Daivonex® (Daivonex®)

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

In 1 g of ointment contains:

Active substance: calcipotriol 50 μg.

Auxiliary substances: alpha-tocopherol 20 μg, macrogol stearate 50 mg, propylene glycol 100 mg, disodium edetate dihydrate 65 μg, sodium hydrogen phosphate dihydrate 260 μg, paraffin liquid (contains about 10 ppm alpha-tocopherol) 50 mg, water 26 mg, paraffin white Soft (contains about 10 ppm alpha-tocopherol) to 1 g.

Description:Translucent ointment from white to white with a yellowish hue of color.
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 with calcitriol.

Pharmacokinetics:

Transdermal absorption of calcipotriol is from 1% to 5% 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 vulgar (including in combination with acitretin, cyclosporine or corticosteroids).

Contraindications:

  • Hypersensitivity to calcipotriol and any auxiliary substance of the drug;
  • Diseases accompanied by a violation of calcium metabolism;
  • Children under 6 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 thin layer of ointment on the affected skin 2 times a day. If necessary, the frequency of application of the drug can be reduced to 1 time per day. The combined use of an ointment with acitretin or cyclosporin 2 times a day is effective and well tolerated.

Combined use of ointments with corticosteroids is carried out according to the scheme, for example, ointment - in the morning, corticosteroid - in the evening.

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

Therapeutic effect is usually observed after 1-2 weeks from the beginning of treatment. The duration of treatment is no more than 6-8 weeks.

Children

At the age of over 12 years: apply a thin layer of ointment on the affected skin 2 times a day, the maximum dose per week should not exceed 75 g.

At the age from 6 to 12 years: apply a thin layer of ointment on the affected skin 2 times a day. The maximum dose for a week is not more than 50 g.

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:

skin irritation, rash (scaly, erythematous, maculopapular, pustular, bullous), burning sensation, dryness and flaking of the 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® ointment should not be used with topical preparations containing salicylic acid.

Special instructions:

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

The appointment to patients younger than 18 years is possible only in short courses and on the skin surface, not exceeding 30% of the entire surface of the body.

Do not apply to large surfaces of lesions (more than 30% of the surface of the skin). It is not recommended for use on extensive skin surfaces or in severe chronic psoriasis (due to increased absorption and increased risk of hypercalcemia). If there is a need for using these forms of psoriasis, then careful monitoring of the concentration of calcium in the blood and urine is required.

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

When using the ointment with the solution, 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 Daivonex® ointment).

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 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:

Ointment for external use 0,005%.

Packaging:

30 g or 100 g of ointment in an aluminum tube, lacquered from the inside, with a protective membrane and with a screwed polyethylene cover, which has on the outside a spike for the first opening of the protective membrane; 1 tube 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 a tube - 6 months.

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

Terms of leave from pharmacies:Without recipe
Registration number:П N016256 / 01
Date of registration:26.03.2010 / 21.01.2013
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: & nbspLEO Pharmaceutical Products Ltd.LEO Pharmaceutical Products Ltd.
Information update date: & nbsp17.03.2017
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