Xamiol gel d / nar ... approx. 15g

Gel for external use is practically transparent, from colorless to almost white

a thin oily film can be observed on the surface.

Pharmacodynamics

Calcipotriol is a synthetic analogue of the active metabolite of vitamin D. It inhibits the proliferation of keratinocytes and accelerates their morphological differentiation.

Betamethasone - a glucocorticosteroid (GCS) for external use

has a local anti-inflammatory, antipruritic, vasoconstrictor and immunosuppressive effect, however, the exact mechanisms of the anti-inflammatory action of steroids for external use are not fully understood.

The use of occlusive dressings enhances the effect of GCS, as this increases their penetration into the skin.

Pharmacokinetics

When using XAMIOL®, the absorption of calcipotriol and betamethasone through intact skin is less than 1%.

When applying the drug to psoriatic plaques and under occlusive dressings, the absorption of external corticosteroids increases.

Since a depot of the drug is created in the skin, its elimination from the skin occurs within several days.

Betamethasone is metabolized in the liver and kidneys with the formation of glucuronides and sulfoesters, excretion is carried out through the intestines and kidneys.

Indications

Psoriasis of the scalp.

Psoriasis of mild to moderate severity of other parts of the body.

Contraindications

Hypersensitivity to any component of the drug

diseases accompanied by impaired calcium metabolism

severe renal and hepatic failure

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

psoriatic erythroderma, teardrop, exfoliative, pustular psoriasis

age up to 18 years.

Application during pregnancy and lactation

During pregnancy, XAMIOL® is used only if the intended benefit to the mother outweighs the potential risk to the fetus.

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

special instructions

Do not use the drug on mucous membranes.

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

In case of accidental contact with the eyes, unwanted side reactions are possible in the form of irritation of the eyes and face skin, conjunctivitis.

In case of accidental contact with eyes, rinse them with running water.

Hands should be washed after applying the drug.

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

Discontinuation of psoriasis treatment with local corticosteroids may be associated with the risk of developing generalized pustular psoriasis and a withdrawal effect.

Therefore, after the termination of such treatment, it is necessary to continue clinical observation of the patient.

During the period of treatment with XAMIOL®, the patient is advised to limit or avoid excessive exposure to natural or artificial sunlight.

Calcipotriol (and preparations containing it) are allowed to be used topically in combination with ultraviolet radiation only in cases where the attending physician considers the risk of unwanted side effects associated with such treatment justified.

XAMIOL® 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, it is not recommended to take a shower / bath or wash your hair (in the case of treating lesions of the scalp) immediately after using the drug.

Influence on the ability to drive vehicles and mechanisms that require increased concentration

H

Name ENG

XAMIOL

Clinical and pharmacological group

Antiproliferative and anti-inflammatory drug for the treatment of psoriasis

ATX code

Calcipotriol in combination with other drugs

Dosage

0.5mg / g + 0.05mg / g x 15g

Structure

betamethasone dipropionate, equivalent to betamethasone, calcipotriol monohydrate, equivalent to calcipotriol.

Excipients: liquid paraffin 820 mg, polypropylene glycol stearate 160 mg, hydrogenated castor oil 20 mg.

Indications

Psoriasis of the scalp.

Psoriasis of mild to moderate severity of other parts of the body.

Contraindications

Hypersensitivity to any component of the drug

diseases accompanied by impaired calcium metabolism

severe renal and hepatic failure

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

psoriatic erythroderma, teardrop, exfoliative, pustular psoriasis

age up to 18 years.

INN / Active ingredient

Betamethasone, Calcipotriol

Storage conditions and periods

In a dark place, at a temperature not exceeding 25 degrees (do not store in a refrigerator).

Expiration date: 2 years

after opening - 6 months

Specifications

Category

Psoriasis

Scope of the drug

Dermatology

Release form

Gel

Manufacturer country

Denmark

Package quantity, pcs

one

Scope of application

Dermatology

Way of introduction

Outwardly

Vacation conditions

Without recipe

Brand name

Leo Pharmaceutical Products

The amount of the dosage form in the primary package

15 g

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Psoriasis cure

Anatomical and therapeutic characteristics

D05AX52 Calcipotriol, in combination with other drugs

Dosage form

Gel for external use

Item weight, g

15

Expiration date in days

730

Package weight, g

thirty

Mode of application

:

Outwardly.

Use in adults Before using the drug, the bottle must be shaken.

The gel is applied in a thin layer to the affected areas of the scalp or to psoriatic plaques of other parts of the body once a 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 for psoriasis of the scalp and 8 weeks for skin lesions on other parts of the body.

The area of ​​application of the drug should not exceed 30% of the body surface.

The drug should remain on the skin overnight or during the day for optimal therapeutic effect.

It is possible to re-use the drug Xamiol under medical supervision.

Dosage (volume) of the substance in the preparation

:

In 1 g: betamethasone dipropionate 643 mcg, - equivalent to betamethasone 500 mcg, calcipotriol monohydrate 52 mcg, - equivalent to calcipotriol 50 mcg

Information on technical characteristics, delivery set, country of manufacture