Daivobet, ointment, 15g

Composition

1 g of ointment contains: Active ingredients: calcipotriol monohydrate 0.052 mg, equivalent to calcipotriol 0.050 mg; betamethasone dipropionate 0.643 mg, equivalent to betamethasone 0.500 mg; Excipients: liquid paraffin 30.0 mg, polypropylene glycol stearate 50.0 mg, alpha-tocopherol 0.02 mg, soft white paraffin up to 1.0 g

Pharmacological action

Pharmacodynamics

Calcipotriol is a synthetic analog of the active metabolite of vitamin D. Causes inhibition of keratinocyte proliferation and accelerates their morphological differentiation.

Betamethasone is a glucocorticosteroid (corticosteroid) for external use. It has local anti-inflammatory, antipruritic, vasoconstrictor and immunosuppressive effects, but the exact mechanisms of the anti-inflammatory effect of topical corticosteroids are not fully clear. The use of occlusive dressings enhances the effect of topical corticosteroids, as this increases their penetration into the skin itself.

Pharmacokinetics

Suction and distribution

When using Daivobet, the absorption of calcipotriol and betamethasone through intact skin is less than 1%. When the drug is applied 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 elimination

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

Indications

Chronic vulgar plaque psoriasis.

Use during pregnancy and lactation

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

Contraindications

• Diseases associated with impaired metabolism of calcium;
• severe renal and hepatic failure;
• viral (including herpes or chickenpox ) infection;
• fungal skin infection;
• bacterial infection of skin,
• parasitic infection of skin;
• rosacea;
• rosacea;
• acne vulgaris;
• perioral dermatitis;
• cutaneous manifestations of tuberculosis and syphilis;
• atrophy of the skin;
• ulcers of the skin;
• increased fragility of blood vessels of the skin;
• ichthyosis;
• perianal and genital itching;
• psoriatic erythroderma;
• teardrop-shaped, exfoliative, pustular psoriasis;
• hypersensitivity to the components of the drug.

Side effects

Side effects are classified according to the frequency of occurrence:

• most frequent > 1/10. >
• frequent >1/100 and >< 1/10.
• infrequent > 1/1000 and >< 1/100.
• rare > 1/10 000 and >
• 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 disorder at the site of application of the ointment, folliculitis; rare-pustular psoriasis. Calcipotriol may cause local skin irritation, itching, burning, acute pain, dry skin, erythema, rash, dermatitis, eczema, and psoriasis exacerbation. Long-term topical use of betamethasone (dipropionate) is associated with the development of skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloidal skin degeneration, as well as an increased risk of generalized pustular psoriasis, hyper – and photosensitivity reactions, including extremely rare cases of angioedema and facial edema.

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

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

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Interaction

To date, the drug interaction of Daivobet has not been described.

How to take, course of use and dosage

• Adults: externally, the ointment is applied in a thin layer to the affected areas of the 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 body surface.

Overdose

Symptoms: increased calcium content in the blood, suppression of the pituitary-adrenal system with the development of reversible secondary adrenal insufficiency.

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

other information.

Special instructions

It is not recommended to apply the ointment on the face, mucous membranes and scalp. After using the drug, wash your hands.

The risk of hypercalcemia is minimal if the recommended dosage regimen is followed. However, when using Daivobet in doses exceeding the recommended maximum weekly dose (100 g), hypercalcemia may develop, which quickly passes when the dose is reduced or the drug is discontinued.

Daivobet contains potent corticosteroids, so it is not recommended to conduct concomitant treatment with other corticosteroids during its use.

Avoid using the drug on large areas of the skin that make up more than 30% of the body surface, as well as under an occlusive dressing, apply in the folds of the skin, because this increases the likelihood of systemic absorption of corticosteroids and the development of systemic adverse reactions.

If psoriasis is complicated by a secondary infection, antibacterial therapy should be performed, and if the infection worsens, the drug should be discontinued.

During treatment with Daivobet, excessive exposure to natural or artificial sunlight should be limited or avoided. The use of Daivobet in combination with UV radiation is only possible if the potential benefits outweigh the potential risks.

Use in pediatrics

There is no clinical experience with the use of Daivobet in children and adolescents under 18 years of age.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Daivobet does not affect the ability to drive vehicles and manage mechanisms.

Form of production

Ointment for external use

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Betamethasone, Calcipotriol

Dosage form

ointment

Description

For adults

Indications

Psoriasis, Allergies