Daivobet Ointment 15 g

Daivobet Ointment 15 g

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.