Daivonex® (Daivonex®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCalcipotriolCalcipotriol
Dosage form: & nbspsolution for external use
Composition:

In 1 ml of solution contains:

Active substance: calcipotriol monohydrate 52.2 g (equivalent to 50.0 mg Calcipotriol).

Excipients: Giproloza 1.00 mg Isopropanol 400.00 mg, 0.80 mg levomenthol, propylene glycol 40.00 mg Sodium citrate dihydrate 1.00 mg Water up to 1 ml.

Description:Transparent, colorless, slightly viscous liquid.
Pharmacotherapeutic group:Psoriasis treatment
ATX: & nbsp

D.05.A.X.02   Calcipotriol

D.05.A.X   Other preparations for the treatment of psoriasis for external use

Pharmacodynamics:

Calcipotriol is an analogue of the active metabolite of natural vitamin D3. Stimulates morphological differentiation and suppresses the proliferation of keratinocytes, which underlies its therapeutic effect in psoriasis.

Calcipotriol is an inhibitor of T lymphocyte activation caused by interleukin 1.

The effect of calcipotriol on calcium metabolism is 100 times weaker than when applied calcitriol.

Pharmacokinetics:

Transdermal absorption of calcipotriol is no more than 1% of the dose. Calcipotriol undergoes rapid biotransformation in the liver with the formation of pharmacologically inactive metabolites. The elimination half-life is very short.

Indications:

Psoriasis of the scalp.

Contraindications:

  • Hypersensitivity to calcipotriol and any auxiliary substance of the drug;
  • Diseases accompanied by a violation of calcium metabolism;
  • Children under 18 years.

Carefully:Hypercalcemia, hypercalciuria, vitamin hypervitaminosis D, nephrolithiasis in history, age over 65 years, acute renal and hepatic insufficiency.
Pregnancy and lactation:

The safety of the drug during pregnancy and lactation is not established. It is not known whether calcipotriol in breast milk. Avoid use during pregnancy and lactation.

Dosing and Administration:

Outwardly.

Adults apply a small amount of the solution to the affected areas of the scalp 2 times a day (morning and evening).The total dose for a week should not exceed 60 ml.

Side effects:

The data are presented in accordance with the following frequency of occurrence:

Often > 1/10

Often > 1/100 and <1/10

Infrequently > 1/1000 and <1/100

Rarely > 1/10000 and <1/1000

Rarely < 1/10000, including individual cases

Immune system disorders:

Rarely: allergic reactions, hives, angioedema;

Disorders from the metabolism:

Rarely:

hypercalcemia, hypercalciuria;

Disturbances from the skin and subcutaneous tissues:

Often:

burning sensation;

Often:

skin irritation, rash (scaly, erythematous, maculopapular, pustular, bullous), dry and flaky skin, itching, erythema;

Infrequently:

exacerbation of psoriasis, eczema, contact dermatitis;

Rarely:

reversible hyperpigmentation, reversible depigmentation, reversible development of photosensitivity, periorbital or edema of the face.

Overdose:

The use of the drug in doses exceeding the recommended dose can cause an increase in the concentration of calcium in the blood. In this case, treatment should be discontinued.

Interaction:

Diveonex® solution should not be used together with topical preparations,containing salicylic acid.

Special instructions:

Do not apply Dayvonex® solution on face. To avoid contact with the skin of the face, hands should be thoroughly washed after each use of the solution.

Hypercalcemia can develop if the maximum weekly dose of calcipotriol is exceeded. With the withdrawal of the drug, the concentration of calcium in blood quickly normalizes.

In case of application of the solution together with ointment or cream it should be taken into account that the total dose of calcipotriol should not exceed 5 mg per week (1 ml of Daivonex® solution for the scalp corresponds to 1 g of ointment or Daynonex® cream).

The Daivonex® solution contains propylene glycol, which can cause skin irritation.

During treatment with Daivonex®, doctors recommend that patients limit or avoid excessive exposure to natural or artificial sunlight. Treatment can be combined with selective and PUVA - phototherapy, as well as with treatment with UV light, if the doctor believes that the potential benefit outweighs the potential risk.

Effect on the ability to drive transp. cf. and fur:Calcipotriol does not affect the ability to drive vehicles, mechanisms.
Form release / dosage:

Solution for external use 0,005%.

Packaging:

For 60 ml of the drug in a polyethylene bottle with a tip and a screwed polyethylene lid; 1 bottle together with instructions for use in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years, after opening the bottle - 3 months.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe
Registration number:П N016256 / 02
Date of registration:24.03.2010 / 11.09.2012
Expiration Date:Unlimited
The owner of the registration certificate:Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Denmark
Manufacturer: & nbsp
Representation: & nbspNycomed Distribution Ltd.Nycomed Distribution Ltd.
Information update date: & nbsp17.03.2017
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