Xamol® (Xamiol®)

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

In 1 g of gel contains:

active ingredients: betamethasone dipropionate 0.643 mg (equivalent to betamethasone 0.5 mg), calcipotriol monohydrate 0.052 mg (equivalent to calcipotriol 0.05 mg);

Excipients: paraffin liquid (contains about 10 ppm alpha-tocopherol) 820 mg, polypropylene glycol stearate (PPG-15) (contains 0.1% butylhydroxytoluene) 160 mg, castor oil hydrogenated 20 mg.

Description:

Practically transparent, from a colorless to almost white color gel. A thin, oily film can be observed on the surface.

Pharmacotherapeutic group:psoriasis treatment
ATX: & nbsp
  • Calcipotriol in combination with other drugs
    • Pharmacodynamics:

    Calcipotriol - a synthetic analogue of the active metabolite of vitamin D. It causes inhibition of the proliferation of keratinocytes and accelerates their morphological differentiation.

    Betamethasone - Glucocorticosteroid (GCS) for external use; has a local anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive action, however the precise mechanisms of anti-inflammatory effects of steroids for external application are not completely clear. The use of occlusive dressings enhances the effect of GCS, so as this increases their penetration into the skin.

    Pharmacokinetics:

    When using the drug KSAMIOL®, the absorption of calcipotriol and betamethasone through intact skin is less than 1%. When the preparation is applied to psoriatic plaques and under occlusive dressings, the absorption of the external SCS increases. Since the depot is created in the skin, its elimination from the skin occurs within a few days. Betamethasone is metabolized in the liver and in the kidneys with the formation of glucuronides and sulfoesters, excretion is carried out through the intestine and kidneys.

    Indications:Psoriasis of the scalp.
    Psoriasis of mild and moderate severity of other parts of the body.
    Contraindications:

    Diseases accompanied by a violation of calcium metabolism.

    Hypersensitivity to any of the components of the drug.

    Pronounced renal and hepatic insufficiency.

    Viral (herpes, shingles), fungal, bacterial and parasitic skin infections, rosacea, rosacea, acne vulgaris, perioral dermatitis, cutaneous manifestations of tuberculosis and syphilis, skin atrophy, ulcers, wounds, itching in the perianal region and genital area,increased brittle skin vessels, ichthyosis, stria.

    Psoriatic erythroderma, teardrop, exfoliative, pustular psoriasis.

    Age to 18 years.

    Pregnancy and lactation:

    In pregnancy, KSAMIOL® is used only if the intended benefit to the mother exceeds the potential risk to the fetus.

    If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.

    Dosing and Administration:

    Outwardly.

    Application in adults. Before using the preparation, the vial should be shaken. The gel is applied a thin layer on the affected areas of the scalp or on psoriatic plaques of other parts of the body 1 time per day.

    The maximum daily dose is not more than 15 g; the maximum weekly dose should not exceed 100 g.

    The recommended duration of treatment is 4 weeks with psoriasis of the scalp and 8 weeks with lesions of the skin of other parts of the body. The application area should not exceed 30% of the body surface. The drug should remain on the skin for a night or a day to achieve the optimal therapeutic effect.

    It is possible to re-use the drug Xamiol® under the supervision of a doctor.

    Side effects:

    Side effects are classified according to the frequency of occurrence:

    most frequent> 1/10

    Frequent> 1/100 and <1/10

    infrequent> 1/1000 and <1/100

    rare> 1/10000 and <1/1000

    very rare <1/10000

    Disturbances from the eyes:

    Infrequent: eye irritation.

    From the skin and appendages of the skin:

    Frequent: itching.

    Infrequent: a rash, a burning sensation, pain, irritation, dermatitis, exacerbation of psoriasis, folliculitis, dry skin, acne, pustular psoriasis.

    Calcipotriol can cause local skin irritation, itching, burning sensation and tingling, dry skin, erythema, rash, dermatitis, eczema, exacerbation of psoriasis, hyper- and photosensitivity reactions, including very rare cases of angioedema and edema of the face.

    With prolonged external application, betamethasone (dipropionate) is associated with the development of skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloidal skin degeneration, and an increased risk of generalized pustular psoriasis.

    Systemic reactions:

    Associated with the use of calcipotriol (very rare): hypercalcemia or hypercalciuria.

    Associated with the use of betamethasone (rare but sometimes severe, especially with prolonged use, on large surfaces and with the use of occlusive dressings): suppression of adrenal cortex function, cataract, infection, increased intraocular pressure.

    Systemic reactions occur more often when the preparation is applied to occlusal dressings and when applied to thin skin and skin folds, and also during prolonged treatment when applied to large areas of the skin.

    Overdose:

    Symptoms: an increase in the content of calcium in the blood, when discontinuing the use of the drug is quickly restored; suppression of the function of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency.

    Treatment: abolish the drug and carry out symptomatic therapy. In cases of chronic toxicity, GCS should be discontinued gradually.

    Interaction:

    Unknown.

    Special instructions:

    Do not use the drug on the mucous membranes.

    Use with caution when applying to the skin of the face and genitals.

    In case of accidental ingestion, unwanted side reactions are possible in the form of irritation of the eyes and facial skin, conjunctivitis. In case of accidental contact with eyes, rinse them with running water.

    After applying the drug, you should wash your hands.

    With the development of secondary infections, antimicrobial therapy should be prescribed.

    Termination of psoriasis treatment with local GCS drugs may be associated with a risk of developing generalized pustular psoriasis and the effect of withdrawal. Therefore, after discontinuation of such treatment, it is necessary to continue clinical monitoring of the patient.

    During the treatment with KSAMIOL®, the patient is advised to limit or avoid excessive exposure to natural or artificial sunlight. Calcipotriol (and preparations containing it) are permitted to be applied topically in combination with ultraviolet irradiation only when the attending physician considers that the risk of undesirable side effects associated with such treatment is justified.

    The drug KSAMIOL® contains butylhydroxytoluene (E321), which can cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.

    To achieve the optimal therapeutic effect, do not take a shower / bath or wash your hair (in case of damage to the scalp) immediately after applying the drug.

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

    Does not affect.

    Form release / dosage:

    Gel for external use.

    Packaging:By 15, 30 or 60 g of gel per bottle of high-density polyethylene, equipped with a packing of low-density polyethylene and a screw cap made of high-density polyethylene; a two-page self-adhesive label is applied to the bottle; 1 bottle together with instructions for use in a cardboard box.
    Storage conditions:

    At a temperature of no higher than 25 ° C. Do not store in the refrigerator. Store in a cardboard box to protect from light.

    Keep out of the reach of children.

    Shelf life:

    2 years; after opening the bottle - 6 months.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001095
    Date of registration:03.11.2011
    Date of cancellation:2016-11-03
    The owner of the registration certificate:Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Denmark
    Manufacturer: & nbsp
    Representation: & nbspLEO Pharmaceutical Products Ltd.LEO Pharmaceutical Products Ltd.
    Information update date: & nbsp20.11.2015
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