Xamiol, gel 15 g

Pharmgroup:

Psoriasis treatment.

Pharmic action:

Xamiol is a combination drug for the treatment of psoriasis.

Calcipotriol is a synthetic analogue 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 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

mild to moderate psoriasis in other parts of the body;
psoriasis of the scalp.

Pharmacological effect

Pharmaceutical group:

psoriasis treatment.

Pharmaceutical action:

Xamiol is a combination drug for the treatment of psoriasis.

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

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

Pharmacokinetics:

When using the drug 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 to form glucuronides and sulfoesters, excretion is carried out through the intestines and kidneys.

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, undesirable side reactions may occur in the form of irritation of the eyes and skin of the face, conjunctivitis. In case of accidental contact with eyes, rinse them with running water.

After applying the drug, you must wash your hands.

If secondary infections develop, antimicrobial therapy must be prescribed. Discontinuing treatment of psoriasis with topical corticosteroids may be associated with the risk of developing generalized pustular psoriasis and withdrawal effects. Therefore, after stopping 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 irradiation only in cases where the attending physician considers the risk of unwanted side effects associated with such treatment justified.

XAMIOL® contains butylated hydroxytoluene (E321), which may cause local skin reactions (for example, 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 treating lesions of the scalp) immediately after using the drug.

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

No effect.

Active ingredient

Betamethasone, Calcipotriol

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).

Excipients:

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

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

hydrogenated castor oil 20 mg.

Pregnancy

During pregnancy, XAMIOL® is used only if the expected 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 avoid breastfeeding.

Contraindications

Hypersensitivity to any of the components of the drug;
severe renal and liver failure;
diseases accompanied by calcium metabolism disorders;
psoriatic erythroderma, guttate, exfoliative, pustular psoriasis;
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 area and in the genital area, increased fragility of skin vessels, ichthyosis, stretch marks;
age up to 18 years.

Side Effects

Side effects are classified depending on the frequency of occurrence:

most common > 1/10;
frequent > 1/100 and < 1/10; uncommon > 1/1000 and < 1/100; rare > 1/10000 and < 1/1000; very rare < 1/10000.

Eye disorders: uncommon – eye irritation.

From the skin and skin appendages: frequent – itching; uncommon – 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 sensations, dry skin, erythema, rash, dermatitis, eczema, exacerbation of psoriasis, 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, colloid degeneration of the skin, as well as an increased risk of developing 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 function, cataracts, infections, increased intraocular pressure. Systemic reactions occur more often 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 skin.

Interaction

Not known.

Overdose

Symptoms: increased calcium levels in the blood; when the drug is stopped, 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 carry out symptomatic therapy. In cases of chronic toxicity, GCS should be discontinued gradually.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Manufacturer

LEO Laboratories Limited, Ireland