Daivonex ointment 50mkg, 30g

Psoriasis vulgaris (also in combination with acitretin, cyclosporine, or corticosteroids).

Outwardly.

Adults
Apply a thin layer of ointment to the affected skin 2 times a day. If necessary, the frequency of use of the drug can be reduced to 1 time per day. The combined use of ointment with acitretin or cyclosporin 2 times a day is effective and well tolerated.
The combined use of ointment 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. The
therapeutic effect is usually observed after 1-2 weeks from the start of treatment. The duration of the course of treatment is no more than 6-8 weeks.

Children
Over the age of 12: apply a thin layer of ointment to the affected skin 2 times a 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 to the affected skin 2 times a day ... The maximum dose per week is not more than 50 g.

1 g of the ointment contains:
Active substance : calcipotriol 50 mcg.
Excipients: alpha-tocopherol 20 mcg, macrogol stearate 50 mg, propylene glycol 100 mg, disodium edetate dihydrate 65 mcg, sodium hydrogen phosphate dihydrate 260 mcg, liquid paraffin (contains about 10 ppb of alpha-tocopherol) 50 mg, water 26 mg, white paraffin soft (contains about 10 ppb of alpha-tocopherol) up to 1 g.

- Hypersensitivity to calcipotriol and any excipient of the drug;

- Diseases accompanied by impaired calcium metabolism;

- Children under 6 years old.

With care - hypercalcemia, hypercalciuria, vitamin D hypervitaminosis, history of nephrolithiasis, age over 65, acute renal and hepatic failure.

Trade name of the drug: DaivonexЃ

International non-proprietary name:

Calcipotriol

Dosage form:

topical ointment

Composition
1 g of the ointment contains:
Active substance : calcipotriol 50 mcg.
Excipients: alpha-tocopherol 20 mcg, macrogol stearate 50 mg, propylene glycol 100 mg, disodium edetate dihydrate 65 mcg, sodium hydrogen phosphate dihydrate 260 mcg, liquid paraffin (contains about 10 ppb of alpha-tocopherol) 50 mg, water 26 mg, white paraffin soft (contains about 10 ppb of alpha-tocopherol) up to 1 g.

Description: translucent ointment from white to white with a yellowish tinge.

Pharmacotherapeutic group:

psoriasis treatment remedy.

ATX code: D05AX02

Pharmacological properties
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 using calcitriol.

Pharmacokinetics
Transdermal absorption of calcipotriol ranges from 1% to 5% of the dose. Calcipotriol undergoes rapid biotransformation in the liver with the formation of pharmacologically inactive metabolites. The half-life is very short.

Indications for use
Psoriasis vulgaris (including in combination with acitretin, cyclosporine or corticosteroids).

Contraindications

- Hypersensitivity to calcipotriol and any excipient of the drug;

- Diseases accompanied by impaired calcium metabolism;

- Children under 6 years old.

Application during pregnancy and lactation The
safety of the drug during pregnancy and lactation has not been established. It is not known whether calcipotriol is excreted in breast milk. Use during pregnancy and lactation should be avoided.

With care - hypercalcemia, hypercalciuria, vitamin D hypervitaminosis, history of nephrolithiasis, age over 65, acute renal and hepatic failure.

Method of administration and dosage
Outwardly.

Adults
Apply a thin layer of ointment to the affected skin 2 times a day. If necessary, the frequency of use of the drug can be reduced to 1 time per day. The combined use of ointment with acitretin or cyclosporin 2 times a day is effective and well tolerated.
The combined use of ointment 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. The
therapeutic effect is usually observed after 1-2 weeks from the start of treatment. The duration of the course of treatment is no more than 6-8 weeks.

Children
Over the age of 12: apply a thin layer of ointment to the affected skin 2 times a 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 to the affected skin 2 times a day ... The maximum dose per week is not more than 50 g.

Side effects
Data are presented in accordance with the following frequency of occurrence:

Very often> 1/10
Often> 1/100 and <1/10
Uncommon> 1/1000 and <1/100
Rarely> 1/10000 and <1/1000
Very rare <1/10000, including isolated cases

Immune system disorders:
Very rarely: allergic reactions, urticaria, angioedema;

Metabolic disorders:
Very rare: hypercalcemia, hypercalciuria;

Skin and subcutaneous tissue disorders:
Often: skin irritation, rash (scaly, erythematous, maculopapular, pustular, bullous), burning sensation, dryness and flaking of the skin, itching, erythema
Uncommon: exacerbation of psoriasis, eczema, contact dermatitis;
Very rare: reversible hyperpigmentation, reversible depigmentation, reversible development of photosensitivity, periorbital or facial edema.

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

Interaction with other medicinal products
DaivonexЃ ointment should not be used together with topical preparations containing salicylic acid.

Special instructions
It is not recommended to apply DaivonexЃ ointment on the face. To avoid contact of the drug with the skin of the face, hands should be thoroughly washed after each application of the ointment.

Prescription to patients under 18 years of age is possible only in short courses and on a skin surface not exceeding 30% of the entire body surface.

Should not be applied to large areas of lesions (more than 30% of the skin surface). Not recommended for use on large skin surfaces or in severe chronic psoriasis (due to increased absorption and increased risk of hypercalcemia). If it becomes necessary to use it for these forms of psoriasis, then careful monitoring of the concentration of calcium in the blood and urine is required.

Hypercalcemia can develop when the maximum weekly dose of calcipotriol is exceeded. When the drug is discontinued, the concentration of calcium in the blood quickly returns to normal.

If the ointment is used together with the solution, it should be borne in mind that the total dose of calcipotriol should not exceed 5 mg per week (1 ml of DaivonexЃ scalp solution corresponds to 1 g of DaivonexЃ ointment).

During treatment with DaivonexЃ, 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 UV light therapy if the physician believes the potential benefit outweighs the potential risk.

Influence on the ability to drive a car and moving mechanisms
Calcipotriol does not affect the ability to drive vehicles and mechanisms.

Release form
Ointment for external use 0.005%.
30 g or 100 g of ointment in an aluminum tube, lacquered from the inside, with a protective membrane and with a screw-on polyethylene lid having a spike on the outside for the first opening of the protective membrane; 1 tube with instructions for use in a cardboard box.

Shelf life
2 years, after opening the tube - 6 months.
Do not use after the expiration date printed on the package.

Storage conditions:

At a temperature not higher than 25 ? C.
Keep out of the reach of children.

Terms of dispensing from pharmacies:

Without recipe.