Dayvobet

General characteristics. Structure:

Active ingredients:

betamethasone Dipropionas of 0,643 mg (it is equivalent to betamethasone of 0,5 mg)

kaltsipotriola monohydrate of 0,052 mg (it is equivalent to a kaltsipotriol of 0,05 mg),

Inactive ingredients: paraffin liquid, polyoxypropylene-15-stearyl ether, alpha tocopherol, paraffin white soft. 

Pharmacological properties:

Kaltsipotriol – a synthetic analog of an active metabolite of vitamin D. Causes braking of proliferation of keratinotsit and accelerates their morphological differentiation.

Betamethasone – a glucocorticosteroid (GKS) for external use; renders local antiinflammatory, antipruritic, vasopressor and immunosuppressive action, however, exact mechanisms of antiinflammatory action of topical steroids are up to the end not clear. Use of occlusive bandages strengthens effect of topical GKS as at the same time their penetration into actually skin increases.

Pharmacokinetics. At use of DAYVOBETA absorption of a kaltsipotriol and betamethasone through the unimpaired skin makes less than 1%. When putting drug on psoriasis plaques and under occlusive bandages absorption of topical GKS increases. As in skin the depot of drug is created, its elimination comes from skin within several days. Betamethasone is metabolized in a liver and in kidneys with formation of glucuronides and sulfoethers, excretion is carried out through intestines and kidneys.

Indications to use:

Chronic vulgar blyashechny psoriasis.

Route of administration and doses:

Use for adults. Outwardly. Ointment is applied a thin layer on affected areas of skin of 1 times a day. Maximum day dose no more than 15 g; the maximum week dose should not exceed 100 g. The recommended duration of a course of treatment 4 weeks. Then Dayvobet can be applied repeatedly under observation of the doctor. The area of putting drug should not exceed 30% of a body surface.

Features of use:

It is not recommended to apply drug on face skin, mucous membranes and a pilar part of the head. After putting ointment it is necessary to wash up hands carefully.

The risk of development of a hypercalcemia at observance of the recommended mode of dosing is minimum. However, at use of DAYVOBETA in the doses exceeding the recommended maximum week dose (100 g) development of the hypercalcemia which is quickly passing at decrease in its dose or cancellation is possible.

DAYVOBET contains strong GKS therefore it is not recommended to carry out the accompanying treatment by other GKS.

It is recommended to avoid use of drug on the extensive sites of skin making more than 30% of a body surface and also under an occlusive bandage, to put in skin folds as it increases probability of system absorption of GKS and development of system side reactions.

By-effects, such as suppression гипоталамо - pituitary and adrenal system with development of reversible secondary adrenal insufficiency or a diabetes mellitus aggravation, GKS connected with system appointment, can be observed also at prolonged use of topical GKS, owing to system absorption. At a psoriasis complication consecutive infection, it is necessary to carry out antibacterial therapy, and at aggravation of an infection to cancel DAYVOBET.

Use for children. Experience of use of DAYVOBETA for children is younger than 18 years is absent.

Influence on ability to driving of motor transport and to control of mechanisms

No.

During treatment by Dayvobet doctors recommend to patients to limit or avoid excessive impact of a natural or artificial sunlight. Kaltsipotriol for topical administration has to be used with UF – light only if the doctor and the patient consider that the potential advantage outweighs potential risks. 

Side effects:

Side effects are classified depending on occurrence frequency:

the most frequent> 1/10

frequent> 1/100 and <1/10

infrequent> 1/1000 and <1/100

rare> 1/10000 and <1/1000

very rare <1/10000

From integuments and appendages of skin:

Frequent: itch, rash, burning sensation.

Infrequent: pain, irritation, dermatitis, erythema, exacerbation of psoriasis, pigmentation disturbance on site ointment applications, folliculitis.

Rare: pustular psoriasis.

Kaltsipotriol can cause local irritation of skin, an itch, burning, an acute pain, a xeroderma, an erythema, rash, dermatitis, eczema and an exacerbation of psoriasis.

Connect development of an atrophy of skin, teleangiectasias, striya, a folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, a depigmentation, colloid degeneration of skin, and also increase in risk of development of generalized pustular psoriasis, reaction with prolonged topical use of betamethasone (Dipropionas) hyper – and photosensitivity, including extremely exceptional cases of an angioedema and a face edema.

System reactions

(Very rare) connected using a kaltsipotriol: hypercalcemia or hypercalcuria.

Connected with topical use of betamethasone (rare, but sometimes heavy, especially at prolonged use, on big surfaces and when using occlusive bandages): suppression of function of bark of adrenal glands, cataract, infections, increase in intraocular pressure.

Interaction with other medicines:

It is not known.

Contraindications:

- The diseases which are followed by calcium metabolism disturbance
- Hypersensitivity to any of drug components
- The expressed renal and liver failure
- Virus (including herpes or chicken pox), fungal, bacterial and parasitic infections of skin, a rozatse, pink eels, vulgar eels, perioral dermatitis, skin displays of tuberculosis and syphilis, an atrophy of skin, a skin ulcer, the increased fragility of vessels of skin, an ichthyosis, a perianal and genital itch
- Psoriasis erythrosis, tear-shaped, exfoliative, pustular psoriasis.

Use at pregnancy and a lactation 

Safety of use of DAYVOBETA at pregnancy and a lactation is not established therefore drug can be used only when, according to the doctor, therapy with his use is necessary.

Overdose:

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

Treatment: to cancel drug and to carry out symptomatic therapy. In cases of chronic toxicity of GKS it is necessary to cancel gradually.

Storage conditions:

Period of validity - 2 years, after opening – 12 months. Not to use after expiry date. At a temperature not above 25 °C, in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

On 15, 30 and 60 g of ointment in a tuba aluminum, varnished from within, or in a tuba polyethylene laminated by aluminum foil, with the screw-on polyethylene cover; on 1 tuba together with the application instruction in a cardboard pack.