Universal reference book for medicines
Product name: DAIVONEX ® (DAIVONEX)

Active substance: calcipotriol

Type: Antiproliferative drug for the treatment of psoriasis

Manufacturer: LEO Pharmaceutical Products Ltd.
A / S (LEO Pharma A / S) (Denmark)
Composition, form of production and packaging
?
Ointment for external use is translucent, from white to white with a yellowish tint of color.
1 g

calcipotriol monohydrate 52.2 μg,

is equivalent to calcipotriol 50 μg

Excipients:? -tocopherol-20 μg, macrogol stearate-50 mg, propylene glycol-100 mg, disodium edetate dihydrate-65 μg, sodium hydrophosphate dihydrate-260 μg, paraffin liquid-50 mg, water-26 mg, paraffin white soft- up to 1 g.

30 g - aluminum tubes (1) - cardboard packs.

100 g - aluminum tubes (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Means for treatment of psoriasis.

Calcipotriol is an analogous metabolite of natural vitamin D 3 .
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.

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. T 1/2 very short

INDICATIONS

- psoriasis vulgar (including in combination with acitretin, cyclosporine or corticosteroids).

DOSING MODE

Outwardly.

Adults apply a thin layer of ointment on the affected skin 2 times / day.
If necessary, the frequency of the drug can be reduced to 1 time / day. The combined use of an ointment with acitretin or cyclosporine 2 times / day is effective and well tolerated.
Combined use of ointments with GCS 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 over the age of 12: apply a thin layer of ointment on the affected skin 2 times / day, the maximum dose per week should not exceed 75 g;
at the age of 6 to 12 years - apply a thin layer of ointment on the affected skin 2 times / day; the maximum dose for a week is not more than 50 g.
SIDE EFFECT

Data are presented according to the following frequency: very often> 1/10;
often> 1/100 and <1/10; infrequently> 1/1000 and <1/100; rarely> 1/10000 and <1/1000;very rarely <1/10000, including individual cases.
From the immune system: very rarely - allergic reactions, hives, angioedema.

From the side of metabolism: very rarely - hypercalcemia, hypercalciuria.

From the skin and subcutaneous tissues: often - skin irritation, rash (scaly, erythematous, maculopapular, pustular, bullous), burning sensation, dryness and flaky skin, itching, erythema;
infrequently - exacerbation of psoriasis, eczema, contact dermatitis; very rarely - reversible hyperpigmentation, reversible depigmentation, reversible development of photosensitivity, periorbital or edema of the face.
CONTRAINDICATIONS

- hypersensitivity to calcipotriol and any auxiliary drug substance;

- diseases accompanied by a violation of calcium metabolism;

- Children under 6 years.

With caution: hypercalcemia, hypercalciuria, vitamin D hypervitaminosis, history of nephrolithiasis, 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 is excreted in breast milk. Avoid use during pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution: acute renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution: acute liver failure.

APPLICATION FOR CHILDREN

Contraindication: children under 6 years.

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.

APPLICATION IN ELDERLY PATIENTS

With caution: age over 65 years.

SPECIAL INSTRUCTIONS

It is not recommended to 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 the potential risk.
Impact on the ability to drive vehicles and manage mechanisms

Calcipotriol does not affect the ability to drive vehicles, mechanisms.

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.
DRUG INTERACTION

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

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