Xamiol, gel, 30g

Composition

Active ingredients:  

betamethasone dipropionate 0.643 mg (equivalent to betamethasone 0.5 mg) 

calcipotriol monohydrate 0.052 mg (equivalent to calcipotriol 0.05 mg).

Auxiliary substances:  

liquid paraffin (contains about 10 ppm alpha-tocopherol) 820 mg,

polypropylene glycol stearate (PPG – 15) (contains 0.1% butylhydroxytoluene) 160 mg,

hydrogenated castor oil 20 mg

Pharmacological action

Pharmaceutical group:

psoriasis treatment.

Pharmaceutical action:  

Xamiol is a combination drug for the treatment of psoriasis.

Calcipotriol is a synthetic analog of the active metabolite of vitamin D. Causes inhibition of keratinocyte proliferation and accelerates their morphological differentiation.

Betamethasone is a glucocorticosteroid (corticosteroid) for external use; it has local anti-inflammatory, antipruritic, vasoconstrictor and immunosuppressive effects, however, the exact mechanisms of the anti-inflammatory effect of steroids for external use are not fully clear.

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

Pharmacokinetics:

When using Xamiol, the absorption of calcipotriol and betamethasone through intact skin is less than 1%. When the drug is applied 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 a few 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

• Mild to moderate psoriasis of other parts of the body;
• psoriasis of the scalp.

Use during pregnancy and lactation

During pregnancy, XAMIOL® 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.

Contraindications

• Hypersensitivity to any component of the drug;
• pronounced renal and liver failure;
• viral (herpes, shingles), fungal, bacterial and parasitic infections of the skin, rosacea, acne rosacea, acne vulgaris, perioral dermatitis, cutaneous manifestations of tuberculosis and syphilis, skin atrophy, ulcers, wounds, itching in the perianal region and in the genital area, increased fragility of blood vessels of the skin, ichthyosis, striae;
• diseases accompanied by metabolic disorder of calcium;
• psoriatic erythroderma, teardrop, exfoliative, pustular psoriasis;
• the age of 18.

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

Eye disorders: infrequent-eye irritation.

From the skin and appendages of the skin: frequent-itching; infrequent-rash, burning sensation, pain, irritation, dermatitis, exacerbation of psoriasis, folliculitis, dry skin, acne, pustular psoriasis. Calcipotriol can cause local skin irritation, itching, burning and tingling, dry skin, erythema, rash, dermatitis, eczema, psoriasis exacerbation, hyper – and photosensitivity reactions, including very rare cases of angioedema and facial edema. Long-term external use of betamethasone (dipropionate) is associated with the development of skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloidal skin degeneration, as well as 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 when using occlusive dressings) – suppression of the function of the adrenal cortex, cataracts, infections, increased intraocular pressure. Systemic reactions occur more frequently when the drug is applied under occlusive dressings and when applied to thin skin and skin folds, as well as during long-term treatment when applied to large areas of the skin.

Interaction

Not known.

How to take, course of use and dosage

Externally.

Use in adults

Before using the drug, the bottle must be shaken. The gel is applied in a thin layer on the affected areas of the scalp or on psoriatic plaques of other parts of the body 1 time a day. The maximum daily dose should not exceed 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 of 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 during the night or day to achieve optimal therapeutic effect. Repeated use of Xamiol® is possible under medical supervision.

Overdose

Symptoms: increased calcium content in the blood, when the drug is discontinued, it quickly recovers; suppression of the function of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency.

Treatment: discontinue the drug and continue symptomatic therapy. In cases of chronic toxicity, corticosteroids should be discontinued gradually.

Special instructions

Do not use the product on the mucous membranes.

Use the product with caution when applied to the face and genitals.

In case of accidental contact with the eyes, undesirable side effects may occur in the form of eye and facial skin irritation, conjunctivitis. In case of accidental contact with the eyes, they should be rinsed with running water.

After applying the drug, you should wash your hands.

If secondary infections develop, antimicrobial therapy should be prescribed. Discontinuation of psoriasis treatment with topical corticosteroids may be associated with a risk of developing generalized pustular psoriasis and a withdrawal effect. Therefore, after discontinuation of such treatment, it is necessary to continue clinical monitoring of the patient.

During treatment with XAMIOL®, the patient is advised to limit or avoid excessive exposure to natural or artificial sunlight. Calcipotriol (and preparations containing it) is allowed to be used topically in combination with ultraviolet radiation only in cases where the attending physician considers the risk of undesirable side effects associated with such treatment to be justified.

XAMIOL contains butylhydroxytoluene (E 321), which may cause local skin reactions (e. g. contact dermatitis) or irritation of the eyes and mucous membranes.

To achieve an optimal therapeutic effect, it is not recommended to take a shower/bath or wash your hair (in the case of treatment of scalp lesions) immediately after using the drug.

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

It doesn’t affect you.

Product form

gel for external use

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Betamethasone, Calcipotriol

Dosage form

gel for external use