betamethasone, Kaltsypotryol | Xamiol gel, 15 g

Release form

Gel for external use.

15 g

packaging

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.

Use during pregnancy and lactation

During pregnancy, XAMIOLВ® 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.

Composition of

1 g of gel contains:

Active substances: 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% 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 according to 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

is 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 function, cataract, infection, 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 interaction

Not known.

Overdose

Symptoms: Increased blood calcium, suppression of function of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency is rapidly restored when the drug is discontinued.

Treatment: cancel the drug and carry out symptomatic therapy. In cases of chronic toxicity, ACS should be discontinued gradually.

Storage conditions

Store at a temperature not exceeding 25 РC. Do not store in the refrigerator. Store in a cardboard box to protect from light.

Keep out of the reach of children.

Expiration

2 years.

Dosage form

dosage form

gel for external use

Leo Pharmaceutical, Denmark