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) manufactured by LEO Laboratories (Ireland)
Composition, form of production and packaging
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The cream for external use is uniform, white.
1 g

calcipotriol hydrate 52.2 μg,

which corresponds to the content of calcipotriol 50 μg

Excipients: macrogol cetostearate 18.0 mg, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) 72.0 mg, chloroallylmetamene chloride 0.5 mg, glycerol 85% 30.0 mg, disodium edetate dihydrate 0.5 mg, sodium hydrogen phosphate dihydrate 2.5 mg, paraffin liquid contains about 10 ppm alpha-tocopherol) 60.0 mg, paraffin white soft (contains about 10 ppm alpha-tocopherol) 150.0 mg, sodium hydroxide-qs to pH 7.5-9, water 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 analogue of the active 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 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. T 1/2 is very short.
INDICATIONS

- vulgar vulgar psoriasis.

DOSING MODE

Outwardly.
Adults apply a thin layer of the cream to the affected areas of the skin from 1 to 2 times / day.
The maximum daily dose should not exceed 15 g, the maximum weekly dose - not more than 100 g.

Therapeutic effect is observed after 1-2 weeks from the beginning of treatment.
The course of treatment should not exceed 6-8 weeks.
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 scaling of the skin, itching, erythema, contact dermatitis;
infrequent - exacerbation of psoriasis, eczema; very rarely - reversible hyperpigmentation, reversible depigmentation, reversible development of photosensitivity, periorbital or face edema.
CONTRAINDICATIONS

- hypersensitivity to calcipotriol and any auxiliary drug substance;

- diseases accompanied by a violation of calcium metabolism;

- Children under 18 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 18 years.

APPLICATION IN ELDERLY PATIENTS

With caution: age over 65 years.

SPECIAL INSTRUCTIONS

It is not recommended to apply Daivonex ® cream on face.
To avoid contact with the skin of the face, the hands should be thoroughly washed after each application of the cream.
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.
In case of application of the solution together with the 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 Daivonex ® cream).

Dianonex ® contains cetostearyl alcohol, which can cause a rash (eg, contact dermatitis).

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.
Symptoms of hypercalcemia are reduced concentration, fatigue, constipation, thirst and a decrease in muscle tone.
The level of calcium in blood serum is normalized after discontinuation of the drug.
DRUG INTERACTION

Daivonex ® cream should not be used together with topical preparations containing salicylic acid.

TERMS OF RELEASE FROM PHARMACY

The drug is dispensed without a prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years, after opening a tube - 6 months. Do not use after the expiration date printed on the package.
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