Xamiol, gel 30 g

Pharmgroup:

The treatment for psoriasis.

Pharmic effect:

Xamiol is a combination drug for the treatment of psoriasis.

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 topical glucocorticosteroid (GCS) with local anti-inflammatory, antipruritic, vasoconstrictor and immunosuppressive effects, but the exact mechanisms of the anti-inflammatory effects of topical steroids are not fully understood.

The use of occlusive dressings enhances the effect of GCS because it increases 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 of other body parts
• psoriasis of the scalp.

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).

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 thinly to the affected areas of the scalp or to psoriatic plaques of other parts of the body once a day. Maximum daily dose should not exceed 15 g; maximum weekly dose should not exceed 100 g. Recommended duration of treatment course is 4 weeks for psoriasis of scalp and 8 weeks for skin lesions of other body parts. 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. 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 has determined that the risk of adverse events associated with this treatment 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.

Impact on ability to drive and operate vehicles and mechanisms requiring increased concentration

No effect.

Contraindications

• High sensitivity to any of the ingredients of the drug;
• expressed renal and hepatic failure;
• viral (herpes, herpes zoster, herpes zoster, fungi, bacterial and parasitic skin infectionsviral (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 area, increased fragility of skin vessels, ichthyosis, stretch marks;
• Diseases accompanied with impaired calcium metabolism.
• Psoriatic erythroderma, drop-shaped, exfoliative, pustular psoriasis
• Age before 18 years of age.

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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, striae, 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 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 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.

Pregnancy use

In pregnancy, XAMIOL® is used only if the estimated 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 stop breastfeeding.

Similarities

Daivobet