Xamiol, gel 60 g

Pharmacodynamics

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

Betamethasone is a glucocorticosteroid (GCS) for external use; it has local anti-inflammatory, antipruritic, vasoconstrictor and immunosuppressive effects, but the exact mechanisms of anti-inflammatory action of external steroids are not fully understood. The use of occlusive dressings enhances the effect of GCS, 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, absorption of the external GCS is increased. Since a depot of the drug is created in the skin, it is eliminated from the skin within a few days. Betamethasone is metabolized in the liver and kidneys to form glucuronides and sulfoesters, excretion is through the intestine and kidneys.

Indications

Psoriasis of the scalp.

Mild to moderate psoriasis of other parts of the body.

Active ingredient

Betamethasone, Calcipotriol

Composition

1 g of the 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).

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.

How to take, the dosage

Externally.

Application in adults

The bottle should be shaken before use. 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 should not exceed 15 g; the maximum weekly dose should not exceed 100 g. Recommended duration of treatment course is 4 weeks for psoriasis of the scalp and 8 weeks for lesions of other parts of the body. Area of application of the drug should not exceed 30% of the body surface.

The drug should be left on the skin overnight or during the day for optimal therapeutic effect. Repeated use of Xamiol® is possible under a physician’s supervision.

Special Instructions

Do not use the product on mucous membranes.

Perhaps use with caution when applied to the face and genitals.

Inadvertent contact with the eyes may cause undesirable adverse reactions in the form of eye and facial skin irritation and conjunctivitis. If accidental contact occurs, the eyes should be rinsed with running water.

Wash hands after applying the drug.

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

During treatment with XAMIOL®, it is recommended that the patient limit or avoid excessive exposure to natural or artificial sunlight. Calcipotriol (and products containing it) should only be used topically in combination with ultraviolet light exposure when the treating physician determines the risk of undesirable side effects is justified.

CAMIOL® contains butylhydroxytoluene (E321) which can cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

In order to achieve optimal therapeutic effect, it is not recommended to shower/bath or wash hair (in case of scalp lesions) immediately after using the product.

Synopsis

A gel for external use

Contraindications

• Excessive sensitivity to any of the ingredients of the drug;
• diseases accompanied by impaired calcium metabolism;
• expressed renal and hepatic failure;
viral (herpes, herpes zoster), fungal, bacterial and parasitic skin infections, rosacea, pink acne, blackheads, perioral dermatitis, cutaneous manifestations of tuberculosis and syphilis, skin atrophy, ulcers, wounds, itching in the perianal and genital areas, increased fragility of skin vessels, ichthyosis, stretch marks;
• Psoriatic erythroderma, dropwise, exfoliative, pustular psoriasis
• Age
• under 18 years of age.

.

Side effects

Side effects are classified according to their frequency of occurrence:

• frequent > 1/10;
• frequent > 1/100 and < 1/10;
• rare > 1/10000 and < 1/1000;
• very rare < 1/10000.

Eye disorders: infrequent – eye irritation.

Skin and skin appendages: frequent – itching; infrequent – rash, burning sensation, pain, irritation, dermatitis, psoriasis exacerbation, folliculitis, dry skin, acne, pustular psoriasis.

Calcipotriol may cause localized skin irritation, itching, burning and tingling sensations, 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, stretch marks, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloidal skin degeneration, and 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 long-term use, on large surfaces and when using occlusive dressings) – suppression of adrenal cortical function, cataracts, infections, increased intraocular pressure.

Systemic reactions are more common when applied under occlusive dressings and when applied to thin skin and skin folds, and during long-term treatment when applied to large areas of skin.

Overdose

Symptoms: increase in blood calcium, upon discontinuation of the drug is quickly restored; suppression of pituitary-adrenal system function with the development of reversible secondary adrenal insufficiency.

Treatment: discontinue the drug and conduct symptomatic therapy. In cases of chronic toxicity, GCS should be withdrawn gradually.

Similarities

Daivobet