the acute period of a disease, in need of use of drug on the most dense sites of skin (a palm, foot), especially at the raised xeroderma, and also if necessary manifestation of antiinflammatory effect of drug in deeper layers of skin, transition to use of the drug Afloderm® in the form of ointment is reasonable.
Features of use:
It is necessary to avoid hit of drug in eyes (because of possible development of glaucoma and a cataract), and also on open wound surfaces. If the course of a disease is complicated by development of a consecutive bacterial or fungal infection, drug Afloderm it is necessary to add antibacterial or antifungal agent to therapy.
Influence on ability of control of vehicles and mechanisms
Data on impact of drug of Afloderm on ability to manage vehicles and mechanisms are absent.
Side effects:
Usually drug is well transferred. By-effects at external use of an alklometazon develop seldom and have reversible character.
From integuments: with a frequency of 2% - an itch and burning, an erythema, a xeroderma, irritation, papular rash; infrequently - a folliculitis, akneiformny rash, hypopigmentation, perioral dermatitis, dermatitis, consecutive infection, an atrophy of skin, a striya, a heat rash.
In case of development of reactions of hypersensitivity or by-effects therapy it is necessary to cancel and see a doctor!
Interaction with other medicines:
Interactions with other medicines are unknown.
Contraindications:
Hypersensitivity to an alklometazon or to any of auxiliary components of drug; a tuberculosis cutis, skin displays of syphilis, chicken pox, viral infections of skin, skin postvaccinal reactions, open wounds, trophic ulcers, children's age (up to 6 months).
Use at pregnancy and during breastfeeding
Pregnancy
Drug Afloderm® use cream at pregnant women is allowed. In these cases use has to be carried out under control of the doctor, to be short and to be limited to small sites of skin. Data on teratogenic effect are absent.
Breastfeeding
Drug Afloderm® use cream at nursing mothers is possible. Observance of precautionary measures when using drug at nursing mothers is necessary, in particular, drug cannot be applied on skin of a mammary gland before feeding.
Overdose:
Symptoms: development of system side effects of GKS.
Treatment: symptomatic.
Storage conditions:
At a temperature not above 30 °C.
To store in the place, unavailable to children!
Issue conditions:
Without recipe
Packaging:
Cream for external use of 0,05%
On 20 and 40 g of cream in aluminum tubas. The opening of a tuba is protected by a membrane. The tuba is closed a polyethylene cap with the perforator for a membrane. Each tuba is placed in a cardboard pack together with the application instruction.