Daivonex - instructions for use, dose, side effects, contraindications

Active substanceCalcipotriolCalcipotriol

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Glenriaz

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Daivonex®

cream externally

Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Denmark

Daivonex®

ointment externally

Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Denmark

Daivonex®

solution externally

Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Denmark

Dosage form: & nbspcream for external use

Composition:

In 1 g of cream contains:

Active ingredient: calcipotriol monohydrate 52.2 μg (equivalent to calcipotriol 50.0 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 to 1.0 g.

Description:A homogeneous cream of white 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 is the basis of 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 is vulgar.

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 thin layer of the cream to the affected skin from 1 to 2 times a 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 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 flaky skin, itching, erythema, contact dermatitis;

Infrequently:

exacerbation of psoriasis, eczema;

Rarely:

reversible hyperpigmentation, reversible depigmentation, reversible development of photosensitivity, peri-orbital 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 serum (hypercalcemia). In this case, treatment should be discontinued. Symptoms of hypercalcemia are a decrease concentration, fatigue, constipation, thirst and a decrease in muscle tone. The level of calcium in the blood serum is normalized after discontinuation of the drug.

Interaction:

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

Special instructions:

It is not recommended to apply Daynonex® 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.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Cream for external use 0,005%.

Packaging:

For 30 g or 100 grams of cream in an aluminum tube, lacquered from the inside, a membrane and a screwed polyethylene lid,having a spike-side for the first opening of the protective membrane; 1 tube together with on application in a cardboard pack.

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 / 03

Date of registration:26.03.2010 / 01.02.2013

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

LEO Laboratories, Limited Ireland

Representation: & nbspNycomed Distribution Ltd.Nycomed Distribution Ltd.

Information update date: & nbsp17.03.2017

Illustrated instructions

Instructions

Daivonex® (Daivonex®)