Afloderm
Producer: BELUPO, Pharmaceuticals & Cosmetics, d.d. Republic of Croatia
Code of automatic telephone exchange: D07AB10
Release form: Soft dosage forms. Ointment.
General characteristics. Structure:
Active agent: an alklometazona Dipropionas - 0,500 mg;
Excipients: white soft paraffin, white beeswax, propylene glycol монопальмитостеарат, hexyleneglycol.
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).
Афлодерм® ointment is intended for therapy of a chronic and subacute dermatosis, in particular at the dry and shelled defeats, in the presence of infiltration or when occlusal effect of ointment is necessary.
Route of administration and doses:
Only for external use.
Afloderm® ointment is evenly applied 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. 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. At a widespread dermatosis, along with Afloderm® ointment use, for therapy of the dermatosis localized on gentle and sensitive sites of skin (on a face, a neck, a breast, area of genitalias) transition to drug use Afloderm in the form of cream is reasonable. In addition cream Afloderm has cosmetic advantages - is easily absorbed and does not leave a greasy luster.
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, the 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 the drug 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; tuberculosis cutis, skin displays of syphilis, chicken pox, viral infections of skin, skin postvaccinal reactions, open wounds, trophic ulcers, rozatsea, vulgar eels; children's age (up to 6 months).
Use at pregnancy and during breastfeeding
Pregnancy
Drug Afloderm® use ointment 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 ointment 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:
Ointment for external use of 0,05%
On 20 g and 40 g of ointment 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.