Effezel (Effezel)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAdapalene + Benzoyl PeroxideAdapalene + Benzoyl Peroxide
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  • Effezel
    gel externally 
    Galderma S.A.     Switzerland
    • Dosage form: & nbspgel for external use
    Composition:

    In 1 g of gel contains:

    Active substances: Adapalene 0.001 g of benzoyl peroxide 0.025 g

    Excipients: simulgel 600 PHA (copolymer of acrylamide and acryloyl dimethyl taurate 35-40%, isohexadecane 20-25%, polysorbate 80 5-10%, sorbitan oleate 2.5%, water up to 100%) 0.04 g, docusate sodium 0.0005 g, disodium edetate 0.001 g, glycerol 0.04 g, poloxamer 124 0.002 g, propylene glycol 0.04 g, purified water up to 1 g.

    Description:

    White or very slightly yellow opaque gel.

    Pharmacotherapeutic group:Treatment for acne
    ATX: & nbsp

    D.10.A.D.   Preparations for the treatment of acne for external use containing retinoids

    D.10.A.D.53   Adapalene in combination with other drugs

    Pharmacodynamics:

    Effehzel contains in its composition two active substances with different, however complementary, mechanisms of action.

    Adapalen. Adapalen is a chemically stable naphthoic acid derivative with retinoid-like action. Adapalen is pathogenetic in asp vulgaris: is a strong modulator of the processes of cell differentiation and keratinization, and also has an anti-inflammatory effect.The mechanism of action of the drug is based on the binding of adapalene to specific nuclear receptors of retinoic acid. Modern data suggest that when applied locally adapalen normalizes the process of differentiation of epithelial cells of follicles, thereby reducing the formation of microcosmodes. In vitro adapalene inhibits the chemotactic (directional) and chemokinetic (arbitrary) responses of polymorphonuclear human leukocytes, and also inhibits the metabolism of arachidonic acid and the formation of inflammatory mediators. According to research in vitro Adapalene suppresses AP-1 factors, as well as expression toll-like receptors-2. Thus, it can be said that under the influence of adapalene, the cellular-mediated inflammatory component of acne is reduced.

    Benzoyl peroxide. Benzoyl peroxide has an antimicrobial effect, in particular with respect to Propionibacterium acnes, present in the sebaceous-hair follicle with acne. Has exfoliating and keratolytic action. Has a sebostatic effect, preventing excessive production of sebum accompanying acne.

    Pharmacokinetics:

    Pharmacokinetic properties of the drug Effezzel are similar to the pharmacokinetics of the drug Differin (adapalen) 0,1% gel for external use.

    Penetration of benzoyl peroxide through the skin is low. It is completely converted to benzoic acid, which is quickly eliminated from the body.

    Indications:

    Local treatment of acne with comedones, papules and pustules.

    Contraindications:

    Hypersensitivity or allergic reactions to active ingredients or any of the ingredients of the drug.

    Carefully:

    The safety and efficacy of the drug has not been investigated in children younger than 12 years.

    Pregnancy and lactation:

    Pregnancy

    Data on topical application of the combination of adapalene and benzoyl peroxide in pregnant women is not enough. However, several available data collected from patients who received the drug in the early stages of pregnancy, do not indicate any of its negative effects.

    Studies of the combination of adapalene and benzoyl peroxide on animals in which the drug was fed to the animals orally showed toxic effects on the reproductive system at high system exposure.

    Due to the limitations of the available data, as well as due to the possible weak penetration of adapalene through the skin, Effezzel should not be used during pregnancy. In case of pregnancy, treatment should be discontinued.

    Lactation

    Investigations of the penetration of the drug into the milk of animals or humans after the ephemezel has not been applied. Since the systemic exposure of Effexel in lactating women is negligible, no impact on breast-fed infants is expected.

    Effezel can be used during breastfeeding. Avoid contact of the newborn with the drug, applying the drug to the breast when used during breastfeeding.

    Dosing and Administration:

    Outwardly.

    Apply a thin film with the fingertips to the entire affected surface once a day in the evening on a clean and dry skin, avoiding contact with the eyes and mucous lips.

    The therapeutic effect develops after 1-4 weeks of treatment. The duration of treatment should be determined by the doctor on the basis of the clinical condition of the patient.

    In case of signs of skin irritation, the use of non-medigens with moisturizing effect is recommended, the number of applications can be reduced (for example, every other day), the treatment can be temporarily suspended until signs of irritation disappear or completely discontinued.

    Side effects:

    The frequency of side effects is distributed in the following order: often (in 1% - 10% of cases); infrequently (in 0.1% -1% of cases).

    From the skin and subcutaneous fat:

    Often: dry skin, irritable contact dermatitis, burning and irritation of the skin.Infrequent: itching, sunburn.
    Frequency unknown (postmarketing data): allergic contact dermatitis.

    In case of development of skin irritation, its intensity is usually mild or moderate, with local symptoms of tolerance (redness, dryness, flaking and burning) that reach a peak during the first week of treatment, and then spontaneously leave.

    Overdose:

    Use Effexel only once a day.

    If swallowed accidentally, appropriate symptomatic therapy should be given.

    Interaction:

    There have been no studies of interaction with other drugs.

    Based on the experience of using adapalene and benzoyl peroxide, interactions with other drugs have not been identified.

    However, do not use other retinoids at the same time or benzoyl peroxide, or drugs with a similar mechanism of action. Care should be taken when applying cosmetic products simultaneously with exfoliating, irritating or drying effects due to the possible additional irritating effect.

    Absorption of adapalene through the skin is low, so the development of interaction with systemic drugs is unlikely.

    Penetration of benzoyl peroxide through the skin is low, it is completely metabolized to benzoic acid, which is quickly eliminated from the body. In this regard, the development of interaction of benzoic acid with systemic drugs is unlikely.

    Special instructions:

    Do not apply Effegel gel to injuries resulting from injuries (cuts or abrasions) or eczematically altered skin.

    Avoid contact with eyes, mouth, nostrils and other mucous membranes. In case of contact with eyes, rinse immediately with warm water.The drug contains propylene glycol (E1520), which can cause skin irritation. If suspicion of increased sensitivity to any of the ingredients of the drug, Effexel should be discontinued.

    Excessive exposure to sunlight or UV radiation should be avoided.

    Avoid contact with any colored materials (including hair and dyed fabrics), as this can lead to discoloration or discoloration.

    Form release / dosage:Gel for external use 1 mg / g + 25 mg / g.
    Packaging:

    Gel for external use 1mg / g + 25mg / g for 2, 15, 30, 45, 60 and 90 g in a tube laminated from plastic with a top of high-density polyethylene or in a tube of high-density polyethylene, with a screwed polypropylene lid. One tube together with the instruction for use is placed in a cardboard box.

    Storage conditions:

    At a temperature not exceeding 30 ° C Keep out of the reach of children!

    Shelf life:

    2 years; After opening the tube is kept at least 6 months. Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:PL-000738
    Date of registration:29.09.2011
    The owner of the registration certificate: Galderma S.A. Galderma S.A. Switzerland
    Manufacturer: & nbsp
    Representation: & nbspGALDERMA, LLCGALDERMA, LLCRussia
    Information update date: & nbsp29.09.2011
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