Expiration date: 03/2025
The composition and form of issue
Xamiol gel for external use
Active substances: betamethasone dipropionate 0,643 mg (equivalent to betamethasone 0.5 mg) calcipotriol monohydrate 0,052 mg (equivalent calcipotriol 0.05 mg)
Excipients: liquid paraffin (containing about 10 ppm of alpha-tocopherol) 820 mg, glycol stearate (PPG - 15) (containing 0.1% butylhydroxytoluene) 160 mg, hydrogenated castor oil 20 mg, in tube 15 and 30 g.
Pharmacological action:
Of calcipotriol - a synthetic analogue of the active metabolite of vitamin D. Causes inhibition of proliferation of keratinocytes and accelerates their morphological differentiation. Betamethasone is a glucocorticosteroid (GCS) for outdoor use, has a local anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive action, however, the exact mechanisms of anti-inflammatory action of the steroids for external application is not completely clear. The use of occlusive dressings increases the effect of corticosteroids, as this increases their penetration into the skin.
Indications:
Psoriasis of the scalp. Psoriasis mild and moderate severity of other parts of the body.
Contraindications:
- Diseases associated with impaired metabolism of calcium.
- Hypersensitivity to any component of the drug Xamiol.
- Severe renal and hepatic failure.
- Viral (herpes, shingles), fungal, bacterial and parasitic skin infections, rosacea, acne rosacea, acne vulgaris, perioral dermatitis, skin manifestations of tuberculosis and syphilis, skin atrophy, ulcers, wounds, itching in the perianal region and the genital area, increased fragility of the blood vessels of the skin, ichthyosis, striae.
- Psoriatic erythroderma, guttate, exfoliative, pustular psoriasis.
- The age of 18.
Application of pregnancy and breastfeeding
During pregnancy Xamiol used only if the expected benefit to the mother outweighs the potential risk to the fetus. If necessary, the use of the drug during lactation is recommended to abandon breastfeeding.
Method of application and doses
Externally.
The use in adults. Prior to use a vial should be shaken. The gel is applied thinly to the affected areas of the scalp or psoriatic plaques on other body parts 1 time per day. The maximum daily dose is not more than 15 g, the maximum weekly dose should not exceed 100 g. the recommended duration of treatment 4 weeks for psoriasis of the scalp and 8 weeks for the 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 optimum therapeutic effect. Possible re-use of the drug Xamiol under the supervision of a physician.
Side effects:
With the skin: itching, transient skin irritation at the site of application of ointment, dermatitis (including perioral and allergic contact), erythema, exacerbation of psoriasis, skin atrophy, telangiectasia, striae formation (especially prolonged use), folliculitis, hypertrichosis, hypopigmentation.
Systemic: hypercalcemia, suppression of adrenocortical function.
Special instructions:
It is not recommended to apply the drug to the skin. After applying the ointment, wash your hands.
It is recommended to avoid application of the preparation on extensive skin areas and under occlusive bandage, to be applied in skin folds, since it increases the probability of systemic absorption of corticosteroids.
When used in doses exceeding recommended possible hypercalcemia, quickly passing by reducing the dose or withdrawal.
Long-term use in the result of systemic absorption can be observed inhibition of the hypothalamic-pituitary-adrenal system with development of reversible secondary adrenal insufficiency or exacerbation of diabetes.
After prolonged use of the drug should be discontinued gradually.
Overdose:
Symptoms are: elevated levels of calcium in the blood, discontinuation of the drug is quickly restored, the suppression of the function of the pituitary-adrenal system with development of reversible secondary adrenal insufficiency.
Treatment: cancel the drug, symptomatic therapy. In cases of chronic toxicity, corticosteroids should be withdrawn gradually.
Storage conditions
At temperatures above 25 °C. Keep out of reach of children.
Shelf life - 2 years.
