Дайвонекс
Producer: Nycomed Austria GmbH (Nikomed Austria Gmbh) Austria
Code of automatic telephone exchange: D05AX02
Release form: Soft dosage forms. Ointment. Cream.
General characteristics. Structure:
Contains in 1 g of ointment
Active agent: кальципотриол 50 mkg
Excipients: dinatrium эдетат, sodium hydrophosphate, a-tocopherol, liquid paraffin, polyethyleneglycol stearate, propylene glycol, paraffin white, water.
Contains in 1 g of cream:
Active agent: кальципотриол 50 mkg (52,2 mkg of a kaltsipotriol of hydrate are equivalent).
Excipients: polyethyleneglycol цетилат, cetostearyl alcohol, hloralilgeksamin chloride, dinatrium эдетат, sodium hydrophosphate, глицерол 85%, liquid paraffin, paraffin white, water.
For external use contains in 1 ml of solution:
Active agent: кальципотриол 50 mkg (52,2 mkg of a kaltsipotriol of hydrate are equivalent)
Excipients: hydroxypropyl cellulose, isopropanol, left menthol, propylene glycol, sodium citrate, water.
Pharmacological properties:
Pharmacodynamics. Kaltsipotriol is a vitamin D analog. Stimulates morphological differentiation and suppresses proliferation of keratinotsit that is the cornerstone of its medical effect at psoriasis.
Kaltsipotriol is powerful inhibitor of the activation of T lymphocytes caused by Interlaken 1.
Influence of a kaltsipotriol on calcic exchange is 100 times weaker, than D3 vitamin.
Pharmacokinetics. Transdermalny absorption of a kaltsipotriol makes from 1% to 5% of a dose. Kaltsipotriol is exposed to bystry biotransformation in a liver with formation pharmacological of inactive metabolites. The elimination half-life is very short.
Indications to use:
Psoriasis vulgar (including chronic psoriasis of a pilar part of the head).
Route of administration and doses:
Ointment
Adults
To apply with a thin layer on affected areas of skin 2 times a day. The maximum daily dose should not exceed 15 g, and the maximum dose in a week makes no more than 100 g.
The therapeutic effect is usually observed in 1-2 weeks from an initiation of treatment. Duration of a course of treatment is no more than 6-8 weeks.
Children
12 years are aged more senior: to apply with a thin layer on affected areas of skin 2 times a day, the maximum dose in a week should not exceed 75 g.
Aged from 6 up to 12 years: to apply with a thin layer on affected areas of skin 2 times a day. The maximum dose in a week no more than 50 g.
Cream
Adults
To apply with a thin layer on affected areas of skin 2 times a day.
The maximum daily dose should not exceed 15 g, the maximum dose in a week no more than 100 g.
The therapeutic effect is observed in 1-2 weeks from an initiation of treatment. The course of treatment should not exceed 6-8 weeks.
Solution
Adults
To apply a small amount of solution on affected areas of head skin 2 times a day (in the morning and in the evening). The total dose in a week should not exceed 60 ml.
Features of use:
Before use it is necessary to consult with the doctor.
It is not recommended to put ointment, cream and solution of Dayvoneks on a face. In order to avoid contact of drug with face skin of a hand it is necessary to wash up carefully after each use of ointment, cream or solution. The hypercalcemia develops at exceeding of the maximum dose of a kaltsipotriol in a week. At drug withdrawal concentration of calcium in blood is quickly normalized.
In case of use of solution together with ointment or cream it is necessary to consider that the total dose of a kaltsipotriol should not exceed 5 mg a week that corresponds to 60 ml of solution and 40 g of ointment or cream of Dayvoneks or 40 ml of solution and 60 g of ointment or cream (1 ml of solution of Dayvoneks for head skin corresponds to 1 g of ointment or cream of Dayvoneks).
Purpose of ointment and cream of Dayvoneks can be combined with PUVA therapy.
Influence on ability to drive the car and moving mechanisms
No.
Side effects:
The most typical: local irritation of skin.
Typical: erythema and itch of skin.
Atypical: dermatitis (including dermatitis of face skin and perioral at solution use); exacerbation of psoriasis.
Very rare: hyperpegmentation; hypercalcuria; hypercalcemia.
There are messages on development of a photosensitization and reactions of hypersensitivity, including very exceptional cases of a Quincke's disease and hypostasis in a face (at solution use).
Interaction with other medicines:
Дайвонекс it is impossible to use together with the drugs for topical administration containing salicylic acid.
Contraindications:
- Hypersensitivity to a kaltsipotriol and any auxiliary component of drug.
- The diseases which are followed by calcium metabolism disturbance.
With care - a hypercalcemia, a hypercalcuria, a hypervitaminosis of D, a nephrolithiasis, children's age at purpose of cream and solution (age up to 6 years at purpose of ointment) due to the lack of experience of use, the age is more senior than 65 years.
Use at pregnancy and in the period of a lactation
Safety of use of drug at pregnancy and in the period of a lactation is not established. It is not known whether it is allocated кальципотриол in breast milk. It is necessary to avoid use at pregnancy and a lactation.
Overdose:
Use of drug in the doses exceeding recommended can cause increase in concentration of calcium in blood. In this case treatment should be stopped.
Storage conditions:
At a temperature not above 25 °C, in the places unavailable to children. Ointment and external use cream: 2 years; Solution for external use: 3 years. Not to use after the period of validity specified on packaging.
Issue conditions:
Without recipe
Packaging:
Ointment: on 30 g or 100 g in the aluminum tuba varnished from within with the screw-on polyethylene cover. In a cardboard pack 1 tuba together with the application instruction.
Cream: on 30 g or 100 g in the aluminum tuba varnished from within with the screw-on polyethylene cover. In a cardboard pack 1 tuba together with the application instruction.
Solution: on 60 ml in a polyethylene bottle with a tip and the screw-on polyethylene cover, 1 bottle together with the application instruction is placed in a cardboard pack.