Daivobet, ointment 15 g

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 lucocorticosteroid (GCS) for external use. It has local anti-inflammatory, antipruritic, vasoconstrictor and immunosuppressive effects, but the exact mechanisms of anti-inflammatory action of topical GCS are not fully understood. The use of occlusive dressings enhances the effect of topical GKS, as it increases their penetration into the skin proper.

Pharmacokinetics

Absorption 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, absorption of the topical GCS is increased. Because a depot of the drug is created in the skin, it is eliminated from the skin within a few days.

Metabolism and excretion

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

Indications

Allergies, Skin itching, Psoriasis, Dry skin

Chronic vulgar plaque psoriasis.

Active ingredient

Betamethasone, Calcipotriol

How to take, the dosage

• Adults: apply the ointment externally in a thin layer on the affected skin areas once a 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 carry out repeated courses of treatment under the supervision of a physician.

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

Interaction

To date, drug interactions of the drug Daivobet have not been described.

Special Instructions

It is not recommended to apply the ointment to the face, mucous membranes and the scalp. Wash hands after using the drug.

The risk of hypercalcemia is minimal if the recommended dosing regimen is followed. However, when using Daivobet in doses higher than the recommended maximum weekly dose (100 g), hypercalcemia may occur, which disappears quickly if the dose is reduced or the drug is discontinued.

Diveobet contains a potent GKS, so concomitant treatment with other GKS is not recommended during its use.

Application of the drug in large areas of skin over 30% of the body surface should be avoided, as well as under an occlusive dressing and applied in skin folds, because this increases the possibility of systemic absorption of the GCS and development of systemic adverse reactions.

If psoriasis is complicated by a secondary infection, antibiotic therapy should be given, and if the infection worsens, the drug should be withdrawn.

During treatment with Daivobet, excessive exposure to natural or artificial sunlight should be limited or avoided. The use of Daivobet in conjunction with UV radiation is possible only if the potential benefit outweighs the potential risk.

Pediatric use

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

Impact on ability to drive and operate vehicles and other mechanisms requiring increased concentration

Diveobet does not affect the ability to drive and operate machinery.

Contraindications

• Diseases accompanied by impaired calcium metabolism;
• explicit renal and hepatic failure;
• viral (including herpes or varicella) infections;
• fungal skin infections;
• bacterial skin infections;
• rosacea;
• painful acne;
• vulgar acne;
perioral dermatitis;
• dermal manifestations of tuberculosis and syphilis;
• skin atrophy;
• dermal ulcers;
• increased fragility of skin vessels;
• itis;
perianal and genital itching;
• psoriatic erythroderma;
• dropsy, exfoliative, pustular psoriasis;
• high sensitivity to the components of the drug.

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Side effects

Side effects are classified according to frequency of occurrence:

• frequent > 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.

Skin and skin appendages: frequent – itching, rash, burning sensation; infrequent – pain, irritation, dermatitis, erythema, psoriasis exacerbation, pigmentation disorders at the site of ointment application, folliculitis; rare – pustular psoriasis.

Calcipotriol may cause local skin irritation, itching, burning, severe pain, dry skin, erythema, rash, dermatitis, eczema and exacerbation of psoriasis. Prolonged topical use of betamethasone (dipropionate) is associated with the development of skin atrophy, telangiectasia, stretch marks, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, colloidal skin degeneration, and increased risk of generalized pustular psoriasis, hyper- and photosensitivity reactions, including extremely rare cases of angioedema and facial edema.

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

Side effects such as hypothalamic-pituitary-adrenal suppression with development of reversible secondary adrenal insufficiency or exacerbations of diabetes associated with systemic GCS administration may also be seen with long-term use of topical GCS due to systemic absorption.

Overdose

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

Treatment: discontinuation of the drug; if necessary symptomatic therapy is carried out. In cases of chronic toxicity, GCS should be withdrawn gradually.

Pregnancy use

The safety of Daivobet during pregnancy and lactation has not been established, so the drug may be used only if, in the physician’s opinion, therapy with its use is necessary.

Similarities

Xamiol