Xamiol gel for external use 30 g
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Active ingredients
Calcipotriol
Release form
Gel
Composition
Active ingredient: betamethasone 0.5 mg, calcipotriol 0.05 mg Auxiliary substances: liquid paraffin (contains about 10 ppm of alpha-tocopherol) 820 mg, polypropylene glycol stearate (PPG - 15) (contains 0, 1% butylhydroxytoluene) 160 mg, castor oil hydrogenated 20 mg. Base volume: 1 g Active substance concentration (mg): 0.55 mg
Pharmacological effect
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; has a 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 corticosteroids, 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 GCS increases. Since a depot preparation is created in the skin, it is eliminated from the skin within a few days. Betamethasone is metabolized in the liver and in the kidney to form glucuronides and sulfoesters, excreted through the intestines and kidneys.
Indications
Psoriasis of the scalp. Psoriasis is mild to moderate in other parts of the body.
Contraindications
Hypersensitivity to any of the components of the drug, diseases associated with impaired calcium metabolism, severe renal and hepatic failure, viral (herpes, shingles), fungal, bacterial and parasitic infections of the skin, rosacea, acne rosacea, acne, perioral dermatitis, skin manifestations tuberculosis and syphilis, skin atrophy, ulcers, wounds, itching in the perianal and genital areas, increased fragility of skin vessels, ichthyosis, stretch marks, psoriatic erythroderma, guttate, e Xfoliative, pustular psoriasis, age up to 18 years.
Precautionary measures
Use with caution when applied to the skin of the face and genitals.
Use 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 necessary, use of the drug during lactation is recommended to refuse breastfeeding.
Dosage and administration
Externally. Use in adults Before using the drug, the vial should be shaken. The gel is applied with a thin layer to the affected areas of the scalp or psoriatic plaques of other parts of the body 1 time per day. The maximum daily dose of 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 damage to the skin 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 overnight or day to achieve the optimal therapeutic effect. Perhaps repeated use of the drug Xamiol under the supervision of a physician.
Side effects
Side effects are classified by frequency: most frequent> 1/10; frequent> 1/100 and <1/10; infrequent> 1/1000 and <1/100; rare> 1/10000 and <1/1000; very rare <1 / 10,000. Eye disorders: infrequent - eye irritation. From the skin and skin appendages: 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, exacerbation of psoriasis, hyper and photosensitivity reactions, including very rare cases of angioedema and swelling of the face. The development of skin atrophy, telangiectasia, stretch marks, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloid degeneration of the skin, as well as an increased risk of developing generalized pustular psoriasis, and the increase in the risk of developing generalized pustular psoriasis are associated with prolonged external use of betamethasone (dipropionate), as well as increasing the risk of developing generalized pustular psoriasis. (very rare) - hypercalcemia or hypercalciuria; associated with the use of betamethasone (rare, but sometimes heavy, especially with prolonged use, on large surfaces and with the use of occlusive dressings) - suppression of the function of the adrenal cortex, cataracts,infections, increased intraocular pressure. Systemic reactions occur more frequently when applying the drug under occlusive dressings and when applied to thin skin and skin folds, as well as during prolonged treatment when applied to large areas of skin.
Overdose
Symptoms: increased calcium in the blood, with the cessation of the use of the drug is quickly restored; suppression of the function of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency. Treatment: cancel the drug and conduct symptomatic therapy. In cases of chronic toxicity, GCS should be phased out.
Interaction with other drugs
Not known
special instructions
Do not use the drug on mucous membranes. In case of accidental contact with eyes, undesirable side reactions are possible in the form of irritation of the eyes and skin of the face, conjunctivitis. In case of accidental eye contact, they should be washed with running water. Hands should be washed after applying the drug. When secondary infections develop, antimicrobial therapy should be prescribed. Termination of psoriasis treatment with local corticosteroids can be associated with the risk of generalized pustular psoriasis and the effect of withdrawal. Therefore, after discontinuation of such treatment, it is necessary to continue clinical observation of the patient. During the period of treatment with Xamiol, it is recommended that the patient limit or avoid excessive exposure to natural or artificial sunlight. Calcipotriol (and preparations containing it) are allowed to be applied topically in combination with ultraviolet irradiation only when the attending physician considers justified the risk of undesirable side effects associated with such treatment. Xamyol contains butylhydroxytoluene (E321), which can 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 hair (in the case of orazheny scalp) immediately after use preparata.Vliyanie on the ability to drive vehicles and management mehanizmamiNe affected.