Adolen® (Adolen)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAdapalenAdapalen
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    • Dosage form: & nbspgel for external use
    Composition:

    Per 100 g:

    Active substance: adapalene 0.1 g.

    Excipients: propylene glycol 5.0 g, carbomer (carbopol) 1.1 g, methyl parahydroxybenzoate (methyl paraben) -0.10 g, disodium edetate (ethylenediamine-tetraacetic acid disodium salt [trilon B]) 0.1 g, poloxamer 188 - 0.2 g, phenoxyethanol - 0.25 g, sodium hydroxide (sodium hydroxide) - 0.2 g, purified water - up to 100 g.

    Description:The gel is white.
    Pharmacotherapeutic group:Acne rash remedy
    ATX: & nbsp

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

    D.10.A.D.03   Adapalen

    Pharmacodynamics:

    Adapalene is a metabolite of the retinoid, which acts on the pathological mechanism of development Acne vulgaris, being a strong modulator of cellular differentiation and keratinization and has a comedonolytic and anti-inflammatory activity.

    The mechanism of action of adapalene is based on interaction with specific γreceptors of epidermal skin cells.As a result of the action of adapalene, the "cohesiveness" of epithelial cells in the mouth of the sebaceous-hair follicle decreases and the formation of micro-medones decreases.

    Adapalene has an anti-inflammatory effect in vivo and in vitro, acting on inflammatory factors by inhibiting the migration of leukocytes in the inflammatory focus, inhibiting the chemotactic and chemokinetic responses of polymorphonuclear human leukocytes and suppressing the metabolism of arachidonic acid to inflammatory mediators, AP-1 factors and expression Toll-like receptors 2.

    Pharmacokinetics:

    Absorption of adapalene through the skin is very low (about 4% of the applied dose). Excretion from the body occurs mainly through the intestine.

    Indications:

    Acne rashes of mild and moderate severity, including those with comedones, papules and pustules.

    If necessary, please consult with your doctor before using the medication.

    Contraindications:

    - Hypersensitivity to adapalene or any of the excipients;

    - Children under 12 years of age (efficacy and safety of the drug for this age group is not established).

    Carefully:There is no information.
    Pregnancy and lactation:

    Pregnancy

    Clinical experience of external application of adapalene in pregnancy is limited, but the available data in patients who received the drug in the early stages of pregnancy do not indicate its negative effect on the course of pregnancy or on the health of the fetus.

    Due to the limited nature of the available data, as well as the possibility of insignificant penetration of adapalene through the skin, the Adolen preparation® Do not use during pregnancy.

    In case of pregnancy, treatment should be discontinued.

    Breastfeeding period

    Studies of the penetration of the drug into human milk or animals have not been carried out after application to the skin.

    Since the systemic exposure of the drug Adolen® in lactating women is negligible, it is not expected that there will be any effect on children who are breastfeeding. The drug Adolen® can be used during breastfeeding.

    To avoid contact of the infant with the drug with the drug Adolen® During breastfeeding, care should be taken not to apply to the breast area.

    Dosing and Administration:

    For external use only.

    The gel should be applied in a thin layer to the acne affected areas of the skin once a day before going to bed on clean, dry skin, avoiding the gel in the eyes, lips, mucous membranes and nasal corners.

    A marked clinical improvement develops after 4-8 weeks of treatment, a persistent improvement after a 3-month course of treatment.

    Since the treatment of acne is an alternation of methods of therapy, after 3 months of therapy with the drug is recommended to consult with a doctor about further therapy.

    If there is no improvement after treatment or new symptoms appear, it is necessary to consult a doctor.

    Use the drug only according to the method of administration and the doses specified in the instructions. If necessary, please consult with your doctor before using the medication.

    Side effects:

    The drug Adolen® can cause the following undesirable drug reactions:

    Class of organ systems (MedDRA)

    Frequency of occurrence

    Unwanted drug reaction

    Disturbances from the skin and subcutaneous tissues

    Often (≥1 / 100 to <1/10)

    Dry skin, skin irritation, burning sensation of the skin, erythema

    Infrequently (≥1 / 1000 to <1/100)

    Contact dermatitis, discomfort, sunburn, itching, skin peeling, acne

    Frequency unknown *

    Allergic dermatitis (allergic contact dermatitis), tenderness of the skin, swelling of the skin, irritation of the eyelids, erythema eyelids, itchy eyelids, swelling of the eyelids

    * Post-registration data.

    If any of the side effects listed in the manual are aggravated or any other side effects not indicated in the instructions are noted, the doctor should be informed immediately.

    Overdose:

    Excessive application of the drug on the skin will not lead to a more rapid achievement of the result or a more pronounced effect, however, reddening, flaking or discomfort may develop.

    Adolen® Gel is for external use only. If you accidentally swallow even a small amount of the drug, you should rinse the stomach, if necessary, conduct symptomatic therapy.

    Interaction:

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

    There are no interactions with other drugs that can be used externally and simultaneously with the drug Adolen®.

    When using Adolene gel in the evening, in the morning, you can use such drugs for external treatment of acne, such as solutions of erythromycin (up to 4%) or clindamycin phosphate (1% based on base) or benzoyl peroxide gels on water basis (up to 10% ), because these drugs do not cause mutual degradation or cumulative irritation. However, other retinoids or drugs with a similar mechanism of action should not be used concomitantly with adapalene.

    Simultaneous use of the drug Adolen® and means for peeling, abrasive cleansers, as well as products with drying, astringent or irritating action (aromatic or alcohol-containing products) is not recommended.

    Special instructions:

    If susceptibility to the development of a reaction of hypersensitivity or severe form of skin irritation should stop using the drug.

    In some cases, depending on the degree of skin irritation, the number of applications may be reduced or the treatment suspended until the signs of irritation disappear.Renewal of treatment is possible after consultation with a doctor.

    Avoid contact with the eyes, mouth, nasal corners and mucous membranes. If you accidentally get the drug on the mucous membranes of the eyes, you should wash them with warm water.

    The drug should not be applied to injuries resulting from injuries (cuts and abrasions), sunburn or eczematous skin.

    Do not use adapalen in monotherapy in patients with severe form of acne on large areas of the skin.

    To avoid skin irritation with adapalene, it is necessary to minimize exposure to sunlight and artificial ultraviolet irradiation, including sunlight. If it is not possible to avoid exposure, we recommend the use of sunscreen products and clothing to protect the treated skin areas.

    When applying the drug Adolen® it is possible to use cosmetics that do not have comedogenic or astringent properties.

    The Adolen® gel contains methyl aryl hydroxybenzoate (E218), which can cause allergic reactions during or after treatment, and propylene glycol,which can be irritating to the skin.

    Read the instructions carefully before using the product. Keep the manual, it may be needed again. If you have any questions, contact your doctor. The medicine you are treating is intended for you personally, and it should not be passed on to others, as it can harm them even if you have the same symptoms as you.

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

    Gel Adolen® does not affect the ability to manage vehicles and work with mechanisms.

    Form release / dosage:Gel for external use, 0.1%.
    Packaging:

    By 3 g, 5 g, 10 g, 15 g or 30 g in tubes of aluminum or laminate.

    1 The tube is placed in a pack of cardboard for instructions.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-000784
    Date of registration:03.10.2011 / 04.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:VELFARM, LLC VELFARM, LLC Republic of San Marino
    Manufacturer: & nbsp
    Information update date: & nbsp09.02.2017
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