Daivonex^® (Ointment) Instructions for Use

Marketing Authorization Holder

Leo Pharma, A/S (Denmark)

ATC Code

D05AX02 (Calcipotriol)

Active Substance

Calcipotriol (Rec.INN registered by WHO)

Dosage Form

Daivonex^®

Ointment for external use 50 mcg/1 g: tubes 30 g or 100 g

Dosage Form, Packaging, and Composition

Ointment for external use semi-transparent, from white to white with a yellowish tint.

	1 g
Calcipotriol monohydrate	52.2 mcg,
Equivalent to calcipotriol	50 mcg

Excipients : α-tocopherol – 20 mcg, macrogol stearate – 50 mg, propylene glycol – 100 mg, disodium edetate dihydrate – 65 mcg, sodium hydrogen phosphate dihydrate – 260 mcg, liquid paraffin – 50 mg, water – 26 mg, white soft paraffin – up to 1 g.

30 g – aluminum tubes (1) – cardboard boxes.
100 g – aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug with antiproliferative action for the treatment of psoriasis

Pharmacotherapeutic Group

Remedy for psoriasis

Pharmacological Action

Synthetic analogue of the most active metabolite of natural vitamin D₃. Causes dose-dependent inhibition of keratinocyte proliferation (significantly increased in patients with psoriasis) and accelerates their morphological differentiation. Has a negligible effect on calcium metabolism in the body. Is an inhibitor of T-lymphocyte activation induced by interleukin 1.

Pharmacokinetics

Transdermal absorption of calcipotriol is from 1% to 5% of the dose. Calcipotriol undergoes rapid biotransformation in the liver to form pharmacologically inactive metabolites. T_1/2 is very short.

Indications

Psoriasis.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
L40	Psoriasis

ICD-11 code	Indication
EA90.Z	Psoriasis, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For external use. Apply to the affected areas of the skin 2 times/day. The dose and duration of treatment are set individually, depending on age and the clinical situation.

The maximum daily dose for adults is 15 g, the weekly dose is 100 g.

The maximum weekly dose for children over 12 years of age is 75g.

The maximum weekly dose for children aged 6 to 12 years is 50 g.

The therapeutic effect is usually observed after 1-2 weeks from the start of treatment. The duration of the course is no more than 8 weeks.

Combined use of the agent with acitretin or cyclosporine is possible – this combination is effective and well tolerated.

Adverse Reactions

Allergic reactions very rarely – urticaria, angioedema.

Metabolism and nutrition disorders very rarely – hypercalcemia, hypercalciuria.

Skin and subcutaneous tissue disorders often – skin irritation, rash (scaly, erythematous, maculopapular, pustular, bullous), burning sensation, dry and flaky skin, itching, erythema; infrequently – exacerbation of psoriasis, eczema, contact dermatitis; very rarely – reversible hyperpigmentation, reversible depigmentation, reversible development of photosensitivity, periorbital edema or facial edema.

Contraindications

Hypersensitivity to calcipotriol; diseases accompanied by impaired calcium metabolism; children under 6 years of age.

Use in Pregnancy and Lactation

The safety of calcipotriol use during pregnancy and breastfeeding has not been established. It is not known whether Calcipotriol is excreted in breast milk. Use during pregnancy and breastfeeding should be avoided.

Use in Hepatic Impairment

Should be used with caution in acute hepatic failure.

Use in Renal Impairment

Should be used with caution in acute renal failure.

Pediatric Use

Contraindicated for use in children under 6 years of age.

Geriatric Use

Should be used with caution in patients over 65 years of age.

Special Precautions

Should be used with caution in hypercalcemia, hypercalciuria, hypervitaminosis D, history of nephrolithiasis, acute renal and hepatic failure; in patients over 65 years of age.

Application to the facial skin is not recommended.

Drug Interactions

Calcipotriol should not be used together with topical salicylic acid preparations.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer