Daivobet Ointment 15 g
LEO Pharma
LEO Pharma
Composition
Each gram of ointment contains
Calcipotriol 50 µg;
Betamethasone 0.5 mg.
Excipients
liquid paraffin (contains about 10 ppm α‑tocopherol), polypropylene glycol stearate (contains about 0.1% butylhydroxytoluene), α‑tocopherol, soft white paraffin (contains about 10 ppm α‑tocopherol).
Product Description
A combined medicinal product for external use.
Calcipotriol is a synthetic analogue of the active metabolite of vitamin D, which inhibits keratinocyte proliferation and accelerates their differentiation.
Betamethasone is a topical glucocorticosteroid with anti‑inflammatory, antipruritic, vasoconstrictive, and immunosuppressive effects.
Indications for Use
Chronic plaque psoriasis (vulgar type).
Method of Administration and Dosage
For external use.
Adults apply to affected skin areas once daily.
Maximum daily dose — not more than 15 g; maximum weekly dose — 100 g.
The optimal dosing regimen is determined by the physician.
Contraindications
Conditions associated with impaired calcium metabolism;
hypersensitivity to any component of the drug;
severe hepatic or renal insufficiency;
viral (including herpes or chickenpox), fungal, bacterial, and parasitic skin infections;
rosacea;
acne;
perioral dermatitis;
cutaneous manifestations of tuberculosis and syphilis;
skin atrophy, ulcers, ichthyosis;
perianal and genital itching;
psoriatic erythroderma; guttate, exfoliative, pustular psoriasis.
Precautions
Risk of hypercalcemia is minimal when recommended doses are observed.
Exceeding the weekly dose (100 g) may cause hypercalcemia, which resolves upon dose reduction or discontinuation.
Contains a potent corticosteroid; concomitant treatment with other corticosteroids is not recommended.
Avoid use on more than 30% of body surface, under occlusive dressings, or in skin folds due to increased risk of systemic absorption and adverse reactions.
Side Effects
Common: itching, rash, burning sensation.
Uncommon: pain, irritation, dermatitis, erythema, psoriasis exacerbation, pigmentation changes, folliculitis.
Rare: pustular psoriasis. Calcipotriol may cause local irritation, dryness, eczema, or psoriasis exacerbation.
Prolonged use of betamethasone may lead to skin atrophy, striae, telangiectasia, hypertrichosis, allergic contact dermatitis, depigmentation, generalized pustular psoriasis, hypersensitivity or photosensitivity reactions (rarely angioedema, facial swelling).
Systemic reactions: hypercalcemia, hypercalciuria, adrenal suppression, secondary adrenal insufficiency, hypercorticism including Cushing’s syndrome.
Pregnancy and Lactation
Use only under medical supervision.
Storage Conditions
Store at temperatures not exceeding 30°C.
Packaging
Carton box containing a 15 g tube.