DAJVOBET

Active material: Betametazon, Calcitriol
When ATH: D05AX02
CCF: With antiproliferative and anti-inflammatory effects for the treatment of psoriasis
ICD-10 codes (testimony): L40
When CSF: 04.05
Manufacturer: LEO PHARMACEUTICAL PRODUCTS (Denmark)

Pharmaceutical form, composition and packaging

◊ Ointment for external application uniform, from almost white to bledno-jeltogo color.

Excipients: Liquid paraffin, polioksipropilen--15 Stearyl ether, a-токоферол, white soft paraffin.

15 g – aluminum tuba (1) – packs cardboard.
15 g – polyethylene tubes (1) – packs cardboard.
30 g – aluminum tuba (1) – packs cardboard.
30 g – polyethylene tubes (1) – packs cardboard.
60 g – aluminum tuba (1) – packs cardboard.
60 g – polyethylene tubes (1) – packs cardboard.

Pharmacological action

Calcipotriol – synthetic analogue metabolita active vitamin D. Causes inhibition of proliferation of keratinocytes and accelerates their morphological differentiation of.

Betametazon – glukokorticosteroid (GCS) for outdoor use. Provides local anti-inflammatory, protivozudnoe, vazokonstrictornoe and immunosupressivne effect, However, the exact mechanisms of anti-inflammatory action topicheskih GKS is not clear. Occluzih casts increases the effect of SCS topicheskih, tk. This improves their penetration in the skin.

Pharmacokinetics

Absorption and distribution

When applying Dajvobeta^® suction calzipotriola and betametazon through intact skin is less than 1%. When the drug causing psoriatic plaques and under occluzie bandages increases absorption of topical CORTICOSTEROIDS.

Because the skin creates a depot medication, his elimination of the skin occurs within a few days.

Metabolism and excretion

Betamethasone is metabolized in the liver and kidney education glukuronidov and sul'fojefirov, return via intestine and kidneys.

Testimony

-chronic vulgar blachechny psoriasis.

Dosage regimen

Dajvobet^® appointed adult. External ointment are thin in areas affected skin 1 time / day.

The maximum daily dose is not more than 15 g, maximum weekly dose should not exceed 100 g.

The recommended duration of treatment – 4 of the week. Possibly re courses of treatment under medical supervision.

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

Side effect

Side effects are classified depending on the frequency of occurrence: the most frequent (> 1/10), frequent (>1/100 and < 1/10), infrequent (> 1/1000 and < 1/100), few (> 1/10 000 and < 1/1000), very rare (< 1/10 000).

For the skin and skin appendages: frequent – itch, rash, burning sensation; infrequent – pain, irritation, dermatitis, эritema, exacerbation of psoriasis, pigmentation on the application of ointment, folliculitis; few – pustular psoriasis.

Kaltsipotriol can cause local skin irritation, itch, burning, acute pain, xerosis, Erythema, rash, dermatitis, Eczema and worsening of psoriasis.

The long topicheskim the use of betamethasone (dipropionate) associated with the development skin atrophy, teleangiэktaziy, stretch marks, follikulita, hypertryhoza, perioral dermatitis, allergic contact dermatitis, depigmentation, colloid degeneration of the skin, as well as increase the risk of generalized pustular psoriasis, hyper reaction- and photosensitivity, including very rare cases of angioedema and facial edema.

Systemic reactions:

When using calcipotriol very rare side effect is hypercalcemia or hypercalciuria.

With topical application of betamethasone bind (few, but sometimes heavy, especially with prolonged use, on large surfaces and when using occluzih casts): Suppression of adrenal function, Cataract, infection, increased intraocular pressure.

Contraindications

- Diseases, accompanied by disturbance of calcium metabolism;

— expressed renal and liver failure;

-viral (including a cold sore or chicken pox), Fungal, bacterial and parasitic infections of the skin, Rosacea, rosacea, acne vulgaris, perioral dermatitis, skin manifestations of tuberculosis and syphilis, skin atrophy, skin ulcer, increased fractures receptacles skin, ichthyosis, perianal and genital itching;

— psoriatical eritrodermia, Guttate, exfoliative, pustular psoriasis;

- Hypersensitivity to the drug.

Pregnancy and lactation

Safety of Dajvobeta^® in pregnancy and lactation has not been established, Therefore, the use of the drug is only possible, When in the opinion of his therapy using require.

Cautions

It is not recommended to apply ointment on the skin, mucous membranes and scalp. After use of the drug should wash hands.

Risk gipercalziemii, while adhering to the recommended dosage is minimal. However, when applying Dajvobeta^® doses, exceeding the recommended maximum weekly dose (100 g), may develop hypercalcemia, quickly passing by reducing the dose or eliminate the medication.

Dajvobet^® contains potent CORTICOSTEROIDS, Therefore it is not recommended during its application to conduct concomitant treatment with other GCS.

You should avoid the use of the drug in large parts of the skin, comprising more than 30% body surface, as well as under occluzionnuyu cast, in the folds of skin, tk. This increases the probability of systemic development of the SCS and the suction system adverse reactions.

Side effects, such as suppression of the hypothalamic-pituitary-adrenal system with development of reversible secondary adrenal insufficiency or exacerbation of diabetes, associated with the system of designation GKS, and may occur with long-term use topicheskih GKS due to systemic absorption.

When psoriasis complications secondary infection should be antibacterial therapy, and while exacerbating infection product.

During treatment Dajvobetom^® You should limit or avoid excessive exposure to natural or artificial sunlight. Use Dajvobeta^® together with UV radiation is possible only, If the potential benefit outweighs the potential risk.

Use in Pediatrics

Clinical experience of applying Dajvobeta^® in children and adolescents under the age of 18 years missing.

Effects on ability to drive vehicles and management mechanisms

Dajvobet^® It does not affect the ability to drive vehicles and management mechanisms.

Overdose

Symptoms: increasing the calcium content in the blood, Suppression of the pituitary-adrenal system function with the development of reversible secondary adrenal insufficiency.

Treatment: removal of the drug; if necessary, symptomatic therapy. In cases of chronic toxicity of GCS should be lifted gradually.

Drug Interactions

So far, drug interaction drug Dajvobet^® not disclosed.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 2 year.

After first opening the tube shelf life – 3 Months.