Dayvobet ointment, 15 g (betamethasone, Kaltsypotryol)

Release form

Ointment for external use.

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 is a lucocorticosteroid (GCS) for external use. It has a local anti-inflammatory, antipruritic, vasoconstrictive and immunosuppressive effect, however, the exact mechanisms of the anti-inflammatory effect of topical corticosteroids are not completely clear. The use of occlusive dressings enhances the effect of topical corticosteroids, as this increases their penetration into the skin itself.

Pharmacokinetics

Absorption and distribution of

When using Daivobet, 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 topical corticosteroids increases. Since a depot of the drug is created in the skin, its elimination from the skin occurs within a few days.

Metabolism and excretion

Betamethasone is metabolized in the liver and kidneys to form glucuronides and sulfoesters, excreted through the intestines and kidneys.

Indications

Chronic vulgar plaque psoriasis.

Contraindications

Disease, accompanied by impaired calcium metabolism

severe renal and hepatic insufficiency

viral infections (including herpes or chickenpox) infections

fungal infections of the skin

bacterial infections of the skin

parasitic infections of the skin

rosacea srdlkrdclergis dermatosis srdlkrdkrul dermatosis skin atrophy

skin ulcers

increased fragility of skin vessels

ichthyosis

perianal and genital itching

psoriatic erythroderma

teardrop, exf olivative, pustular psoriasis

hypersensitivity to the drug.

Use during pregnancy and lactation

The safety of Daivobet during pregnancy and lactation has not been established, so the use of the drug is possible only when, according to the doctor, therapy with its use is necessary.

Composition of

1 g of ointment for external use contains:

Active substances: betamethasone dipropionate 643 μg, equivalent to 500 μg betamethasone calcipotriol monohydrate 52 μg, equivalent to calcipotriol 50 μg.

Excipients: liquid paraffin, polyoxypropylene-15-stearyl ether,? -tocopherol, soft white paraffin.

Dosage and administration

Adults: ointment is applied externally with a thin layer to the affected skin 1 time / 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 is 4 weeks. It is possible to conduct repeated courses of treatment under the supervision of a doctor.

The area of ​​application of the drug should not exceed 30% of the surface of the body.

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> 1/10 000 and <1/1000.

very rare <1/10 000.

From the skin and appendages of the skin: frequent - itching, rash, burning sensation infrequent - pain, irritation, dermatitis, erythema, exacerbation of psoriasis, pigmentation disturbance at the site of application of the ointment, rare folliculitis - pustular psoriasis. Calcipotriol can cause local skin irritation, itching, burning, acute pain, dry skin, erythema, rash, dermatitis, eczema and exacerbation of psoriasis. The prolonged topical 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 generalized pustular psoriasis, hyper- and photo-reaction including extremely rare cases of angioedema and facial edema.

Systemic reactions: when using calcipotriol, a very rare side effect is hypercalcemia or hypercalciuria. Topical use of betamethasone is associated (rare, but sometimes severe, especially with prolonged use, on large surfaces and when using occlusive dressings): suppression of adrenal cortex function, cataracts, infections, increased intraocular pressure.

Adverse events such as suppression of the hypothalamic-pituitary-adrenal system with the development of reversible secondary adrenal insufficiency or exacerbation of diabetes mellitus associated with the systemic administration of GCS can also be observed with prolonged use of topical GCS due to systemic absorption.

Drug Interaction

The drug interaction of the drug Dibobet has not been described to date.

Overdose

Symptoms: Increased blood calcium, suppression of function of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency.

Treatment: withdrawal of the drug, if necessary, conduct symptomatic therapy. In cases of chronic toxicity, ACS should be discontinued gradually.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Expiration

2 years. After the first autopsy, the Expiration is 3 months.

Dosage form

Dosage form

ointment



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