Afloderm® (Afloderm®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAlclomethasoneAlclomethasone
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  • Afloderm®
    ointment externally 
    Beluga, medicines and cosmetics.     Croatia
  • Afloderm®
    cream externally 
    Beluga, medicines and cosmetics.     Croatia
    • Dosage form: & nbspcream for external use
    Composition:

    1 g of cream contains:

    active substance: alclomethasone dipropionate 0.500 mg;

    Excipients: propylene glycol 250.00 mg, chlorocresol 1.00 mg, sodium dihydrogen phosphate dihydrate 2.995 mg, phosphoric acid 0.040 mg, cetostearyl alcohol [cetyl alcohol 60%, stearic alcohol 40%] 72.00 mg, macrogol cetostearate 22 , 50 mg, macrogol glyceryl stearate - 30,00 mg, paraffin soft white - 210,00 mg, sodium hydroxide - q.s., purified water - 410.960 mg.

    Description:

    A homogeneous cream of white color.

    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    D.07.A.B   Corticosteroids are moderately active (group II)

    D.07.A.B.10   Alclomethasone

    Pharmacodynamics:

    Glucocorticosteroid for external use from mild to moderate activity. Has anti-inflammatory, antipruritic and vasoconstrictive effect. The mechanism of anti-inflammatory action is completely unclear. It is believed that alclomethasone induces the synthesis of inhibitors of phospholipase A2 (lipocortins). As a result, the release of arachidonic acid from phospholipid membranes 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 form of the dosage form and the integrity of the skin). Inflammatory and other skin diseases can increase absorption. In healthy volunteers, within 3 hours, 3% of the alklomethasone is absorbed.

    Indications:

    Dermatoses and inflammatory skin diseases that react to topical therapy with glucocorticosteroid drugs (including eczema, atopic dermatitis, allergic and contact dermatitis, including phytodermatitis, psoriasis, photodermatitis and sunburn, allergic reactions to insect bites).

    Afloderm® cream is used for the treatment of acute and subacute stages of inflammatory skin diseases, including those accompanied by exudation.

    Afloderm® cream is recommended for the treatment of inflammatory skin diseases in delicate and sensitive areas of the body (face, neck, chest, genital area) and with the need for additional hydration of the affected skin that is carried out by the components of the drug base.

    Contraindications:

    Hypersensitivity to alclomethasone or to any of the auxiliary components of the drug; skin tuberculosis, cutaneous manifestations of syphilis, chickenpox, viral skin infections, skin post-vaccination reactions, open wounds, trophic ulcers, children's age (up to 6 months).

    Pregnancy and lactation:

    Pregnancy

    The use of the drug Afloderm® cream in pregnant women is allowed. In these cases, the application should be under the supervision of a doctor, be short and limited to small areas of the skin. Data on the teratogenic effect are absent.

    Breast-feeding

    It is possible to use the drug Afloderm® cream 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 breast before feeding.

    Dosing and Administration:

    For external use only.

    Cream Afloderm® evenly applied a thin layer on the affected skin 2-3 times a day. At children and in the period of aftercare it is possible to use the drug once a day. For the prevention of relapse in the treatment of chronic diseases, therapy should continue for some time after the disappearance of allsymptoms.

    The drug Afloderm® can be used in children from the sixth month of life. It should be borne in mind that in young children, skin folds and synthetic diapers can have an effect similar to the effect of an occlusive dressing and increase the resorption of the active substance of the drug. In addition, children can have a greater degree of systemic resorption due to the relationship between skin surface and body weight, and also due to insufficient maturation of the skin. It is not recommended to apply under occlusive dressings, in places of contact of diapers and diapers with a skin. The maximum duration of treatment in children is 3 weeks. Longer use of the drug should be done only under the supervision of a doctor.

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

    During the passage of an acute period of the disease, if it is necessary to use the drug on the densest areas of the skin (palm, foot), especially with increased dryness of the skin, and if necessary, the anti-inflammatory effect of the drug in deeper layers of the skin, it is advisable to switch to the use of the drug Afloderm® in the form ointments.

    Side effects:

    Usually the drug is well tolerated. Side effects with external application of alclometasone develop rarely and are reversible.

    From the skin: with a frequency of 2% - itching and burning, erythema, dry skin, irritation, papular rash; infrequently - folliculitis, acneiform rash, hypopigmentation, perioral dermatitis, dermatitis, secondary infection, skin atrophy, striae, sweating.

    In case of development of hypersensitivity reactions or side effects, therapy should be canceled and consult a doctor!

    Overdose:

    Symptoms: development of systemic side effects of GCS.

    Treatment: symptomatic.

    Interaction:

    Interactions with other drugs are unknown.

    Special instructions:

    Avoid contact with the eye (due to the possible development of glaucoma and cataracts), as well as 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 the drug Afloderm®.

    Effect on the ability to drive transp. cf. and fur:

    Data on the impact of Afloderm® on the ability to drive vehicles and mechanisms are not available.

    Form release / dosage:

    Cream for external use 0,05%.

    Packaging:

    For 20 and 40 grams of cream in aluminum tubes. The tube opening is protected by a membrane. The tube is closed with a polyethylene cap with a perforator for the membrane. Each tube is placed in a cardboard box together with instructions for use.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children!

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012153 / 02
    Date of registration:18.08.2010 / 20.04.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia
    Manufacturer: & nbsp
    Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia
    Information update date: & nbsp20.09.2017
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