Description
Release form
Gel for external use.
60
package.
Pharmacological action
Pharmacodynamics
Calcipotriol is a synthetic analogue of the active metabolite of vitamin D. It inhibits the proliferation of keratinocytes and accelerates their morphological differentiation.
Betamethasone – a glucocorticosteroid (GCS) for external use has a local anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive effect, however, the exact mechanisms of the anti-inflammatory effect of steroids for external use are not fully understood. The use of occlusive dressings enhances the effect of corticosteroids, as this increases their penetration into the skin.
Pharmacokinetics
With the use of 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 the external corticosteroids increases. Since a depot of the drug is created in the skin, its elimination from the skin occurs within a few days. Betamethasone is metabolized in the liver and kidneys with the formation of glucuronides and sulfoesters, excretion is carried out through the intestines and kidneys.
Indications
Psoriasis of the scalp. Psoriasis of mild to moderate severity of other parts of the body.
Contraindications
Hypersensitivity to any of the components of the drug
diseases accompanied by impaired calcium metabolism
severe renal and hepatic insufficiency
viral (herpes, shingles), fungal, bacterial and parasitic infections, rosacea, rosacea, rosacea, rosacea dermatitis, skin manifestations of tuberculosis and syphilis, atrophy of the skin, ulcers, wounds, itching in the perianal and genital areas, increased fragility of the skin vessels, ichthyosis, striae
psoriatic erythroderma, drop-shaped, exfoliative, pustular psoriasis
age under 18 years.
Use during pregnancy and lactation
During pregnancy, XAMIOL ® is used only if the expected benefits to the mother outweigh the potential risk to the fetus.
If it is necessary to use the drug during lactation, it is recommended to abandon breastfeeding.
Special instructions
Do not use on mucous membranes.
Use with caution when applied to the skin of the face and genitals.
In case of accidental contact with the eyes, unwanted adverse reactions are possible in the form of eye and face irritation, conjunctivitis. In case of accidental contact with eyes, rinse them with running water.
After applying the drug, wash your hands.
With the development of secondary infections, antimicrobial therapy should be prescribed. Discontinuation of treatment of psoriasis with local corticosteroids drugs may be associated with a risk of developing generalized pustular psoriasis and the effect of withdrawal. Therefore, after discontinuation of 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 the preparations containing it) is allowed to be applied topically in combination with ultraviolet radiation only in cases where the attending physician considers the risk of unwanted side effects associated with such treatment justified.
XAMIOL ® contains butylhydroxytoluene (E321), which can cause local skin reactions (e.g. 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 treatment of lesions of the scalp) immediately after using the drug.
Impact on the ability to drive vehicles and machinery requiring increased concentration of attention
Not affected.
Composition
1 g of gel contains:
Active ingredients: betamethasone dipropionate 0.643 mg (equivalent to betamethasone 0, 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% butylhydroxytoluene) 160 mg, hydrogenated castor oil 20 mg.
Dosage and Administration
Externally.
Adult use
Shake the vial before using the drug. 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 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 scalp psoriasis and 8 weeks for skin lesions of other parts of the body. The area of application of the drug should not exceed 30% of the surface of the body. The drug should remain on the skin during the night or day to achieve the optimal therapeutic effect. It is possible to re-use the drug Xamiol ® under the supervision of a doctor.
Side effects
Side effects are classified by frequency of occurrence: most common> 1/10
frequent> 1/100 and <1/10 infrequent> 1/1000 and <1/100 rare> 1/10000 and <1/1000 very rare <1/10000. Eye disorders: Infrequent – eye irritation. From the skin and appendages of the skin: 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 pinching, dry skin, erythema, rash, dermatitis, eczema, exacerbation of psoriasis, hypersensitivity and photosensitivity reactions, including very rare cases of angioedema and facial edema. The prolonged external use of betamethasone (dipropionate) is associated with the development of skin atrophy, telangiectasias, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloid skin degeneration, 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 prolonged use, on large surfaces and when using occlusive dressings) – suppression of adrenal cortex, cataracts, infections increased intraocular pressure. Systemic reactions occur more often 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 the skin. Drug Interactions Not known. overdose Symptoms: increased calcium content in the blood, when the drug is stopped quickly suppresses the function of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency. Treatment: cancel the drug and carry out symptomatic therapy. In cases of chronic toxicity, ACS should be discontinued gradually. Storage Conditions Do not store above 25 ° C. Do not refrigerate. Store in a cardboard box for protection against light. Keep out of the reach and sight of children. Shelf life 2 years. Deystvuyushtee substance Betamethasone, Kalytsipotriol Dosage form gel for external use Possible product names Ksamiol gel 60 g Leo Pharmaceutical, Denmark
