Daivobet Ointment 30 g
LEO Pharma
LEO Pharma
Composition
Each gram of ointment contains
Calcipotriol — 50 µg.
Betamethasone — 0.5 mg.
Excipients
liquid paraffin (contains approx. 10 ppm alpha‑tocopherol), polypropylene glycol stearate (contains approx. 0.1% butylhydroxytoluene), alpha‑tocopherol, soft white paraffin (contains approx. 10 ppm alpha‑tocopherol).
Product Description
A combined topical medicine.
Calcipotriol is a synthetic analogue of the active metabolite of vitamin D. It inhibits keratinocyte proliferation and accelerates their differentiation.
Betamethasone is a topical corticosteroid with anti‑inflammatory, antipruritic, vasoconstrictive, and immunosuppressive effects.
Indications for Use
Chronic plaque psoriasis (psoriasis vulgaris).
Method of Administration and Dosage
For external use only.
Adults: apply once daily to affected skin areas.
Maximum daily dose: 15 g.
Maximum weekly dose: 100 g.
Dosage regimen should be determined by the physician.
Contraindications
Disorders of calcium metabolism.
Hypersensitivity to calcipotriol, betamethasone, or excipients.
Severe hepatic or renal impairment.
Viral (herpes, chickenpox), fungal, bacterial, or parasitic skin infections.
Rosacea, acne vulgaris, perioral dermatitis.
Cutaneous tuberculosis or syphilis.
Skin atrophy, ulcers, fragile vessels, ichthyosis.
Perianal and genital pruritus.
Psoriatic erythroderma, guttate, exfoliative, or pustular psoriasis.
Precautions
Risk of hypercalcemia is minimal at recommended doses, but may occur if weekly dose exceeds 100 g.
Contains a potent corticosteroid; concurrent use with other corticosteroids is not recommended.
Avoid application on more than 30% of body surface, under occlusive dressings, or in skin folds due to risk of systemic absorption.
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 worsening.
Corticosteroid‑related effects: skin atrophy, striae, telangiectasia, hypertrichosis, allergic dermatitis, depigmentation.
Systemic effects: hypercalcemia, hypercalciuria, adrenal suppression with prolonged high‑dose use.
Pregnancy and Lactation
Use only if prescribed by a physician, after benefit/risk assessment.
Storage Conditions
Store at temperatures not exceeding 30 °C.
Packaging
Carton box containing a tube of ointment 30 g.